Sample records for label safety study

  1. Food Labeling and Consumer Associations with Health, Safety, and Environment.

    PubMed

    Sax, Joanna K; Doran, Neal

    2016-12-01

    The food supply is complicated and consumers are increasingly calling for labeling on food to be more informative. In particular, consumers are asking for the labeling of food derived from genetically modified organisms (GMO) based on health, safety, and environmental concerns. At issue is whether the labels that are sought would accurately provide the information desired. The present study examined consumer (n = 181) perceptions of health, safety and the environment for foods labeled organic, natural, fat free or low fat, GMO, or non-GMO. Findings indicated that respondents consistently believed that foods labeled GMO are less healthy, safe and environmentally-friendly compared to all other labels (ps < .05). These results suggest that labels mean something to consumers, but that a disconnect may exist between the meaning associated with the label and the scientific consensus for GMO food. These findings may provide insight for the development of labels that provide information that consumers seek.

  2. 78 FR 24211 - Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-24

    ... container labels and carton labeling design, is the second in a series of three planned guidance documents...] Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To... entitled ``Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...

  3. Clinically relevant safety issues associated with St. John's wort product labels.

    PubMed

    Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C

    2008-07-17

    St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0-8) for 23.9% completeness. The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of counseling by HCPs and health store clerks. HCPs and consumers may benefit if the FDA re-examined labeling requirements for dietary supplements.

  4. Clinically relevant safety issues associated with St. John's wort product labels

    PubMed Central

    Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C

    2008-01-01

    Background St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Methods Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Results Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0–8) for 23.9% completeness. Conclusion The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of counseling by HCPs and health store clerks. HCPs and consumers may benefit if the FDA re-examined labeling requirements for dietary supplements. PMID:18637192

  5. Comprehension of hazard communication: effects of pictograms on safety data sheets and labels.

    PubMed

    Boelhouwer, Eric; Davis, Jerry; Franco-Watkins, Ana; Dorris, Nathan; Lungu, Claudiu

    2013-09-01

    The United Nations has proposed the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals to make hazard communication more uniform and to improve comprehension. Two experiments were conducted to test whether the addition of hazard and precautionary pictograms to safety data sheets and product labels would improve the transfer of information to users compared to safety data sheets and product labels containing text only. Additionally, naïve users, workers, and experts were tested to determine any potential differences among users. The effect of adding pictograms to safety data sheets and labels was statistically significant for some conditions, but was not significant across all conditions. One benefit of the addition of pictograms was that the time to respond to the survey questions decreased when the pictograms were present for both the SDS and the labels. GHS format SDS and labels do provide benefits to users, but the system will need further enhancements and modifications to continue to improve the effectiveness of hazard communication. The final rule to modify the HCS to include the Globally Harmonized System (GHS) for the Classification and Labelling of Chemicals announced by OSHA (2012b) will change the information content of every chemical SDS and label used in commerce. This study suggests that the inclusion of GHS hazard pictograms and precautionary pictograms to SDS and labels may benefit the user. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

  6. 40 CFR 1611.3 - Scope of permissible testimony.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... other types of CSB documents, including but not limited to safety recommendations, safety studies, safety proposals, safety accomplishments, reports labeled studies, and analysis reports, as they contain...

  7. Identifying Facilitators and Barriers for Patient Safety in a Medicine Label Design System Using Patient Simulation and Interviews.

    PubMed

    Dieckmann, Peter; Clemmensen, Marianne Hald; Sørensen, Trine Kart; Kunstek, Pina; Hellebek, Annemarie

    2016-12-01

    Medicine label design plays an important role in improving patient safety. This study aimed at identifying facilitators and barriers in a medicine label system to prevent medication errors in clinical use by health care professionals. The study design is qualitative and exploratory, with a convenience sample of 10 nurses and 10 physicians from different acute care specialties working in hospitals in the Capital Region of Denmark. In 2 patient simulation scenarios and a sorting task, the participants selected the medicines from a range of ampules, vials, and infusion bags. After each scenario and in the end of the study, the participants were interviewed. Notes were validated with the participants, and content was analyzed. The label design benefited from the standardized construction of the labels, the clear layout and font, and some warning signs. The complexity of the system and some inconsistencies (different meaning of colors) posed challenges, when considered with the actual application context, in which there is little time to get familiar with the design features. For optimizing medicine labels and obtaining the full benefit of label design features on patient safety, it is necessary to consider the context in which they are used.

  8. Assessment of the Impact of Scheduled Postmarketing Safety Summary Analyses on Regulatory Actions

    PubMed Central

    Sekine, S; Pinnow, EE; Wu, E; Kurtzig, R; Hall, M; Dal Pan, GJ

    2016-01-01

    In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-related label changes. Among 458 newly approved products, 300 were the subjects of a scheduled analysis; a new safety signal that resulted in a safety-related label change was found for 11 of these products. Less than 2% of 713 safety-related label changes were based on the scheduled analyses. Our study suggests that the safety summary analyses provide only marginal value over other pharmacovigilance activities. PMID:26853718

  9. Open-label extension studies: do they provide meaningful information on the safety of new drugs?

    PubMed

    Day, Richard O; Williams, Kenneth M

    2007-01-01

    The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. If undertaken primarily to gather more patient-years of exposure to the new drug in order to understand and gain confidence in its safety profile, open-label extension studies can play a useful and legitimate role in drug development and therapeutics. However, this can only occur if the open-label extension study is designed, executed, analysed and reported competently. Most of the value accrued in open-label extension studies is gained from a refinement in the perception of the expected incidence of adverse effects that have most likely already been identified as part of the preclinical and clinical trial programme. We still have to rely heavily on post-marketing safety surveillance systems to alert us to type B (unpredictable) adverse reactions because open-label extension studies are unlikely to provide useful information about these types of often serious and relatively rare adverse reactions. Random allocation into test and control groups is needed to produce precise incidence data on pharmacologically expected, or type A, adverse effects. Some increased confidence about incidence rates might result from the open-label extension study; however, as these studies are essentially uncontrolled and biased, the data are not of great value. Other benefits have been proposed to be gained from open-label extension studies. These include ongoing access to an effective but otherwise unobtainable medicine by the volunteers who participated in the phase III pivotal trials. However, there are unappreciated ethical issues about the appropriateness of enrolling patients whose response to previous treatment is uncertain, largely because treatment allocation in the preceding randomised, double-blind, controlled trial has not been revealed at the time of entry into the open-label extension study. Negative aspects of open-label extension studies revolve around their use as a marketing tool, as they build a market for the drug and generate pressure for subsidised access to the drug from consumers and their physicians. Consumers, institutions where these studies are conducted and research ethics committees need to be convinced of the motives, as well as the quality, of the open-label extension study and its execution before supporting such studies. Open-label extension studies do have a legitimate but limited place in the clinical development of new medicines. The negative perceptions about these studies have arisen because of perversion of acceptable rationales for this type of study and a failure to recognise (or disclose) the limitations resulting from the inherent weaknesses in their design. Increased human exposure to a new medicine under reasonably controlled circumstances to increase confidence in the safety of the medicine is an acceptable rationale for an open-label extension study, and a useful activity to increase the knowledge of the safety profile of a new medicine. However, this goal is increasingly being achieved by means other than open-label extension studies.

  10. Prevalence and determinants of non-standard motorcycle safety helmets amongst food delivery workers in Selangor and Kuala Lumpur.

    PubMed

    Kulanthayan, S; See, Lai Git; Kaviyarasu, Y; Nor Afiah, M Z

    2012-05-01

    Almost half of the global traffic crashes involve vulnerable groups such as pedestrian, cyclists and two-wheeler users. The main objective of this study was to determine the factors that influence standard of the safety helmets used amongst food delivery workers by presence of Standard and Industrial Research Institute of Malaysia (SIRIM) certification label. A cross sectional study was conducted amongst 150 food delivery workers from fast food outlets in the vicinity of Selangor and Kuala Lumpur. During observation, safety helmets were classified as standard safety helmet in the presence of SIRIM label and non-standard in the absence of the label. They were approached for questionnaire participation once consent was obtained and were requested to exchange their safety helmet voluntarily with a new one after the interview. Data analysis was carried out using SPSS. Chi square and logistic regression analysis was applied to determine the significance and odds ratio of the variables studied, respectively (penetration test, age, education level, knowledge, crash history, types of safety helmet, marital status and years of riding experience) against the presence of SIRIM label. The response rate for this study was 85.2%. The prevalence of non-standard helmets use amongst fast food delivery workers was 55.3%. Safety helmets that failed the penetration test had higher odds of being non-standard helmets compared with safety helmets passing the test. Types of safety helmet indicated half-shell safety helmets had higher odds to be non-standard safety helmets compared to full-shell safety helmets. Riders with more years of riding experience were in high odds of wearing non-standard safety helmets compared to riders with less riding experience. Non-standard (non-SIRIM approved) helmets were more likely to be half-shell helmets, were more likely to fail the standards penetration test, and were more likely to be worn by older, more experienced riders. The implications of these findings are discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

  11. Food safety labelling of chicken to prevent campylobacteriosis: consumer expectations and current practices.

    PubMed

    Allan, Philip D; Palmer, Chloe; Chan, Fiona; Lyons, Rebecca; Nicholson, Olivia; Rose, Mitchell; Hales, Simon; Baker, Michael G

    2018-03-27

    Campylobacter is the leading cause of bacterial gastroenteritis worldwide, and contaminated chicken is a significant vehicle for spread of the disease. This study aimed to assess consumers' knowledge of safe chicken handling practices and whether their expectations for food safety labelling of chicken are met, as a strategy to prevent campylobacteriosis. We conducted a cross-sectional survey of 401 shoppers at supermarkets and butcheries in Wellington, New Zealand, and a systematic assessment of content and display features of chicken labels. While 89% of participants bought, prepared or cooked chicken, only 15% knew that most (60-90%) fresh chicken in New Zealand is contaminated by Campylobacter. Safety and correct preparation information on chicken labels, was rated 'very necessary' or 'essential' by the majority of respondents. Supermarket chicken labels scored poorly for the quality of their food safety information with an average of 1.7/5 (95% CI, 1.4-2.1) for content and 1.8/5 (95% CI, 1.6-2.0) for display. Most consumers are unaware of the level of Campylobacter contamination on fresh chicken and there is a significant but unmet consumer demand for information on safe chicken preparation on labels. Labels on fresh chicken products are a potentially valuable but underused tool for campylobacteriosis prevention in New Zealand.

  12. Short communication: Labeling Listeria with anaerobic fluorescent protein for food safety studies.

    PubMed

    Landete, José M; Peirotén, Ángela; Medina, Margarita; Arqués, Juan L

    2017-01-01

    Many food safety-related studies require the tracking of inoculated food-borne pathogens to monitor their fate in food complex environments. In the current study, we demonstrate the potential of plasmids containing the fluorescence protein gene evoglow-Pp1 (Evocatal, Dusseldorf, Germany) as a real-time reporter system for Listeria strains. This anaerobic fluorescent protein provides an easily detectable phenotype of microorganisms for food safety studies. This work is the first to report a reliable method to identify fluorescently labeled Listeria strains in food ecosystems. Copyright © 2017 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  13. Toy Age-Labeling: An Overview for Pediatricians of How Toys Receive Their Age Safety and Developmental Designations.

    PubMed

    Kulak, Shuli; Stein, Ruth E K

    2016-07-01

    Injuries related to toys continue to cause significant childhood morbidity and mortality, despite considerable government regulation of the toy industry. Recent controversy related to toys that contain strong magnets demonstrate the dangers they pose to children. The pediatric community is often unaware of how toys receive their developmental and safety labeling and the degree to which age-labeling on toys can be discretionary. Toy labeling has 2 basic manifestations. The first, safety labeling for hazards like small parts, balloons, or small balls that may present a choking risk, is mandatory. The second, "developmental" age-labeling, describes the age of the children for which the toy is intended, and sometimes has discretionary components. This article provides a review of the regulations governing toy age-safety standards and how they are reflected on toy packaging to help pediatric practitioners apply safety advice across settings and patient characteristics. We review the existing age-labeling regulations and processes and discuss the major areas where children remain vulnerable despite labeling. Finally, we list some recommendations for counseling parents about toy safety. Copyright © 2016 by the American Academy of Pediatrics.

  14. Mining FDA drug labels using an unsupervised learning technique--topic modeling.

    PubMed

    Bisgin, Halil; Liu, Zhichao; Fang, Hong; Xu, Xiaowei; Tong, Weida

    2011-10-18

    The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering "topics" that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that might arise from specific medications via topics. The successful application of topic modeling on the FDA drug labeling demonstrates its potential utility as a hypothesis generation means to infer hidden relationships of concepts such as, in this study, drug safety and therapeutic use in the study of biomedical documents.

  15. 9 CFR 317.5 - Generically approved labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE..., without such labeling being submitted for approval to the Food Safety and Inspection Service in Washington... particular. (2) The Food Safety and Inspection Service shall select samples of generically approved labeling...

  16. Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products.

    PubMed

    Tassinari, Melissa S; Sahin, Leyla; Yao, Lynne P

    2015-08-01

    Obtaining human pregnancy data to inform product labeling is important for drug and biological products. Collection and analyses of safety data on their use during pregnancy is usually performed after approval. The Centers for Disease Control National Birth Defects Prevention Study has provided important data on the relationship between drug use in pregnancy and birth defects. The Pregnancy and Lactation Labeling Rule will set new and improved standards for the inclusion of information about the use of prescription drugs and biological products during pregnancy; the National Birth Defects Prevention Study, along with other data sources, will be critical for providing safety data to inform product labeling. © 2015 Wiley Periodicals, Inc.

  17. 75 FR 10740 - New Car Assessment Program (NCAP); Safety Labeling

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-09

    ... separated from each other by a dark line that is a minimum of 3 points in width. Also as is currently required, the entire safety rating label would be required to be surrounded by a solid dark line that is a... dark background. \\4\\ The full study report is available at http://www.regulations.gov in Docket No...

  18. 76 FR 74723 - New Car Assessment Program (NCAP); Safety Labeling

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-01

    ... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 575 [Docket No. NHTSA 2010-0025] RIN 2127-AK51 New Car Assessment Program (NCAP); Safety Labeling AGENCY: National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT). ACTION...

  19. Long-Term, Open-Label Safety and Efficacy of Atomoxetine in Adults with ADHD: Final Report of a 4-Year Study

    ERIC Educational Resources Information Center

    Adler, Lenard A.; Spencer, Thomas J.; Williams, David W.; Moore, Rodney J.; Michelson, David

    2008-01-01

    Objective: Previously, data from 97 weeks of open-label atomoxetine treatment of adults with attention-deficit/hyperactivity disorder (ADHD) were reported. This final report of that study presents results from over 4 years of treatment. Method: Results were derived from the study of 384 patients (125 patients remaining in the open-label trial…

  20. 16 CFR 1615.5 - Labeling requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE.... (a) Care labels. All items of children's sleepwear shall be labeled with precautionary instructions... accordance with rules and regulations established by the Consumer Product Safety Commission. (b) [Reserved...

  1. Predicament of Chinese legislation on genetically modified food (GMF) labeling management and solutions - from the perspective of the new food safety law.

    PubMed

    Li, Wei; Li, Han

    2017-11-01

    This paper considers the background of Article 69 of the newly revised Food Safety Law in China in combination with the current situation of Chinese legislation on GMF labeling management, compared with a foreign genetically modified food labeling management system, revealing deficiencies in the Chinese legislation with respect to GMF labeling management, and noting that institutions should properly consider the GMF labeling management system in China. China adheres to the principle of mandatory labeling based on both product and processes in relation to GMFs and implements a system of process-centered mandatory labeling under a negotiation-construction form. However, China has not finally defined the supervision mode of mandatory labeling of GMFs through laws, and this remains a challenge for GMF labeling management when two mandatory labeling modes coexist. Since April 2015 and October 1, 2015 when the Food Safety Law was revised and formally implemented respectively, the applicable judicial interpretations and enforcement regulations have not made applicable revisions and only principle-based terms have been included in the Food Safety Law, it is still theoretically and practically difficult for mandatory labeling of GMFs in juridical practices and conflicts between the principle of GMF labeling and the purpose that safeguards consumers' right to know remain. The GMF labeling system should be legislatively and practically improved to an extent that protects consumers' right to know. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

  2. Label Design Affects Medication Safety in an Operating Room Crisis: A Controlled Simulation Study.

    PubMed

    Estock, Jamie L; Murray, Andrew W; Mizah, Margaret T; Mangione, Michael P; Goode, Joseph S; Eibling, David E

    2018-06-01

    Several factors contribute to medication errors in clinical practice settings, including the design of medication labels. The objective of this study was to quantify the impact of label design on medication safety in a realistic, high-stress clinical situation. Ninety-six anesthesia trainee participants were randomly assigned to either the redesigned or the current label condition. Participants were blinded to the study's focus on medication label design and their assigned label condition. Each participant was the sole anesthesia provider in a simulated operating room scenario involving an unexpected vascular injury. The surgeon asked the participant to administer hetastarch to the simulated patient because of hemodynamic instability. The fluid drawer of the anesthesia cart contained three 500-ml intravenous bags of hetastarch and one 500-ml intravenous bag of lidocaine. We hypothesized that redesigned labels would help participants correctly select hetastarch from the cart. If the participants incorrectly selected lidocaine from the cart, we hypothesized that the redesigned labels would help participants detect the lidocaine before administration. The percentage of participants who correctly selected hetastarch from the cart was significantly higher for the redesigned labels than the current labels (63% versus 40%; odds ratio, 2.61 [95% confidence interval, 1.1-6.1]; P = 0.03). Of the participants who incorrectly selected lidocaine from the cart, the percentage who detected the lidocaine before administration did not differ by label condition. The redesigned labels helped participants correctly select hetastarch from the cart, thus preventing some potentially catastrophic medication errors from reaching the simulated patient.

  3. 16 CFR 1500.133 - Extremely flammable contact adhesives; labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... under the Consumer Product Safety Act extremely flammable contact adhesives covered by this labeling... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Extremely flammable contact adhesives; labeling. 1500.133 Section 1500.133 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL...

  4. 16 CFR 1500.133 - Extremely flammable contact adhesives; labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... under the Consumer Product Safety Act extremely flammable contact adhesives covered by this labeling... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Extremely flammable contact adhesives; labeling. 1500.133 Section 1500.133 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL...

  5. Clinical imaging in regenerative medicine

    PubMed Central

    Naumova, Anna V; Modo, Michel; Moore, Anna; Murry, Charles E; Frank, Joseph A

    2014-01-01

    In regenerative medicine, clinical imaging is indispensable for characterizing damaged tissue and for measuring the safety and efficacy of therapy. However, the ability to track the fate and function of transplanted cells with current technologies is limited. Exogenous contrast labels such as nanoparticles give a strong signal in the short term but are unreliable long term. Genetically encoded labels are good both short- and long-term in animals, but in the human setting they raise regulatory issues related to the safety of genomic integration and potential immunogenicity of reporter proteins. Imaging studies in brain, heart and islets share a common set of challenges, including developing novel labeling approaches to improve detection thresholds and early delineation of toxicity and function. Key areas for future research include addressing safety concerns associated with genetic labels and developing methods to follow cell survival, differentiation and integration with host tissue. Imaging may bridge the gap between cell therapies and health outcomes by elucidating mechanisms of action through longitudinal monitoring. PMID:25093889

  6. Survey of safety practices among hospital laboratories in Oromia Regional State, Ethiopia.

    PubMed

    Sewunet, Tsegaye; Kebede, Wakjira; Wondafrash, Beyene; Workalemau, Bereket; Abebe, Gemeda

    2014-10-01

    Unsafe working practices, working environments, disposable waste products, and chemicals in clinical laboratories contribute to infectious and non-infectious hazards. Staffs, the community, and patients are less safe. Furthermore, such practices compromise the quality of laboratory services. We conducted a study to describe safety practices in public hospital laboratories of Oromia Regional State, Ethiopia. Randomly selected ten public hospital laboratories in Oromia Regional State were studied from Oct 2011- Feb 2012. Self-administered structured questionnaire and observation checklists were used for data collection. The respondents were heads of the laboratories, senior technicians, and safety officers. The questionnaire addressed biosafety label, microbial hazards, chemical hazards, physical/mechanical hazards, personal protective equipment, first aid kits and waste disposal system. The data was analyzed using descriptive analysis with SPSS version16 statistical software. All of the respondents reported none of the hospital laboratories were labeled with the appropriate safety label and safety symbols. These respondents also reported they may contain organisms grouped under risk group IV in the absence of microbiological safety cabinets. Overall, the respondents reported that there were poor safety regulations or standards in their laboratories. There were higher risks of microbial, chemical and physical/mechanical hazards. Laboratory safety in public hospitals of Oromia Regional State is below the standard. The laboratory workers are at high risk of combined physical, chemical and microbial hazards. Prompt recognition of the problem and immediate action is mandatory to ensure safe working environment in health laboratories.

  7. [Preliminary results of an open-label observational study evaluating the efficacy and safety of Prolia used in women with postmenopausal osteoporosis].

    PubMed

    Ershova, O B; Lesniak, O M; Belova, K Iu; Nazarova, A V; Manovitskaia, A V; Musaeva, T M; Musraev, R M; Nurlygaianov, R Z; Rozhinskaia, L Ia; Skripnikova, I A; Toroptsova, N V

    2014-01-01

    To evaluate the efficacy and safety of Denosumab (Prolia), a first-line osteoporosis (OP) medication that is a fully human monoclonal antibody to the receptor activator of nuclear factor xB ligand (RANKL), within an open-label observational study. Patients aged 50 years or older with postmenopausal OP, who were treated with Prolia in clinical practice, were examined. The concentrations of the bone resorption (BR) marker of C-terminal telopeptide and other laboratory indicators (total serum calcium, total alkaline phosphatase, and creatinine) were measured following 3 months. Adverse drug reactions were recorded. Three months after initiation of the investigation, there was a significant decrease in the BR marker C-terminal telopeptide (by 89%; p<0.0001). There were rare adverse reactions: hypocalcemia in 3 (5.9%) patients, arthralgias in 2 (3.9%), and eczema in 1 (1.9%). There were neither serious adverse events nor study withdrawal cases. The preliminary results of the open-label study of Prolia in postmenopausal OP suggest that the significantly lower BR activity determines the efficacy of this drug and its high safety.

  8. 16 CFR § 1500.133 - Extremely flammable contact adhesives; labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... under the Consumer Product Safety Act extremely flammable contact adhesives covered by this labeling... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Extremely flammable contact adhesives; labeling. § 1500.133 Section § 1500.133 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL...

  9. 21 CFR 314.81 - Other postmarketing reports.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... to safety (for example, epidemiologic studies or analyses of experience in a monitored series of... times two copies of the following reports: (1) NDA—Field alert report. The applicant shall submit... information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new study...

  10. 21 CFR 314.81 - Other postmarketing reports.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... to safety (for example, epidemiologic studies or analyses of experience in a monitored series of... times two copies of the following reports: (1) NDA—Field alert report. The applicant shall submit... information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new study...

  11. 21 CFR 314.81 - Other postmarketing reports.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... to safety (for example, epidemiologic studies or analyses of experience in a monitored series of... times two copies of the following reports: (1) NDA—Field alert report. The applicant shall submit... information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new study...

  12. 21 CFR 314.81 - Other postmarketing reports.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... to safety (for example, epidemiologic studies or analyses of experience in a monitored series of... times two copies of the following reports: (1) NDA—Field alert report. The applicant shall submit... information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new study...

  13. 9 CFR 317.5 - Generically approved labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... the Food Safety and Inspection Service in Washington or the field, provided the labeling is in..., and is not otherwise false or misleading in any particular. (2) The Food Safety and Inspection Service...

  14. 9 CFR 317.5 - Generically approved labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... the Food Safety and Inspection Service in Washington or the field, provided the labeling is in..., and is not otherwise false or misleading in any particular. (2) The Food Safety and Inspection Service...

  15. 9 CFR 317.5 - Generically approved labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... the Food Safety and Inspection Service in Washington or the field, provided the labeling is in..., and is not otherwise false or misleading in any particular. (2) The Food Safety and Inspection Service...

  16. 9 CFR 317.5 - Generically approved labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... the Food Safety and Inspection Service in Washington or the field, provided the labeling is in..., and is not otherwise false or misleading in any particular. (2) The Food Safety and Inspection Service...

  17. Consumer preferences for food allergen labeling.

    PubMed

    Marra, Carlo A; Harvard, Stephanie; Grubisic, Maja; Galo, Jessica; Clarke, Ann; Elliott, Susan; Lynd, Larry D

    2017-01-01

    Food allergen labeling is an important tool to reduce risk of exposure and prevent anaphylaxis for individuals with food allergies. Health Canada released a Canadian food allergen labeling regulation (2008) and subsequent update (2012) suggesting that research is needed to guide further iterations of the regulation to improve food allergen labeling and reduce risk of exposure. The primary objective of this study was to examine consumer preferences in food labeling for allergy avoidance and anaphylaxis prevention. A secondary objective was to identify whether different subgroups within the consumer population emerged. A discrete choice experiment using a fractional factorial design divided into ten different versions with 18 choice-sets per version was developed to examine consumer preferences for different attributes of food labeling. Three distinct subgroups of Canadian consumers with different allergen considerations and food allergen labeling needs were identified. Overall, preferences for standardized precautionary and safety symbols at little or no increased cost emerged. While three distinct groups with different preferences were identified, in general the results revealed that the current Canadian food allergen labeling regulation can be improved by enforcing the use of standardized precautionary and safety symbols and educating the public on the use of these symbols.

  18. 75 FR 71344 - Uniform Compliance Date for Food Labeling Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-23

    ... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 317 and 381 [Docket No. FSIS-2010-0031] RIN 0583-AD Uniform Compliance Date for Food Labeling Regulations AGENCY: Food Safety and Inspection Service, USDA. ACTION: Final rule. SUMMARY: The Food Safety and Inspection Service...

  19. 16 CFR 1205.35 - Product certification and labeling by manufacturers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by manufacturers. 1205.35 Section 1205.35 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR WALK-BEHIND POWER LAWN MOWERS Certification § 1205.35 Product...

  20. 16 CFR 1205.36 - Product certification and labeling by importers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by importers. 1205.36 Section 1205.36 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR WALK-BEHIND POWER LAWN MOWERS Certification § 1205.36 Product...

  1. Six-month, open-label study of hydrocodone extended release formulated with abuse-deterrence technology: Safety, maintenance of analgesia, and abuse potential.

    PubMed

    Hale, Martin E; Ma, Yuju; Malamut, Richard

    2016-01-01

    To evaluate long-term safety, maintenance of analgesia, and aberrant drug-related behaviors of hydrocodone extended release (ER) formulated with CIMA® Abuse-Deterrence Technology. Phase 3, multicenter, open-label extension. Fifty-six US centers. Adults with chronic low back pain completing a 12-week placebocontrolled study of abuse-deterrent hydrocodone ER were eligible. One hundred eighty-two patients enrolled and received ≥1 dose of study drug, 170 entered openlabel treatment, and 136 completed the study. Patients receiving hydrocodone ER in the 12-week, placebo-controlled study continued their previous dose unless adjustment was needed; those previously receiving placebo (n=78) underwent dose titration/adjustment to an analgesic dose (15-90 mg every 12 hours). Patients received 22 weeks of open-label treatment. adverse events (AEs). Maintenance of analgesia: worst pain intensity (WPI) and average pain intensity (API) at each study visit. Aberrant drug behavior: study drug loss and diversion. AEs were reported for 65/182 (36 percent) patients during dose titration/ adjustment and 88/170 (52 percent) during open-label treatment. No treatmentrelated serious AEs were reported. There were no clinically meaningful trends in other safety assessments, including physical examinations and pure tone audiometry. One patient receiving hydrocodone ER 30 mg twice daily experienced a severe AE of neurosensory deafness that was considered treatment related. Mean WPI and API remained steady throughout open-label treatment. Six (3 percent) patients reported medication loss, and 5 (3 percent) reported diversion. Abuse-deterrent hydrocodone ER was generally well tolerated in patients with chronic low back pain, maintained efficacy, and was associated with low rates of loss and diversion.

  2. Assessment of self-reporting reading of medicine's labels and the resources of information about medicines in general public in Malaysia.

    PubMed

    Dawood, Omar T; Hassali, Mohamed A; Saleem, Fahad; Ibrahim, Inas R

    2018-04-01

    This study was undertaken to assess the people's self-reported reading of medicine labels and its associated factors and to assess the sources of information about medicines among general public. A cross-sectional study was carried out among general public in the State of Penang, Malaysia. A total of 888 participants were conveniently selected and completed the survey. A self-administered questionnaire was used to obtain the data from all the participants. Most of the participants (74.2%) reported that they have adequate information about medicines provided on their medicine labels. In addition, 86.9% of them reported that they read their medicine's label for the directions of usage and 84.3% for the dosage instruction. However, 42.1% of the participants do not read their medicine's label for the active ingredients, and 33% of them do not read their medicine's label for the safety information. In addition, 36.5% of the respondents did not read the label of medicine for the symptoms which can be used for. However, females, Malay respondents, and higher education level (college/university) were more likely to self-reported the reading medicine's label. Females were more likely to read the labels of medicines compared with males (OR = 1.6, 95% CI 1.20-2.13, P  = .001). The reading of medicine labels was predicted by females, Malay respondents, and higher educated people. Health educational programs are needed to clarify label's information that can help in concept of patient safety.

  3. Long-term safety of icatibant treatment of patients with angioedema in real-world clinical practice.

    PubMed

    Zanichelli, A; Maurer, M; Aberer, W; Caballero, T; Longhurst, H J; Bouillet, L; Fabien, V; Andresen, I

    2017-06-01

    The Icatibant Outcome Survey (IOS) is an observational study monitoring safety and effectiveness of icatibant in the real-world setting. We analyzed safety data from 3025 icatibant-treated attacks in 557 patients (enrolled between July 2009 and February 2015). Icatibant was generally well tolerated. Excluding off-label use and pregnancy, 438 patients (78.6%) did not report adverse events (AEs). The remaining 119 (21.4%) patients reported 341 AEs, primarily gastrointestinal disorders (19.6%). Of these, 43 AEs in 17 patients (3.1%) were related to icatibant. Serious AEs (SAEs) occurred infrequently. A total of 143 SAEs occurred in 59 (10.6%) patients; only three events (drug inefficacy, gastritis, and reflux esophagitis) in two patients were considered related to icatibant. Notably, no SAEs related to icatibant occurred in patients with cardiovascular disease, nor in those using icatibant at a frequency above label guidelines. Additionally, no major differences were noted in AEs occurring in on-label vs off-label icatibant users. © 2016 The Authors. Allergy Published by John Wiley & Sons Ltd.

  4. Designing a strategy to promote safe, innovative off-label use of medications.

    PubMed

    Ansani, Nicole; Sirio, Carl; Smitherman, Thomas; Fedutes-Henderson, Bethany; Skledar, Susan; Weber, Robert J; Zgheib, Nathalie; Branch, Robert

    2006-01-01

    Innovative off-label medication use (defined as prescribing with reasonable rationale for use, but insufficient evidence to allay safety, efficacy, and cost-effectiveness concerns, yet is not clinical research) is common practice and provides challenges to ensuring high-quality health care and patient safety. This article describes a strategy to promote policy and standardization of innovative off-label medication use, ensure oversight of patient safety, and prospectively assess efficacy. A multidisciplinary group developed a policy and process to regulate innovative off-label medication use that standardizes formulary review, maximizes peer expertise input, and minimizes institution liability by evaluating the effectiveness of use, promoting evidence-based practices, and ensuring ethical obligations to patients and society. This strategy has been implemented through institutional staff structure. The review process balances benefits/risks for biologically plausible therapy that lacks rigorous data support. The authors' strategy illustrates collaboration that enables a priori consideration for innovative off-label medication use while providing safety surveillance and outcomes monitoring.

  5. 49 CFR 575.302 - Vehicle labeling of safety rating information (compliance required for model year 2012 and later...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... this section is to aid potential purchasers in the selection of new passenger motor vehicles by providing them with safety rating information developed by NHTSA in its New Car Assessment Program (NCAP... and rating program. (c) Definitions. (1) Monroney label means the label placed on new automobiles with...

  6. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  7. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  8. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  9. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  10. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  11. A primer of drug safety surveillance: an industry perspective. Part II: Product labeling and product knowledge.

    PubMed

    Allan, M C

    1992-01-01

    To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part II of this series discusses specific issues regarding product labeling, such as developing the labeling, changing the labeling, and the legal as well as commercial ramifications of the contents of the labeling. An adverse event report scenario is further analyzed and suggestions are offered for maintaining the product labeling as an accurate reflection of the drug safety surveillance data. This article also emphasizes the necessity of product knowledge in adverse event database management. Both scientific and proprietary knowledge are required. Acquiring product knowledge is a part of the day-to-day activities of drug safety surveillance. A knowledge of the history of the product may forestall adverse publicity, as shown in the illustration. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered to facilitate communication of a review of adverse event data for various audiences. Careful drug safety surveillance is beneficial to the health of the public and the commercial well-being of the manufacturer. Attention to the basic principles is essential and, as illustrated, may be sufficient to resolve some problems.

  12. 49 CFR 575.301 - Vehicle labeling of safety rating information (applicable unless a vehicle is subject to § 575.302).

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    .... The purpose of this section is to aid potential purchasers in the selection of new passenger motor vehicles by providing them with safety rating information developed by NHTSA in its New Car Assessment... label means the label placed on new automobiles with the manufacturer's suggested retail price and other...

  13. 75 FR 383 - Canned Pacific Salmon Deviating From Identity Standard; Extension of Temporary Permit for Market...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ... of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS-820.... Barbara Schneeman, Director, Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety...

  14. Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014.

    PubMed

    Pinnow, Ellen; Amr, Sania; Bentzen, Søren M; Brajovic, Sonja; Hungerford, Laura; St George, Diane Marie; Dal Pan, Gerald

    2017-12-20

    We ascertained a comprehensive list of postmarket safety outcomes, defined as a safety-related market withdrawal or an update to a safety-related section of product label for 278 new molecular entity drugs (NMEs) with a follow-up period of up to 13 years. At least one safety-related update was added to 195 (70.1%) labels of the drugs studied. Updates occurred as early as 160 days after approval and throughout the follow-up period. The period between the second and eighth postapproval year was the most active, with a slight attenuation thereafter. The times to the first safety outcome were significantly shorter for NMEs approved with a fast-track designation (P = 0.02) or under an accelerated approval using a surrogate endpoint (P = 0.03). Our findings underscore the importance of a robust safety surveillance system throughout a drug's lifecycle and for practitioners and patients to remain updated on drug safety profiles. © 2017, The American Society for Clinical Pharmacology and Therapeutics.

  15. Soil Fumigant Labels - Dimethyl Disulfide (DMDS)

    EPA Pesticide Factsheets

    Search by EPA registration number, product name, or company and follow the link to the Pesticide Product Labeling System (PPLS) for label details. Updated labels include new safety requirements for buffer zones and related measures.

  16. Risperidone in Children with Disruptive Behavior Disorders and Subaverage Intelligence: A 1-Year, Open-Label Study of 504 Patients

    ERIC Educational Resources Information Center

    Croonenberghs, Jan; Fegert, Joerg M.; Findling, Robert L.; de Smedt, Goedele; van Dongen, Stefan

    2005-01-01

    Objective: To determine the long-term safety and effectiveness of risperidone for severe disruptive behaviors in children. Method: A multisite, 1-year, open-label study of patients aged 5 to 14 years with disruptive behaviors and subaverage intelligence was conducted. Results: Seventy-three percent of the 504 patients enrolled completed the study.…

  17. Atomoxetine and Methylphenidate Treatment in Children with ADHD: The Efficacy, Tolerability and Effects on Executive Functions

    ERIC Educational Resources Information Center

    Yildiz, Ozlem; Sismanlar, Sahika G.; Memik, Nursu Cakin; Karakaya, Isik; Agaoglu, Belma

    2011-01-01

    The aim of this study was to compare the safety, efficacy, tolerability, and the effects of atomoxetine and OROS-MPH on executive functions in children with ADHD. This study was an open-label study that only included two medication groups. Children were randomized to open-label atomoxetine or OROS-MPH for 12 weeks. Primary efficacy measures were…

  18. A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions—A SONAR Report

    PubMed Central

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P.; McKoy, June M.; Lopez, Isaac S.; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R.; Ray, Paul; Sartor, Oliver; Bennett, Charles L.

    2012-01-01

    Purpose: Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Methods: Case study. Results: The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. Conclusion: New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon. PMID:23598851

  19. A tale of two citizens: a State Attorney General and a hematologist facilitate translation of research into US Food and Drug Administration actions--a SONAR report.

    PubMed

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P; McKoy, June M; Lopez, Isaac S; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R; Ray, Paul; Sartor, Oliver; Bennett, Charles L

    2012-11-01

    Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Case study. The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon.

  20. Drug labeling and exposure in neonates.

    PubMed

    Laughon, Matthew M; Avant, Debbie; Tripathi, Nidhi; Hornik, Christoph P; Cohen-Wolkowiez, Michael; Clark, Reese H; Smith, P Brian; Rodriguez, William

    2014-02-01

    Federal legislation has led to a notable increase in pediatric studies submitted to the Food and Drug Administration (FDA), resulting in new pediatric information in product labeling. However, approximately 50% of drug labels still have insufficient information on safety, efficacy, or dosing in children. Neonatal information in labeling is even scarcer because neonates comprise a vulnerable subpopulation for which end-point development is lagging and studies are more challenging. To quantify progress made in neonatal studies and neonatal information in product labeling as a result of recent legislation. We identified a cohort of drug studies between 1997 and 2010 that included neonates as a result of pediatric legislation using information available on the FDA website. We determined what studies were published in the medical literature, the legislation responsible for the studies, and the resulting neonatal labeling changes. We then examined the use of these drugs in a cohort of neonates admitted to 290 neonatal intensive care units (NICUs) (the Pediatrix Data Warehouse) in the United States from 2005 to 2010. Infants exposed to a drug studied in neonates as identified by the FDA website. Number of drug studies with neonates and rate of exposure per 1000 admissions among infants admitted to an NICU. In a review of the FDA databases, we identified 28 drugs studied in neonates and 24 related labeling changes. Forty-one studies encompassed the 28 drugs, and 31 (76%) of these were published. Eleven (46%) of the 24 neonatal labeling changes established safety and effectiveness. In a review of a cohort of 446,335 hospitalized infants, we identified 399 drugs used and 1,525,739 drug exposures in the first 28 postnatal days. Thirteen (46%) of the 28 drugs studied in neonates were not used in NICUs; 8 (29%) were used in fewer than 60 neonates. Of the drugs studied, ranitidine was used most often (15,627 neonates, 35 exposures per 1000 admissions). Few drug labeling changes made under pediatric legislation include neonates. Most drugs studied are either not used or rarely used in US NICUs. Strategies to increase the study of safe and effective drugs for neonates are needed.

  1. Hazard Communication Standard for Chemical Labels and Safety Data Sheets In GHS Format

    EPA Pesticide Factsheets

    This fact sheet provides an overview of the required contents of Safety Data Sheets (SDSs) and chemical hazard labels, and includes tips on how these materials can be used to better protect health and the environment.

  2. Soil Fumigant Labels - Methyl Bromide

    EPA Pesticide Factsheets

    Search soil fumigant pesticide labels by EPA registration number, product name, or company, and follow the link to The Pesticide Product Label System (PPLS) for details. Updated labels include new safety requirements for buffer zones and related measures.

  3. Single-Dose Pharmacokinetics and Safety of Ziprasidone in Children and Adolescents

    ERIC Educational Resources Information Center

    Sallee, Floyd R.; Miceli, Jeffrey J.; Tensfeldt, Thomas; Robarge, Lisa; Wilner, Keith; Patel, Nick C.

    2006-01-01

    Objective: The purpose of this study was to provide single-dose pharmacokinetic, safety, and tolerability data for ziprasidone in youths with tic disorder, for comparison to adult studies to discern whether ziprasidone pediatric dosing could be modeled from adult data. Method: A single-dose, open-label study of ziprasidone was conducted in youths…

  4. [Comparative study of device labeling regulation in U.S.A. and China].

    PubMed

    Li, Fei; Wei, Jing; Ma, Yanbin; Li, Zhu

    2010-09-01

    To provide references for the evolvement of medical devices labeling and manual administration in China, By content analysis, 10 juristic documents relevant to device labeling and manual were collected from FDA website, compared to which, the federal regulation was mainly analyzed. There are five main differences of device labeling regulation between U.S.A. and China: juristic system, administrative scope, administrative target, characteristics and practice, A set of comprehensive juristic system for device labeling has been established by FDA. from which China should draw experience, to administrate the prescription devices and the over-the-counter devices in classification, and set up device labeling guidance, thus guarantee the safety and efficacy of device.

  5. PRN 84-1: Clarification of Label Improvement Program for Farmworker Safety and Pesticide Storage and Disposal Instructions

    EPA Pesticide Factsheets

    This PR notice clarifies EPA's intentions regarding the Pesticide Label Improvement Program for Farmworker Safety (PR Notice 83-2) and Pesticide Storage and Disposal Instructions (PR Notice 83-3) issued on March 26, 1983.

  6. Open-Label, Prospective Trial of Olanzapine in Adolescents with Subaverage Intelligence and Disruptive Behavioral Disorders

    ERIC Educational Resources Information Center

    Handen, Benjamin L.; Hardan, Antonio Y.

    2006-01-01

    Objective: Olanzapine, an atypical antipsychotic, has been shown to be efficacious for treatment of psychotic and mood disorders in adults. This prospective, open-label study was conducted to examine the safety and usefulness of olanzapine in treating disruptive behavior disorders in adolescents with subaverage intelligence. Method: Sixteen…

  7. Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness.

    PubMed

    Boyce, Richard D; Horn, John R; Hassanzadeh, Oktie; Waard, Anita de; Schneider, Jodi; Luciano, Joanne S; Rastegar-Mojarad, Majid; Liakata, Maria

    2013-01-26

    Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File - Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market.

  8. Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

    PubMed Central

    2013-01-01

    Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug’s efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File – Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market. PMID:23351881

  9. 29 CFR 1926.61 - Retention of DOT markings, placards and labels.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Section 1926.61 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Occupational Health and Environmental Controls § 1926.61 Retention of DOT markings, placards and labels. Note: The...

  10. 29 CFR 1926.61 - Retention of DOT markings, placards and labels.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Section 1926.61 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Occupational Health and Environmental Controls § 1926.61 Retention of DOT markings, placards and labels. Note: The...

  11. Soil Fumigant Labels - Dazomet

    EPA Pesticide Factsheets

    Updated labels include new safety requirements for buffer zones and related measures. Find information from the Pesticide Product Labeling System (PPLS) for products such as Basamid G, manufactured by Amvac.

  12. United States Food and Drug Administration Product Label Changes

    PubMed Central

    Sung, Julie C.; Stein-Gold, Linda; Goldenberg, Gary

    2017-01-01

    Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:28367259

  13. United States Food and Drug Administration Product Label Changes

    PubMed Central

    Sung, Julie C.; Stein-Gold, Linda; Goldenberg, Gary

    2016-01-01

    Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:26962391

  14. United States Food and Drug Administration Product Label Changes.

    PubMed

    Kircik, Leon; Sung, Julie C; Stein-Gold, Linda; Goldenberg, Gary

    2017-02-01

    Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug.

  15. 9 CFR 381.443 - Significant participation for voluntary nutrition labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... voluntary nutrition labeling. 381.443 Section 381.443 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 381.443 Significant participation for voluntary nutrition labeling. (a) In evaluating significant participation for voluntary nutrition labeling, FSIS will consider only the major cuts of single...

  16. 9 CFR 381.443 - Significant participation for voluntary nutrition labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... voluntary nutrition labeling. 381.443 Section 381.443 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 381.443 Significant participation for voluntary nutrition labeling. Link to an... 76890, Dec. 9, 2011. (a) In evaluating significant participation for voluntary nutrition labeling, FSIS...

  17. 9 CFR 317.343 - Significant participation for voluntary nutrition labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... voluntary nutrition labeling. 317.343 Section 317.343 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 317.343 Significant participation for voluntary nutrition labeling. Link to an... 76890, Dec. 9, 2011. (a) In evaluating significant participation for voluntary nutrition labeling, FSIS...

  18. 9 CFR 317.343 - Significant participation for voluntary nutrition labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... voluntary nutrition labeling. 317.343 Section 317.343 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 317.343 Significant participation for voluntary nutrition labeling. (a) In evaluating significant participation for voluntary nutrition labeling, FSIS will consider only the major cuts of single...

  19. An open-label six-month extension study to investigate the safety and efficacy of an extract of Artemisia annua for managing pain, stiffness and functional limitation associated with osteoarthritis of the hip and knee.

    PubMed

    Hunt, Sheena; Stebbings, Simon; McNamara, Debra

    2016-10-28

    This six-month single-centre open-label extension study, conducted at the University of Otago, Dunedin, follows from a previously published 12-week pilot double-blind randomised placebo-controlled study of dietary supplement, Arthrem® (ART) in patients with osteoarthritis (OA) of the hip or knee. The pilot double-blind study showed that treatment with ART 150 mg twice-daily was associated with clinically relevant pain reduction. The extension study aims were to assess longer-term safety and efficacy during six months' treatment following the pilot trial. Patients who completed the pilot double-blind study had the option to continue on open-label treatment with ART for a further six months. Safety was assessed by adverse event monitoring and laboratory tests at three and six months. Efficacy was assessed at three and six months using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®). Thirty-four patients entered the optional extension and 28 completed six months' treatment. ART was well tolerated when taken for up to nine months. Improvements in WOMAC® efficacy parameters reported in the double-blind phase of the study were maintained over six months. ART appears to be a safe and effective alternative for managing the symptoms of OA over an extended period.

  20. 49 CFR 583.5 - Label requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 7 2013-10-01 2013-10-01 false Label requirements. 583.5 Section 583.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.5 Label...

  1. 49 CFR 583.5 - Label requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Label requirements. 583.5 Section 583.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.5 Label...

  2. 49 CFR 583.5 - Label requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false Label requirements. 583.5 Section 583.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.5 Label...

  3. 49 CFR 583.5 - Label requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 7 2012-10-01 2012-10-01 false Label requirements. 583.5 Section 583.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.5 Label...

  4. 49 CFR 583.5 - Label requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 7 2014-10-01 2014-10-01 false Label requirements. 583.5 Section 583.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.5 Label...

  5. Drugs and Diseases Interacting with Cigarette Smoking in US Prescription Drug Labelling.

    PubMed

    Li, Haibo; Shi, Qiang

    2015-05-01

    The US Food and Drug Administration (FDA) draft guidance for industry on drug interaction studies recommends, but does not mandate, that both cigarette smokers and non-smokers can be used to study drug metabolism in clinical trials, and that important results related to smoking should be included in drug labelling to guide medication usage. This study aimed to provide a comprehensive review of drugs or diseases interacting with smoking, as presented in all US drug labelling. The 62,857 drug labels deposited in the FDA Online Label Repository were searched using the keywords 'smoke', 'smoker(s)', 'smoking', 'tobacco' and 'cigarette(s)' on 19 June 2014. The resultant records were refined to include only human prescription drug labelling, for manual examination. For 188 single-active-ingredient drugs and 36 multiple-active-ingredient drugs, the labelling was found to contain smoking-related information. The pharmacokinetics of 29 and 21 single-active-ingredient drugs were affected and unaffected, respectively, by smoking. For the remaining drugs, the provided information related to smoking affecting efficacy, safety or diseases but not pharmacokinetics. Depending on the nature of specific drugs, the perturbation in pharmacokinetic parameters in smokers ranged from 13 to 500%, in comparison with non-smokers. Dosage modifications in smokers are necessary for four drugs and may be necessary for six drugs, but are unnecessary for seven drugs although the pharmacokinetic parameters of four of them are affected by smoking. Cigarette smoking is a risk factor for 16 types of diseases or adverse drug reactions. For one single-active-ingredient contraceptive drug and 10 multiple-active-ingredient contraceptive drugs, a black box warning (the FDA's strongest safety warning) is included in the labelling for increased risks of heart attacks and strokes in female smokers, and "women are strongly advised not to smoke" when using these drugs. This study presents the first comprehensive overview of cigarette smoking interacting with drugs and/or diseases, as presented in US drug labelling.

  6. 9 CFR 317.343 - Significant participation for voluntary nutrition labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... voluntary nutrition labeling. 317.343 Section 317.343 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 317.343 Significant participation for voluntary nutrition labeling. Link to an... nutrition labeling, FSIS will consider only the major cuts of single-ingredient, raw meat products, as...

  7. 9 CFR 381.443 - Significant participation for voluntary nutrition labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... voluntary nutrition labeling. 381.443 Section 381.443 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 381.443 Significant participation for voluntary nutrition labeling. Link to an... nutrition labeling, FSIS will consider only the major cuts of single-ingredient, raw poultry products, as...

  8. 29 CFR 1915.100 - Retention of DOT markings, placards and labels.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Section 1915.100 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) OCCUPATIONAL SAFETY AND HEALTH STANDARDS FOR SHIPYARD EMPLOYMENT General Working Conditions § 1915.100 Retention of DOT markings, placards and labels. (a) Any employer who...

  9. 48 CFR 252.223-7001 - Hazard warning labels.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Hazardous Material Identification and Material Safety Data clause of this contract. (b) The Contractor shall label the item package (unit container) of any hazardous material to be delivered under this contract in... which hazardous material listed in the Hazardous Material Identification and Material Safety Data clause...

  10. 48 CFR 252.223-7001 - Hazard warning labels.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Hazardous Material Identification and Material Safety Data clause of this contract. (b) The Contractor shall label the item package (unit container) of any hazardous material to be delivered under this contract in... which hazardous material listed in the Hazardous Material Identification and Material Safety Data clause...

  11. 48 CFR 252.223-7001 - Hazard warning labels.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Hazardous Material Identification and Material Safety Data clause of this contract. (b) The Contractor shall label the item package (unit container) of any hazardous material to be delivered under this contract in... which hazardous material listed in the Hazardous Material Identification and Material Safety Data clause...

  12. 48 CFR 252.223-7001 - Hazard warning labels.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Hazardous Material Identification and Material Safety Data clause of this contract. (b) The Contractor shall label the item package (unit container) of any hazardous material to be delivered under this contract in... which hazardous material listed in the Hazardous Material Identification and Material Safety Data clause...

  13. 48 CFR 252.223-7001 - Hazard warning labels.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Hazardous Material Identification and Material Safety Data clause of this contract. (b) The Contractor shall label the item package (unit container) of any hazardous material to be delivered under this contract in... which hazardous material listed in the Hazardous Material Identification and Material Safety Data clause...

  14. 30 CFR 47.42 - Label contents.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Label contents. 47.42 Section 47.42 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.42 Label contents. When an operator must make a label, the label must— (a) Be...

  15. 30 CFR 47.42 - Label contents.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Label contents. 47.42 Section 47.42 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.42 Label contents. When an operator must make a label, the label must— (a) Be...

  16. 30 CFR 47.42 - Label contents.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Label contents. 47.42 Section 47.42 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.42 Label contents. When an operator must make a label, the label must— (a) Be...

  17. 30 CFR 47.42 - Label contents.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Label contents. 47.42 Section 47.42 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.42 Label contents. When an operator must make a label, the label must— (a) Be...

  18. 30 CFR 47.42 - Label contents.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Label contents. 47.42 Section 47.42 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.42 Label contents. When an operator must make a label, the label must— (a) Be...

  19. Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome.

    PubMed

    Inoue, Yuichi; Hirata, Koichi; Hayashida, Kenichi; Hattori, Nobutaka; Tomida, Takayuki; Garcia-Borreguero, Diego

    2013-01-10

    The present study aimed to examine the long-term efficacy and safety of rotigotine treatment for restless legs syndrome (RLS), as well as the rate of clinically significant augmentation, in a 1-year open-label study of Japanese subjects. Japanese patients with RLS who had been treated with rotigotine or placebo in a double-blind trial were enrolled in a 1-year, open-label, uncontrolled extension study and treated with rotigotine at a dose of up to 3 mg/24 h after an 8-week titration phase. Outcomes included International Restless Legs Syndrome Study Group rating scale (IRLS scale), Pittsburgh Sleep Quality Index (PSQI), safety, and investigator-/expert panel-assessed augmentation (including Augmentation Severity Rating Scale). Overall, 185 patients entered the open-label study and 133 completed the study. IRLS and PSQI total scores improved throughout the 52-week treatment period (IRLS, from 23.2±5.1 to 7.8±7.6 and PSQI, from 8.0±3.1 to 5.0±2.9). Treatment-emergent adverse events were mild to moderate in severity, and included application site reactions (52.4%) and nausea (28.6%). Clinically significant augmentation occurred in five patients (2.7%). These results indicate a good long-term efficacy of rotigotine for treating RLS, with a relatively low risk of clinically significant augmentation. Copyright © 2012 Elsevier Inc. All rights reserved.

  20. STX209 (Arbaclofen) for Autism Spectrum Disorders: An 8-Week Open-Label Study

    ERIC Educational Resources Information Center

    Erickson, Craig A.; Veenstra-Vanderweele, Jeremy M.; Melmed, Raun D.; McCracken, James T.; Ginsberg, Lawrence D.; Sikich, Linmarie; Scahill, Lawrence; Cherubini, Maryann; Zarevics, Peter; Walton-Bowen, Karen; Carpenter, Randall L.; Bear, Mark F.; Wang, Paul P.; King, Bryan H.

    2014-01-01

    STX209 (arbaclofen), a selective GABA-B agonist, is hypothesized to modulate the balance of excitatory to inhibitory neurotransmission, and has shown preliminary evidence of benefit in fragile X syndrome. We evaluated its safety, tolerability, and efficacy in non-syndromic autism spectrum disorders, in an 8-week open-label trial enrolling 32…

  1. 29 CFR 1910.1201 - Retention of DOT markings, placards and labels.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 6 2011-07-01 2011-07-01 false Retention of DOT markings, placards and labels. 1910.1201 Section 1910.1201 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) OCCUPATIONAL SAFETY AND HEALTH STANDARDS (CONTINUED) Toxic and...

  2. 29 CFR 1915.92 - Retention of DOT markings, placards, and labels.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 7 2013-07-01 2013-07-01 false Retention of DOT markings, placards, and labels. 1915.92 Section 1915.92 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) OCCUPATIONAL SAFETY AND HEALTH STANDARDS FOR SHIPYARD EMPLOYMENT...

  3. 29 CFR 1910.1201 - Retention of DOT markings, placards and labels.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 6 2014-07-01 2013-07-01 true Retention of DOT markings, placards and labels. 1910.1201 Section 1910.1201 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) OCCUPATIONAL SAFETY AND HEALTH STANDARDS (CONTINUED) Toxic and...

  4. PRN 2012-1: Material Safety Data Sheets as Pesticide Labeling

    EPA Pesticide Factsheets

    This Notice updates and clarifies EPA’s determination in PRN 92-4 that a Material Safety Data Sheet that accompanies a pesticide product is considered part of the pesticide’s labeling but does not need EPA approval if it is consistent with 40CFR Part 156.

  5. Safety warnings and first aid instructions on consumer and pharmaceutical products in Nigeria: has there been an improvement?

    PubMed

    Nonyelum, Stanley Catherine; Nkem, Nwachukwu; Ifeyinwa, Chijoke-Nwauche; Orisakwe, Orish Ebere

    2010-10-01

    To investigate the adequacy of safety warnings and first aid instructions on the labels of pharmaceutical and consumer products in Nigeria. A market basket method (total collection of all available samples) was used to investigate the adequacy of safety warnings and first aid instructions on the labels of 600 pharmaceutical and consumer products in Nigeria. The results showed that 69.8% of the products had adequate warnings whereas 385 (64.1%) of the products screened had legible product warnings. Only 52 (8.7%) of the total number of products had appropriate first aid instructions while only 25 (4.12%) of the products described symptoms and full treatment of poisoning by the product and 319 (53.2%) products surveyed recommended calling a health professional. A total of 31 (5.2%) products had labels that were considered too technical (non English). Of the 600 products, 386 (64.3%) had dosage instructions that were considered adequate while 538 (89.6%) had adequate storage instructions. About 68% of the products had partially correct warnings while 44 or 7.3% had partially correct first aid instructions. Some products had neither warnings nor first aid instructions. This study suggests a not too impressive improvement in the correctness and appropriateness of label information.

  6. Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open-label studies.

    PubMed

    Belkoff, L; Brock, G; Carrara, D; Neijber, A; Ando, M; Mitchel, J

    2018-02-01

    Efficacy and safety of testosterone gel 2% (TG) were evaluated in two phase 3, open-labelled, single-arm, multicentre studies (000023 and extension study 000077). Hypogonadal men having serum testosterone levels <300 ng/dl at two consecutive measurements were included. Study duration was 9 months (000023: 3 months; 000077: 6 months). Starting dose of TG (46 mg) was applied on upper arm/shoulder. The primary endpoint (000023) was responder rate (subjects with average 24-hour serum testosterone concentration 300-1050 ng/dl on Day 90). Study 000077 evaluated the safety of TG in patients rolling over from study 000023 over a period of 6 months. Of 180 subjects in 000023, 172 completed and 145 rolled over to 000077, with 127 completers. The responder rate was 85.5%. Fewer subjects in 000077 (12.7%) versus 000023 (31.8%) had maximum testosterone concentration (C max ) >1500 ng/dl, with no significant safety concerns. Significant improvements in sexual function and quality of life were noted in both studies. Subjects experienced few skin reactions without notable increases in prostate-specific antigen and haematocrit levels. TG was efficacious with an acceptable safety profile. C max >1500 ng/dl did not exhibit distinct impact on safety parameters. However, further optimisation of titration schema to reduce C max is warranted while maintaining the average steady state total testosterone concentration. © 2017 Blackwell Verlag GmbH.

  7. Drug Labeling and Exposure in Neonates

    PubMed Central

    Laughon, Matthew M.; Avant, Debbie; Tripathi, Nidhi; Hornik, Christoph P.; Cohen-Wolkowiez, Michael; Clark, Reese H.; Smith, P. Brian; Rodriguez, William

    2014-01-01

    Importance Federal legislation has led to a notable increase in pediatric studies submitted to the Food and Drug Administration (FDA), resulting in new pediatric information in product labeling. However, approximately 50% of drug labels still have insufficient information on safety, efficacy, or dosing in children. Neonatal information in labeling is even scarcer because neonates comprise a vulnerable subpopulation for which end point development is lagging and studies are more challenging. Objective To quantify progress made in neonatal studies and neonatal information in product labeling as result of recent legislation. Design 1. Cohort of neonatal drug studies; and 2. Cohort of infants exposed to these drugs.. Setting 1. Neonatal drug studies: FDA website; 2. National review: infants admitted to a neonatal intensive care unit (NICU) Participants 1) We identified drug studies between 1997 and 2010 that included neonates as a result of pediatric legislation using information available on the FDA website. We determined what studies were published in the medical literature, the legislation responsible for the studies, and the resulting neonatal labeling changes. 2) We then examined the use of these drugs in neonates admitted to 290 NICUs (the Pediatrix Data Warehouse) in the United States from 2005–2010. Exposures Infants exposed to a drug studied in neonates as identified by the FDA website Main outcome measures Number of drug studies with neonates and rate of exposure per 1000 admission among infants admitted to a NICU Results In a review of the FDA databases, we identified 28 drugs studied in neonates and 24 related labeling changes. Forty-one studies encompassed the 28 drugs, and 31 (76%) of these were published. Eleven (46%) of the 24 neonatal labeling changes established safety and effectiveness. In a review of a cohort of 446,335 hospitalized infants, we identified 399 drugs used and 1,525,739 drug exposures in the first 28 postnatal days. Thirteen (46%) of the 28 drugs studied in neonates were not used in NICUs; 8 (29%) were used in fewer than 60 neonates. Of the drugs studied, ranitidine was used most often (15,627 neonates, 35 exposures per 1000 admissions). Conclusions and Relevance Few drug labeling changes made under pediatric legislation include neonates. Most drugs studied are either not used or rarely used in U.S. NICUs. Strategies to increase the study of safe and effective drugs for neonates are needed. PMID:24322269

  8. Safety, Tolerability, and Efficacy of Quetiapine in Youth with Schizophrenia or Bipolar I Disorder: A 26-Week, Open-Label, Continuation Study

    PubMed Central

    Pathak, Sanjeev; Earley, Willie R.; Liu, Sherry; DelBello, Melissa

    2013-01-01

    Abstract Objective The purpose of this study was to describe the safety, tolerability, and efficacy of quetiapine monotherapy continued for up to 26-weeks in youth with schizophrenia or bipolar I disorder. Methods Medically healthy boys and girls with a baseline Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV-TR) diagnosis of schizophrenia (ages 13–17 years) or a manic episode of bipolar I disorder (ages 10–17 years) who participated in one of two acute, double-blind, placebo-controlled studies of immediate-release quetiapine were potentially eligible to enroll in a 26-week, open-label study. During the open-label study, quetiapine was flexibly dosed at 400–800 mg/day, with options to reduce dosing to 200 mg/day based on tolerability. Safety and tolerability outcomes assessed from open-label baseline to week 26 included adverse events (AEs), metabolic/laboratory parameters, extrapyramidal symptoms, suicidality, and vital signs. Results Of 381 patients enrolled in the open-label study (n=176, schizophrenia; n=205, bipolar disorder diagnosis), 237 patients (62.2%) completed the 26-week study period (71.0%, schizophrenia; 54.6%, bipolar disorder). The most common AEs reported during the study included somnolence, headache, sedation, weight increase, and vomiting. A total of 14.9% of patients experienced a shift to potentially clinically significant low levels of high-density lipoprotein cholesterol and 10.2% of patients experienced a shift to potentially clinically significant high triglyceride levels. Weight gain ≥7% was reported in 35.6% of patients between open-label baseline and final visit. After adjustment for normal growth, 18.3% of study participants experienced clinically significant weight gain (i.e., increase in body mass index ≥0.5 standard deviations from baseline). Conclusions In this 26-week study, quetiapine flexibly dosed at 400–800 mg/day, with options to reduce dosing based on tolerability, was generally safe and well tolerated in youth. Clinicians should monitor lipid profiles and weight gain in youth with schizophrenia or bipolar disorder during treatment with quetiapine. Clinical trial registration information Quetiapine Fumarate (Seroquel) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder (ANCHOR 150). Available at: http://clinicaltrials.gov/ct2/show/NCT00227305 PMID:24024534

  9. Drug safety: Pregnancy rating classifications and controversies.

    PubMed

    Wilmer, Erin; Chai, Sandy; Kroumpouzos, George

    2016-01-01

    This contribution consolidates data on international pregnancy rating classifications, including the former US Food and Drug Administration (FDA), Swedish, and Australian classification systems, as well as the evidence-based medicine system, and discusses discrepancies among them. It reviews the new Pregnancy and Lactation Labeling Rule (PLLR) that replaced the former FDA labeling system with narrative-based labeling requirements. PLLR emphasizes on human data and highlights pregnancy exposure registry information. In this context, the review discusses important data on the safety of most medications used in the management of skin disease in pregnancy. There are also discussions of controversies relevant to the safety of certain dermatologic medications during gestation. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Soil Fumigant Labels - Metam Sodium/Potassium

    EPA Pesticide Factsheets

    Search by EPA registration number, product name, or company; and follow the link to the Pesticide Product Label System (PPLS) for details. Updated labels include new safety requirements for buffer zones and related measures.

  11. EPA Extends Comment Period for Draft Label Revisions on Respirators

    EPA Pesticide Factsheets

    Extending Comment Period for Draft Label Revisions on Respirators, Bring the respirator descriptions on pesticide labels into conformance with the current National Institute for Occupational Safety and Health (NIOSH) respirator language

  12. Managing uncertainty about food risks - Consumer use of food labelling.

    PubMed

    Tonkin, Emma; Coveney, John; Meyer, Samantha B; Wilson, Annabelle M; Webb, Trevor

    2016-12-01

    General consumer knowledge of and engagement with the production of food has declined resulting in increasing consumer uncertainty about, and sensitivity to, food risks. Emphasis is therefore placed on providing information for consumers to reduce information asymmetry regarding food risks, particularly through food labelling. This study examines the role of food labelling in influencing consumer perceptions of food risks. In-depth, 1-h interviews were conducted with 24 Australian consumers. Participants were recruited based on an a priori defined food safety risk scale, and to achieve a diversity of demographic characteristics. The methodological approach used, adaptive theory, was chosen to enable a constant interweaving of theoretical understandings and empirical data throughout the study. Participants discussed perceiving both traditional (food spoilage/microbial contamination) and modern (social issues, pesticide and 'chemical' contamination) risks as present in the food system. Food labelling was a symbol of the food system having managed traditional risks, and a tool for consumers to personally manage perceived modern risks. However, labelling also raised awareness of modern risks not previously considered. The consumer framing of risk presented demonstrates the need for more meaningful consumer engagement in policy decision making to ensure risk communication and management meet public expectations. This research innovatively identifies food labelling as both a symbol of, and a tool for, the management of perceived risks for consumers. Therefore it is imperative that food system actors ensure the authenticity and trustworthiness of all aspects of food labelling, not only those related to food safety. Copyright © 2016 Elsevier Ltd. All rights reserved.

  13. Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis.

    PubMed

    Genovese, Mark C; van Vollenhoven, Ronald F; Wilkinson, Bethanie; Wang, Lisy; Zwillich, Samuel H; Gruben, David; Biswas, Pinaki; Riese, Richard; Takiya, Liza; Jones, Thomas V

    2016-06-23

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). The aim of this study was to explore the safety and efficacy of open-label tofacitinib following blinded treatment with adalimumab or tofacitinib for moderate to severe RA. Analyses included patients treated with adalimumab 40 mg once every 2 weeks or tofacitinib 10 mg twice daily (BID) with background methotrexate (MTX) in a 12-month randomized study (NCT00853385), who subsequently received tofacitinib 10 mg BID (with/without background MTX) in an open-label extension (NCT00413699). Patients with treatment-related serious adverse events (AEs) and serious or recurrent infections in the index study were excluded from the extension study. Exposure-adjusted incidence rates of safety-related events were assessed in 3-month and 12-month periods in the year before and in the year after switching. Efficacy was assessed 3 months before, at the time of, and 3 months after switching. There were 233 (107 adalimumab to tofacitinib 10 mg BID, 126 blinded to open-label tofacitinib 10 mg BID) patients included in these analyses. Patients in both treatment sequences had similar incidence rates (per 100 patient-years) of discontinuation due to AEs, serious AEs, and serious infections in the year before and in the year after switching. Incidence rates of AEs were increased in the first 3 months after switching compared with the last 3 months before switching in both treatment groups. Switching from either blinded adalimumab or tofacitinib to open-label tofacitinib resulted in numerically higher incidence of responders for signs and symptoms of disease and improved physical function. Treatment can be directly switched from adalimumab to tofacitinib. A similar safety and efficacy profile was seen when patients received open-label tofacitinib after receiving either blinded adalimumab or tofacitinib. ClinicalTrials.gov Identifiers: NCT00853385 , registered 27 February 2009; NCT00413699 , registered 18 December 2006.

  14. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  15. 16 CFR 1211.24 - Product certification and labeling by manufacturers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by manufacturers. 1211.24 Section 1211.24 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT... § 1211.24 Product certification and labeling by manufacturers. (a) Form of permanent label of...

  16. Soil Fumigant Labels - Chloropicrin

    EPA Pesticide Factsheets

    Search by EPA registration number, product name, or company name, and follow the link to the Pesticide Product Label System (PPLS) for details on each fumigant. Updated labels include new safety requirements for buffer zones and related measures.

  17. Safety and feasibility of breast lesion localization using magnetic seeds (Magseed): a multi-centre, open-label cohort study.

    PubMed

    Harvey, James R; Lim, Yit; Murphy, John; Howe, Miles; Morris, Julie; Goyal, Amit; Maxwell, Anthony J

    2018-06-01

    Wire localization has several disadvantages, notably wire migration and difficulty scheduling the procedure close to surgery. Radioactive seed localization overcomes these disadvantages, but implementation is limited due to radiation safety requirements. Magnetic seeds potentially offer the logistical benefits and transcutaneous detection equivalence of a radioactive seed, with easier implementation. This study was designed to evaluate the feasibility and safety of using magnetic seeds for breast lesion localization. A two-centre open-label cohort study to assess the feasibility and safety of magnetic seed (Magseed) localization of breast lesions. Magseeds were placed under radiological guidance into women having total mastectomy surgery. The primary outcome measure was seed migration distance. Secondary outcome measures included accuracy of placement, ease of transcutaneous detection, seed integrity and safety. Twenty-nine Magseeds were placed into the breasts of 28 patients under ultrasound guidance. There was no migration of the seeds between placement and surgery. Twenty-seven seeds were placed directly in the target lesion with the other seeds being 2 and 3 mm away. All seeds were detectable transcutaneously in all breast sizes and at all depths. There were no complications or safety issues. Magnetic seeds are a feasible and safe method of breast lesion localization. They can be accurately placed, demonstrate no migration in this feasibility study and are detectable in all sizes and depths of breast tissue. Now that safety and feasibility have been demonstrated, further clinical studies are required to evaluate the seed's effectiveness in wide local excision surgery.

  18. Safety and Durability of Effect with Long-Term, Open-Label Droxidopa Treatment in Patients with Symptomatic Neurogenic Orthostatic Hypotension (NOH303).

    PubMed

    Isaacson, Stuart; Shill, Holly A; Vernino, Steven; Ziemann, Adam; Rowse, Gerald J

    2016-10-19

    Neurogenic orthostatic hypotension (nOH) is associated with insufficient norepinephrine release in response to postural change. The objective of this study was to evaluate the long-term safety and durability of efficacy of the norepinephrine precursor droxidopa in patients with symptomatic nOH. This multinational study consisted of 3 sequential phases: a 3-month open-label droxidopa treatment phase followed by a 2-week double-blind, placebo-controlled withdrawal phase, and a 9-month open-label extension phase in which all patients received droxidopa. Patients were adults diagnosed with symptomatic nOH associated with Parkinson's disease, multiple system atrophy, pure autonomic failure, dopamine β-hydroxylase deficiency, or nondiabetic autonomic neuropathy. Efficacy was evaluated using patient- and investigator-reported questionnaire responses and the orthostatic standing test. Safety was assessed through adverse event (AE) reports and vital signs. A total of 102 patients received treatment with droxidopa. Initial improvements from baseline in patient-reported nOH symptom severity and impact on daily activities, evaluated using the Orthostatic Hypotension Questionnaire, exceeded 50% and were maintained throughout the 12-month study. Decreased nOH severity was also reflected in clinician and patient ratings on the Clinical Global Impression questionnaire. Standing systolic and diastolic blood pressures were increased from baseline throughout the study with droxidopa treatment. The most frequently reported AEs were falls, urinary tract infection, and headache. There was a low incidence (≤2%) of cardiac AEs (eg, first-degree atrioventricular block, supraventricular extrasystoles). Long-term, open-label treatment with droxidopa for up to 12 months was generally well tolerated and provided durable improvements in nOH signs and symptoms.

  19. 33 CFR 183.514 - Fuel tanks: Labels.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Fuel tanks: Labels. 183.514...) BOATING SAFETY BOATS AND ASSOCIATED EQUIPMENT Fuel Systems Equipment Standards § 183.514 Fuel tanks: Labels. (a) Each fuel tank must have a label that meets the requirements of paragraphs (b) through (d) of...

  20. 33 CFR 183.514 - Fuel tanks: Labels.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Fuel tanks: Labels. 183.514...) BOATING SAFETY BOATS AND ASSOCIATED EQUIPMENT Fuel Systems Equipment Standards § 183.514 Fuel tanks: Labels. (a) Each fuel tank must have a label that meets the requirements of paragraphs (b) through (d) of...

  1. Car Seat Safety

    MedlinePlus

    ... Staying Safe Videos for Educators Search English Español Car Seat Safety KidsHealth / For Parents / Car Seat Safety ... certified child passenger safety technician.) Guidelines for Choosing Car Seats Choose a seat with a label that ...

  2. 49 CFR 1.50 - Delegation to the National Highway Traffic Safety Administrator.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... program; (9) Section 2010, motorcyclist safety; (10) Section 2011, child safety and child booster seat... use technologies; (24) Section 10307(b), regulations, in regard to safety labeling requirements; (25...

  3. 49 CFR 1.50 - Delegation to the National Highway Traffic Safety Administrator.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... program; (9) Section 2010, motorcyclist safety; (10) Section 2011, child safety and child booster seat... use technologies; (24) Section 10307(b), regulations, in regard to safety labeling requirements; (25...

  4. 16 CFR 1402.4 - Requirements to provide performance and technical data by labeling and instructions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS CB BASE STATION ANTENNAS, TV ANTENNAS, AND... instructions. (a) Notice to purchasers. Manufacturers of CB base station antennas, TV antennas, and antenna... base station antennas and TV antennas shall be provided with the following: EC03OC91.048 (i) Label. (A...

  5. 78 FR 45930 - Guidance for Industry: Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-30

    ...] Guidance for Industry: Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51...

  6. Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD

    ERIC Educational Resources Information Center

    Adler, Lenard A.; Spencer, Thomas; McGough, James J.; Jiang, Hai; Muniz, Rafael

    2009-01-01

    Objective: This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD. Method: Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness…

  7. Proceedings: Workshop on Environmental Considerations in the Life-Cycle of Paints and Coatings Held in Champaign, Illinois on September 9-10, 1986

    DTIC Science & Technology

    1988-07-01

    MSDS or Material Safety Data Sheets from our suppliers and we are required to provide the same for our customers . We are required to train our personnel...non-sparking tools. Labels We protect our customers by labeling our materials in accordance with the NPCA Labeling Guide which is at least as...stringent as any federal or local regulations, by providing Material Safety Data Sheets and by providing customer assistance O when requested regarding safe

  8. Figuring Out Food Labels (For Kids)

    MedlinePlus

    ... First Aid & Safety Doctors & Hospitals Videos Recipes for Kids Kids site Sitio para niños How the Body Works ... English Español Figuring Out Food Labels KidsHealth / For Kids / Figuring Out Food Labels What's in this article? ...

  9. No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a Phase I Open Label Study to assess safety, tolerability and cytokine responses

    USDA-ARS?s Scientific Manuscript database

    Although Lactobacillus rhamnosus GG ATCC 53103 (LGG) has been consumed since the mid 1990s by between 2 and 5 million people daily, the scientific literature lacks rigorous clinical trials that describe the potential harms of LGG, particularly in the elderly. The primary objective of this open label...

  10. 9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...

  11. 9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...

  12. 9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...

  13. 9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...

  14. 9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...

  15. 9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...

  16. 9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...

  17. 9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...

  18. 33 CFR 181.17 - Label numbers and letters.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Label numbers and letters. 181.17...) BOATING SAFETY MANUFACTURER REQUIREMENTS Manufacturer Certification of Compliance § 181.17 Label numbers and letters. Letters and numbers on each label must: (a) Be no less than one-eighth of an inch in...

  19. 33 CFR 181.17 - Label numbers and letters.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Label numbers and letters. 181.17...) BOATING SAFETY MANUFACTURER REQUIREMENTS Manufacturer Certification of Compliance § 181.17 Label numbers and letters. Letters and numbers on each label must: (a) Be no less than one-eighth of an inch in...

  20. Targeted radionuclide therapy for lung cancer with iodine-131-labeled peptide in a nude-mouse model.

    PubMed

    Chen, Zhenzhu; Gao, Hongyi; Li, Man; Fang, Shun; Li, Guiping; Guo, Linlang

    2017-06-01

    Integrin α3β1 has been shown to be a novel candidate target for the imaging and specific therapy of non-small-cell lung cancer. We have previously reported on a peptide containing a novel motif of NGXG that specifically binds to the integrin α3 receptor on lung cancer cells using a one-bead one-peptide combinatorial library. In this study, we developed the peptide cNGEGQQc-based therapeutic agent labeling with radionuclide iodine-131 (I) and evaluated its characteristics including stability, biodistribution, antitumor activity, and safety. The results showed that I-cNGEGQQc was stable in serum. Furthermore, the biodistribution of I-cNGEGQQc was determined in normal mice and rabbits. In-vivo biodistribution studies showed that radiolabeled peptide in the kidney was significantly higher than that in other organs. Nude mice bearing lung cancer cell xenografts (H1975 and L78) were used as an in-vivo model for tumor-inhibition efficacy studies with I-cNGEGQQc. The tumor growth decreased significantly in mice receiving I-labeled peptide compared with the controls and the effect of I-labeled peptide can be blocked by unlabeled cNGEGQQc. Safety studies showed that I-cNGEGQQc was relatively safe for animals without significant toxicity. Our data suggest that I-cNGEGQQc has potential as a targeted radiotherapeutic agent for non-small-cell lung cancer.

  1. An open-label pilot study to assess the efficacy and safety of virgin coconut oil in reducing visceral adiposity.

    PubMed

    Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G

    2011-01-01

    Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans.

  2. An Open-Label Pilot Study to Assess the Efficacy and Safety of Virgin Coconut Oil in Reducing Visceral Adiposity

    PubMed Central

    Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G.

    2011-01-01

    Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans. PMID:22164340

  3. Brexanolone as adjunctive therapy in super‐refractory status epilepticus

    PubMed Central

    Claassen, Jan; Wainwright, Mark S.; Husain, Aatif M.; Vaitkevicius, Henrikas; Raines, Shane; Hoffmann, Ethan; Colquhoun, Helen; Doherty, James J.; Kanes, Stephen J.

    2017-01-01

    Objective Super‐refractory status epilepticus (SRSE) is a life‐threatening form of status epilepticus that continues or recurs despite 24 hours or more of anesthetic treatment. We conducted a multicenter, phase 1/2 study in SRSE patients to evaluate the safety and tolerability of brexanolone (USAN; formerly SAGE‐547 Injection), a proprietary, aqueous formulation of the neuroactive steroid, allopregnanolone. Secondary objectives included pharmacokinetic assessment and open‐label evaluation of brexanolone response during and after anesthetic third‐line agent (TLA) weaning. Methods Patients receiving TLAs for SRSE control were eligible for open‐label, 1‐hour brexanolone loading infusions, followed by maintenance infusion. After 48 hours of brexanolone infusion, TLAs were weaned during brexanolone maintenance. After 4 days, the brexanolone dose was tapered. Safety and functional status were assessed over 3 weeks of follow‐up. Results Twenty‐five patients received open‐label study drug. No serious adverse events (SAEs) were attributable to study drug, as determined by the Safety Review Committee. Sixteen patients (64%) experienced ≥1 SAE. Six patient deaths occurred, all deemed related to underlying medical conditions. Twenty‐two patients underwent ≥1 TLA wean attempt. Seventeen (77%) met the response endpoint of weaning successfully off TLAs before tapering brexanolone. Sixteen (73%) were successfully weaned off TLAs within 5 days of initiating brexanolone infusion without anesthetic agent reinstatement in the following 24 hours. Interpretation In an open‐label cohort of limited size, brexanolone demonstrated tolerability among SRSE patients of heterogeneous etiologies and was associated with a high rate of successful TLA weaning. The results suggest the possible development of brexanolone as an adjunctive therapy for SRSE requiring pharmacological coma for seizure control. Ann Neurol 2017;82:342–352 PMID:28779545

  4. Long-term safety and tolerability of once-daily mesalamine granules in the maintenance of remission of ulcerative colitis.

    PubMed

    Lichtenstein, Gary R; Barrett, Andrew C; Bortey, Enoch; Paterson, Craig; Forbes, William P

    2014-08-01

    Ulcerative colitis (UC), a chronic, relapsing, and remitting inflammatory bowel disease, requires long-term treatment to maintain remission. In this study, the long-term safety and tolerability of mesalamine granules (MG) therapy was evaluated in the maintenance of UC remission. Previous prospective studies evaluating different oral mesalamine formulations have not exceeded a duration of 14 months. A phase 3, multicenter, 24-month, open-label extension study evaluating MG 1.5 g once daily in patients who achieved previous remission from mild to moderate UC was performed. Eligible patients had successfully participated in 1 of 2 previous 6-month double-blind, placebo-controlled trials or were new patients in remission. Safety assessments included monitoring of adverse events (AEs) and clinical laboratory tests. Risk of UC recurrence was assessed by the occurrence of UC-related AEs. Of the 393 patients enrolled (280 from the double-blind studies; 113 new patients), 388 were included in the safety population. The most common AEs included nasopharyngitis (13.9%), headache (11.6%), and diarrhea (10.8%), and the incidence of these events was generally lower in the MG group versus historical placebo group from the double-blind studies. Pancreatic, renal, and hepatic AEs occurred in 23 patients (5.9%). The risk of UC-related AEs was low and was maintained for 24 months during the open-label study. Once-daily MG has a favorable safety profile for the maintenance of remission for up to 2 years in patients with UC.

  5. Long-term Safety and Efficacy of Tapentadol Extended Release Following up to 2 Years of Treatment in Patients With Moderate to Severe, Chronic Pain: Results of an Open-label Extension Trial.

    PubMed

    Buynak, Robert; Rappaport, Stephen A; Rod, Kevin; Arsenault, Pierre; Heisig, Fabian; Rauschkolb, Christine; Etropolski, Mila

    2015-11-01

    Tapentadol extended release (ER) has demonstrated efficacy and safety for the management of moderate to severe, chronic pain in adults. This study evaluated the long-term safety and tolerability of tapentadol ER in patients with chronic osteoarthritis or low back pain. Patients were enrolled in this 1-year, open-label extension study after completing one of two 15-week, placebo-controlled studies of tapentadol ER and oxycodone controlled release (CR) for osteoarthritis knee pain (NCT00421928) or low back pain (NCT00449176), a 7-week crossover study between tapentadol immediate release and tapentadol ER for low back pain (NCT00594516), or a 1-year safety study of tapentadol ER and oxycodone CR for osteoarthritis or low back pain (NCT00361504). After titrating the drug to an optimal dose, patients received tapentadol ER (100-250 mg BID) for up to 1 year (after finishing treatment in the preceding studies); patients who were previously treated with tapentadol ER in the 1-year safety study received tapentadol ER continuously for up to 2 years in total. Of the 1,154 patients in the safety population, 82.7% were aged >65 years and 57.9% were female; 50.1% had mild baseline pain intensity. Mean (SD) pain intensity scores (11-point numerical rating scale) were 3.9 (2.38) at baseline (end of preceding study) and 3.7 (2.42) at end point, indicating that pain relief was maintained during the extension study. Improvements in measures of quality of life (eg, EuroQol-5 Dimension and the 36-item Short Form Health Survey [SF-36]) health status questionnaires) achieved during the preceding studies were maintained during the open-label extension study. Tapentadol ER was associated with a safety and tolerability profile comparable to that observed in the preceding studies. The most common treatment-emergent adverse events (incidence ≥10%; n = 1154) were headache (13.1%), nausea (11.8%), and constipation (11.1%). Similar efficacy and tolerability results were shown for patients who received up to 2 years of tapentadol ER treatment. Pain relief and improvements in quality of life achieved during the preceding studies were maintained throughout this extension study, during which tapentadol ER was well tolerated for the long-term treatment of chronic osteoarthritis or low back pain over up to 2 years of treatment. (ClinicalTrials.gov identifier: NCT00487435.). Copyright © 2015. Published by Elsevier Inc.

  6. Microbial status and product labelling of 58 original tattoo inks.

    PubMed

    Høgsberg, T; Saunte, D M; Frimodt-Møller, N; Serup, J

    2013-01-01

    European Council resolutions on tattoo ink introduce sterility and preservation of inks to protect customers. Inks used in Denmark are typically purchased over the internet from international suppliers and manufacturers from the US and the UK. In Denmark tattoo inks are regulated and labelled according to REACH as if they were plain chemicals. The objective of this study was to check the microbial product safety of unopened and opened tattoo ink stock bottles. Packaging, labelling, preservation, sterility and contamination with micro-organisms were studied. Physical inspection and culture of bacteria and fungi. Six of 58 unopened stock bottles (10%) were contaminated with bacteria and one of six samples (17%) of previously used stock bottles was contaminated. The bacterial species represented bacteria considered pathogenic in humans as well as non-pathogenic environmental bacteria. Yeast or moulds were detected in none of the samples. A total of 31% of the manufacturers informed only about the brand name. No information about content, sterility, risks or expiry date was indicated on the label. A total of 42% claimed sterility of their inks. A total of 54% labelled a maximum period of durability of typically 2-3 years. The physical sealing was leaking in 28% of the products. The European Council resolutions regarding safety of tattoo inks are not effective. Stock bottles of tattoo ink may contain bacteria pathogenic to humans and environmental bacteria, and packaging, labelling and preservation of inks are of inadequate quality. Claim of sterility can be erroneous. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

  7. 16 CFR 1500.133 - Extremely flammable contact adhesives; labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Extremely flammable contact adhesives; labeling. 1500.133 Section 1500.133 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.133 Extremely flammable contact adhesives; labeling. (a) Extremely flammable contact...

  8. 16 CFR 1500.125 - Labeling requirements for accompanying literature.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Labeling requirements for accompanying literature. 1500.125 Section 1500.125 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.125 Labeling requirements for accompanying literature. When any accompanying literature...

  9. 16 CFR 1500.125 - Labeling requirements for accompanying literature.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Labeling requirements for accompanying literature. 1500.125 Section 1500.125 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.125 Labeling requirements for accompanying literature. When any accompanying literature...

  10. 16 CFR 1500.125 - Labeling requirements for accompanying literature.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Labeling requirements for accompanying literature. 1500.125 Section 1500.125 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.125 Labeling requirements for accompanying literature. When any accompanying literature...

  11. 16 CFR 1500.125 - Labeling requirements for accompanying literature.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Labeling requirements for accompanying literature. 1500.125 Section 1500.125 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.125 Labeling requirements for accompanying literature. When any accompanying literature...

  12. Labelling of household products and prevention of unintentional poisoning.

    PubMed

    de Presgrave, Rosaura Farias; Alves, Eloisa Nunes; Camacho, Luiz Antônio Bastos; Bôas, Maria Helena Simões Villas

    2008-04-01

    Unintentional poisoning occurs mainly in childhood due to ingestion of common household products. A decisive factor is the lack of knowledge concerning the potential toxicity of these products. A random study of 158 labels of cleaning products was conducted at the National Institute of Quality Control in Health--Brazil. Health hazard warnings, first aid in case of poisoning and storage instructions were evaluated to assess the quality of information provided to the consumer regarding the risks inherent in these products. Among these labels, 75% were considered inadequate since they did not provide all cautionary information necessary to avoid the health hazards associated with these products. First aid instructions in the case of inhalation were missing on more than 50% of labels studied and 47% did not recommend taking the label to a health professional in case of accident. Furthermore, the labels did not provide other important warnings such as "read before use" and "keep in original container': The results indicate that the labelling of cleaning products does not provide all safety information recommended for consumers.

  13. 10 CFR 34.35 - Labeling, storage, and transportation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Labeling, storage, and transportation. 34.35 Section 34.35 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Equipment § 34.35 Labeling, storage, and transportation. (a...

  14. 16 CFR 1500.123 - Condensation of label information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Condensation of label information. 1500.123 Section 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides...

  15. 16 CFR 1500.123 - Condensation of label information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Condensation of label information. 1500.123 Section 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides...

  16. 16 CFR 1500.123 - Condensation of label information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Condensation of label information. 1500.123 Section 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides...

  17. 16 CFR 1500.123 - Condensation of label information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Condensation of label information. 1500.123 Section 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides...

  18. 10 CFR 34.35 - Labeling, storage, and transportation.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Labeling, storage, and transportation. 34.35 Section 34.35 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Equipment § 34.35 Labeling, storage, and transportation. (a...

  19. 10 CFR 34.35 - Labeling, storage, and transportation.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Labeling, storage, and transportation. 34.35 Section 34.35 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Equipment § 34.35 Labeling, storage, and transportation. (a...

  20. 49 CFR 583.9 - Attachment and maintenance of label.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 7 2014-10-01 2014-10-01 false Attachment and maintenance of label. 583.9 Section 583.9 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.9...

  1. 49 CFR 583.9 - Attachment and maintenance of label.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 7 2012-10-01 2012-10-01 false Attachment and maintenance of label. 583.9 Section 583.9 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.9...

  2. 49 CFR 583.9 - Attachment and maintenance of label.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 7 2013-10-01 2013-10-01 false Attachment and maintenance of label. 583.9 Section 583.9 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.9...

  3. 49 CFR 583.9 - Attachment and maintenance of label.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false Attachment and maintenance of label. 583.9 Section 583.9 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.9...

  4. 49 CFR 583.9 - Attachment and maintenance of label.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Attachment and maintenance of label. 583.9 Section 583.9 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.9...

  5. Safety and Tolerability of Methylphenidate in Preschool Children with ADHD

    ERIC Educational Resources Information Center

    Wigal, Tim; Greenhill, Laurence; Chuang, Shirley; McGough, James; Vitiello, Benedetto; Skrobala, Anne; Swanson, James; Wigal, Sharon; Abikoff, Howard; Kollins, Scott; McCracken, James; Riddle, Mark; Posner, Kelly; Ghuman, Jaswinder; Davies, Mark; Thorp, Ben; Stehli, Annamarie

    2006-01-01

    Objective: To report on the safety and tolerability of methylphenidate (MPH) 3- to 5-year-old children with attention-deficit/hyperactivity disorder (ADHD) during 1 year of treatment. Method: Exactly 183 children (3-5 years old) entered a treatment study of MPH, consisting of a 1-week open-label lead-in (n = 183); a 5-week placebo-controlled,…

  6. Safety and Tolerability of Atomoxetine over 3 to 4 Years in Children with ADHD

    ERIC Educational Resources Information Center

    Donnelly, Craig; Bangs, Mark; Trzepacz, Paula; Jin, Ling; Zhang, Shuyu; Witte, Michael M.; Ball, Susan G.; Spencer, Thomas J.

    2009-01-01

    Data from 13 double-blind, placebo-controlled trials and three open-label extension studies were pooled to examine the safety of atomoxetine for treating attention deficit hyperactivity disorder in children and adolescents for less than or equal to three or four years. Results show that atomoxetine is safe and well tolerated in the subjects.

  7. An open-label study to evaluate the long-term safety and efficacy of lanadelumab for prevention of attacks in hereditary angioedema: design of the HELP study extension.

    PubMed

    Riedl, Marc A; Bernstein, Jonathan A; Craig, Timothy; Banerji, Aleena; Magerl, Markus; Cicardi, Marco; Longhurst, Hilary J; Shennak, Mustafa M; Yang, William H; Schranz, Jennifer; Baptista, Jovanna; Busse, Paula J

    2017-01-01

    Hereditary angioedema (HAE) is characterized by recurrent attacks of subcutaneous or submucosal edema. Attacks are unpredictable, debilitating, and have a significant impact on quality of life. Patients may be prescribed prophylactic therapy to prevent angioedema attacks. Current prophylactic treatments may be difficult to administer (i.e., intravenously), require frequent administrations or are not well tolerated, and breakthrough attacks may still occur frequently. Lanadelumab is a subcutaneously-administered monoclonal antibody inhibitor of plasma kallikrein in clinical development for prophylaxis of hereditary angioedema attacks. A Phase 1b study supported its efficacy in preventing attacks. A Phase 3, randomized, double-blind, placebo-controlled, parallel-arm study has been completed and an open-label extension is currently ongoing. The primary objective of the open-label extension is to evaluate the long-term safety of repeated subcutaneous administrations of lanadelumab in patients with type I/II HAE. Secondary objectives include evaluation of efficacy and time to first angioedema attack to determine outer bounds of the dosing interval. The study will also evaluate immunogenicity, pharmacokinetics/pharmacodynamics, quality of life, characteristics of breakthrough attacks, ease of self-administration, and safety/efficacy in patients who switch to lanadelumab from another prophylactic therapy. The open-label extension will enroll patients who completed the double-blind study ("rollover patients") and those who did not participate in the double-blind study ("non-rollover patients"), which includes patients who may or may not be currently using another prophylactic therapy. Rollover patients will receive a single 300 mg dose of lanadelumab on Day 0 and the second dose after the patient's first confirmed angioedema attack. Thereafter, lanadelumab will be administered every 2 weeks. Non-rollover patients will receive 300 mg lanadelumab every 2 weeks regardless of the first attack. All patients will receive their last dose on Day 350 (maximum of 26 doses), and will then undergo a 4-week follow-up. Prevention of attacks can reduce the burden of illness associated with HAE. Prophylactic therapy requires extended, repeated dosing and the results of this study will provide important data on the long-term safety and efficacy of lanadelumab, a monoclonal antibody inhibitor of plasma kallikrein for subcutaneous administration for the treatment of HAE. Trial registration NCT02741596.

  8. A 12-Month Open-Label Extension Study of the Safety and Tolerability of Lisdexamfetamine Dimesylate for Major Depressive Disorder in Adults.

    PubMed

    Richards, Cynthia; Iosifescu, Dan V; Mago, Rajnish; Sarkis, Elias; Geibel, Brooke; Dauphin, Matthew; McIntyre, Roger S; Weisler, Richard; Brawman-Mintzer, Olga; Gu, Joan; Madhoo, Manisha

    2018-06-16

    Psychostimulant augmentation is considered a potential treatment strategy for individuals with major depressive disorder who do not adequately respond to antidepressant monotherapy. The primary objective of this 12-month open-label extension study was to evaluate the safety and tolerability of lisdexamfetamine dimesylate (LDX) as augmentation therapy to an antidepressant in adults with major depressive disorder. Eligible adults who completed 1 of 3 short-term antecedent LDX augmentation of antidepressant monotherapy studies were treated with dose-optimized LDX (20-70 mg) for up to 52 weeks while continuing on the index antidepressant (escitalopram, sertraline, venlafaxine extended-release, or duloxetine) assigned during the antecedent short-term studies. Safety and tolerability assessments included the occurrence of treatment-emergent adverse events and vital sign changes. All 3 antecedent studies failed to meet the prespecified primary efficacy endpoint, so this open-label study was terminated early. Headache (15.5% [241/1559]), dry mouth (13.6% [212/1559]), insomnia (13.1% [204/1559]), and decreased appetite (12.1% [189/1559]) were the most frequently reported treatment-emergent adverse events. The greatest mean ± SD increases observed for systolic and diastolic blood pressure and for pulse were 2.6 ± 10.85 and 1.7 ± 7.94 mm Hg and 6.9 ± 10.27 bpm, respectively. Monitoring determined that less than 1% of participants experienced potentially clinically important changes in systolic blood pressure (10 [0.6%]), diastolic blood pressure (8 [0.5%]), or pulse (6 [0.4%]). The overall safety and tolerability of long-term LDX augmentation of antidepressant monotherapy was consistent with the profiles of the short-term antecedent studies, with no evidence of new safety signals.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

  9. 30 CFR 56.4402 - Safety can use.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Safety can use. 56.4402 Section 56.4402 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND... drawn from storage shall be kept in safety cans labeled to indicate the contents. ...

  10. 30 CFR 57.4402 - Safety can use.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Safety can use. 57.4402 Section 57.4402 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND... drawn from storage shall be kept in safety cans labeled to indicate the contents. ...

  11. PRIORITIZING FUTURE RESEACH ON OFF-LABEL PRESCRIBING: RESULTS OF A QUANTITATIVE EVALUATION

    PubMed Central

    Walton, Surrey M.; Schumock, Glen T.; Lee, Ky-Van; Alexander, G. Caleb; Meltzer, David; Stafford, Randall S.

    2015-01-01

    Background Drug use for indications not approved by the Food and Drug Administration exceeds 20% of prescribing. Available compendia indicate that a minority of off-label uses are well supported by evidence. Policy makers, however, lack information to identify where systematic reviews of the evidence or other research would be most valuable. Methods We developed a quantitative model for prioritizing individual drugs for future research on off-label uses. The base model incorporated three key factors, 1) the volume of off-label use with inadequate evidence, 2) safety, and 3) cost and market considerations. Nationally representative prescribing data were used to estimate the number of off-label drug uses by indication from 1/2005 through 6/2007 in the United States, and these indications were then categorized according to the adequacy of scientific support. Black box warnings and safety alerts were used to quantify drug safety. Drug cost, date of market entry, and marketing expenditures were used to quantify cost and market considerations. Each drug was assigned a relative value for each factor, and the factors were then weighted in the final model to produce a priority score. Sensitivity analyses were conducted by varying the weightings and model parameters. Results Drugs that were consistently ranked highly in both our base model and sensitivity analyses included quetiapine, warfarin, escitalopram, risperidone, montelukast, bupropion, sertraline, venlafaxine, celecoxib, lisinopril, duloxetine, trazodone, olanzapine, and epoetin alfa. Conclusion Future research into off-label drug use should focus on drugs used frequently with inadequate supporting evidence, particularly if further concerns are raised by known safety issues, high drug cost, recent market entry, and extensive marketing. Based on quantitative measures of these factors, we have prioritized drugs where targeted research and policy activities have high potential value. PMID:19025425

  12. Food and nutrition labelling in Thailand: a long march from subsistence producers to international traders

    PubMed Central

    Rimpeekool, Wimalin; Seubsman, Sam-ang; Banwell, Cathy; Kirk, Martyn; Yiengprugsawan, Vasoontara; Sleigh, Adrian

    2015-01-01

    This paper reviews the evolution of Thai food and nutrition label policies and Thailand’s international role relating to food product safety and standards. The historical record has been interpreted to identify future trends and challenges related to food labelling. These challenges are arising in Thailand and many similar emerging economies. Thailand has a good reputation in world food markets and is now becoming a global leader in food production and export. It has become deeply involved with regulations and standards applied by World Trade Organization and Codex Alimentarius while serving its own population with a safe and secure food supply. For consumers considering Thai food products, food labels can provide useful nutrition information and help build trust. Thais began a century ago with policies and laws to enhance food safety and to protect Thai consumers. During the lengthy journey from national to global standards Thai food labels have evolved and now contribute to international food labelling policies. This contribution comes from the perspective of a leading middle income south-east Asian food producer now trading with high income countries around the world. The story of that journey – a case study for many other countries in a similar situation – has not previously been told. This article provides information for policy makers dealing with food labelling, embedding trends and tensions for one middle income food exporter in a long history. Information captured here should be helpful for other middle income countries, especially those with limited records. This strategic knowledge will enable better decisions for future policies. PMID:26538793

  13. Efficacy and safety of darunavir (Prezista®) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study

    PubMed Central

    Benea, Otilia Elisabeta; Streinu-Cercel, Adrian; Dorobăţ, Carmen; Rugină, Sorin; Negruţiu, Lucian; Cupşa, Augustin; Duiculescu, Dan; Chiriac, Carmen; Itu, Corina; Prisăcariu, Liviu Jany; Iosif, Ionel

    2014-01-01

    Introduction The aim of the study was to assess the safety and efficacy of darunavir (Prezista®) used in subtype F human immunodeficiency virus – type 1 (HIV-1) infected, antiretroviral therapy (ART)-experienced patients in Romania in routine clinical practice. Methods This was a post-authorization, open-label, one-cohort, non-interventional, prospective study conducted at multiple sites in Romania to assess efficacy (CD4 cell count, viral load, and treatment compliance) and safety ([serious] adverse events, clinical laboratory evaluation, and vital signs) of darunavir in combination with low-dose ritonavir (DRV/r) and other antiretroviral (ARV) medications in subtype F HIV-1 infected subjects in naturalistic settings. Seventy-eight subjects were recruited by 9 investigational sites and received 600/100 mg DRV/r twice daily. Results Treatment with DRV/r administered with other ARV medications resulted in the expected, statistically relevant improvement of CD4 cell count and viral load in subjects eligible for such treatment. In addition, adherence to treatment was high and the treatment-emergent safety profile observed during this study was consistent with the established safety profile of darunavir. Conclusion DRV/r administered in combination with other ARV medications in subtype F HIV-1 infected subjects in naturalistic settings proved to be an effective and safe treatment in Romania. Trial registration NCT01253967 PMID:25276665

  14. Chemical safety practice amongst the health workers of Fiji.

    PubMed

    Naduva, Adriu

    2006-09-01

    The National Health Service of Fiji includes private and public institutions that use a variety of chemicals of varying hazardousness. A survey was carried out to describe chemical safety issues amongst health workers in Fiji. Questionnaires were given to 133 private and Government health institutions. Most health facilities lack awareness on safe chemical waste management and do not have technical training on chemical safety. Most institutions do not have chemical handling, packaging and labelling procedure and equipment with a marked deficiency in the vector sector. Most facilities state that they have adequate chemical safety information from the suppliers, while a few alarmingly still resort to container labels and information from colleagues.

  15. Utility and importance of animal data in drug product labels.

    PubMed

    Baldrick, Paul

    2014-08-01

    Information on the use and safety of medicines to assist prescription by healthcare professionals occurs in drug labels (Summary of Product Characteristics in Europe and Package Insert in the USA). Animal data (notably genotoxicity, reproduction toxicity and carcinogenicity and/or repeat dose toxicity testing) comprise an important component of the information (having a vital role in giving assurance that an extensive safety assessment for the medicinal product has occurred) and regulatory guidance is available to help inform on its input into drug labels. However, an evaluation of animal data for the 27 new drugs approved in the USA in 2013 (and the same drugs if available in Europe) shows great variability in detail and level of information presented within and across regions and/or the possibility of confusion on interpretation of some of the presented animal study findings. It is concluded that it may be time to revisit what animal data are presented in drug product labels (although bearing in mind current regional regulatory guidance requirements), not only to allow within and across region consistency on information given but to present it in a way that fully assists healthcare professions when prescribing a medicine. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. 16 CFR § 1500.123 - Condensation of label information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Condensation of label information. § 1500.123 Section § 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS... § 1500.123 Condensation of label information. Whenever the statement of the principal hazard or hazards...

  17. 16 CFR § 1500.125 - Labeling requirements for accompanying literature.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Labeling requirements for accompanying literature. § 1500.125 Section § 1500.125 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.125 Labeling requirements for accompanying literature. When any accompanying literature...

  18. 16 CFR 1211.25 - Product certification and labeling by importers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by importers. 1211.25 Section 1211.25 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT... § 1211.25 Product certification and labeling by importers. (a) General. The importer of any automatic...

  19. FDA drug labeling: rich resources to facilitate precision medicine, drug safety, and regulatory science.

    PubMed

    Fang, Hong; Harris, Stephen C; Liu, Zhichao; Zhou, Guangxu; Zhang, Guoping; Xu, Joshua; Rosario, Lilliam; Howard, Paul C; Tong, Weida

    2016-10-01

    Here, we provide a concise overview of US Food and Drug Administration (FDA) drug labeling, which details drug products, drug-drug interactions, adverse drug reactions (ADRs), and more. Labeling data have been collected over several decades by the FDA and are an important resource for regulatory research and decision making. However, navigating through this data is challenging. To aid such navigation, the FDALabel database was developed, which contains a set of approximately 80000 labeling data. The full-text searching capability of FDALabel and querying based on any combination of specific sections, document types, market categories, market date, and other labeling information makes it a powerful and attractive tool for a variety of applications. Here, we illustrate the utility of FDALabel using case scenarios in pharmacogenomics biomarkers and ADR studies. Published by Elsevier Ltd.

  20. Demographic determinants of chemical safety information recall in workers and consumers in South Africa: A cross sectional study.

    PubMed

    Sathar, Farzana; Dalvie, Mohamed Aqiel; Rother, Hanna-Andrea; London, Leslie

    2017-12-01

    Chemical hazard communication is intended to alert users of the potential hazards of chemicals. Hazard information needs to be understood and recalled. Recall of hazard communication is critical when the written form of the information is not available at the time it is required. A cross-sectional study investigating associations between recall of chemical safety information on labels amongst 402 participants including 315 workers and 87 consumers in two provinces of South Africa. Respondents were predominantly male (67.7%), the median age was 37 years (IQR: 30-46years) and less than half of the participants completed high school (47.5%). Multivariate analysis identified the following positive associations with the recall of all the label elements listing the strongest association: call appropriate services and industrial vs consumer sector (OR=2.4; 95% CI: 1.2; 4.6 ); call appropriate services and transport vs consumer sector (OR=4.4; 95% CI: 1.2; 16.0); flammable symbol and male vs female gender (OR=2.3; 95% CI: 1.0; 5.3); flammable symbol and home language English vs African languages (OR=6.6; 95% CI: 2.1; 21.2); any hazard statement and home language Afrikaans vs African languages (OR=14.0; 95% CI: 3.6; 54.2), any first aid statement and further education vs none (OR=3.3; 95% CI: 1.3; 8.0), correct chemical name and industry blue collar workers vs non-industry blue collar workers (OR=2.6; 95% CI: 1.1; 6.1), correct chemical name and non-industry white collar occupations vs non-industry blue collar workers (OR=2.7; 95% CI: 1.0; 7.1). The study found a number of potential positive associations which influence recall of label elements of which some (e.g., sector, gender, occupation) suggest further research. Relevant policies in South Africa should ensure that the safety information on chemical labels is clearly visible to read and understandable which aids recall and the reduction in harmful chemical exposures. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

  1. Shelf Life of Food Products: From Open Labeling to Real-Time Measurements.

    PubMed

    Corradini, Maria G

    2018-03-25

    The labels currently used on food and beverage products only provide consumers with a rough guide to their expected shelf lives because they assume that a product only experiences a limited range of predefined handling and storage conditions. These static labels do not take into consideration conditions that might shorten a product's shelf life (such as temperature abuse), which can lead to problems associated with food safety and waste. Advances in shelf-life estimation have the potential to improve the safety, reliability, and sustainability of the food supply. Selection of appropriate kinetic models and data-analysis techniques is essential to predict shelf life, to account for variability in environmental conditions, and to allow real-time monitoring. Novel analytical tools to determine safety and quality attributes in situ coupled with modern tracking technologies and appropriate predictive tools have the potential to provide accurate estimations of the remaining shelf life of a food product in real time. This review summarizes the necessary steps to attain a transition from open labeling to real-time shelf-life measurements.

  2. Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union - Croatian experiences.

    PubMed

    Vujić, Mario; Pollak, Lea

    2015-12-01

    The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

  3. 49 CFR 575.302 - Vehicle labeling of safety rating information (compliance required for model year 2012 and later...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... label specified in paragraph (f) of this section. (2) The label must depict the star ratings for that...,” “Rear Seat” and where applicable, “Not Rated” or “To Be Rated,” the star graphic indicating each rating... point. All remaining text and symbols on the label (including the star graphic specified in paragraph (e...

  4. 49 CFR 575.302 - Vehicle labeling of safety rating information (compliance required for model year 2012 and later...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... label specified in paragraph (f) of this section. (2) The label must depict the star ratings for that...,” “Rear Seat” and where applicable, “Not Rated” or “To Be Rated,” the star graphic indicating each rating... point. All remaining text and symbols on the label (including the star graphic specified in paragraph (e...

  5. 49 CFR 575.302 - Vehicle labeling of safety rating information (compliance required for model year 2012 and later...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... label specified in paragraph (f) of this section. (2) The label must depict the star ratings for that...,” “Rear Seat” and where applicable, “Not Rated” or “To Be Rated,” the star graphic indicating each rating... point. All remaining text and symbols on the label (including the star graphic specified in paragraph (e...

  6. The Influence of Sugar-Sweetened Beverage Health Warning Labels on Parents' Choices.

    PubMed

    Roberto, Christina A; Wong, Diandra; Musicus, Aviva; Hammond, David

    2016-02-01

    US states have introduced bills requiring sugar-sweetened beverages (SSBs) to display health warning labels. This study examined how such labels may influence parents and which labels are most impactful. In this study, 2381 demographically and educationally diverse parents participated in an online survey. Parents were randomly assigned to 1 of 6 conditions: (1) no warning label (control); (2) calorie label; or (3-6) 1 of 4 text versions of a warning label (eg, Safety Warning: Drinking beverages with added sugar[s] contributes to obesity, diabetes, and tooth decay). Parents chose a beverage for their child in a vending machine choice task, rated perceptions of different beverages, and indicated interest in receiving beverage coupons. Regression analyses controlling for frequency of beverage purchases were used to compare the no warning label group, calorie label group, and all warning label groups combined. Significantly fewer parents chose an SSB for their child in the warning label condition (40%) versus the no label (60%) and calorie label conditions (53%). Parents in the warning label condition also chose significantly fewer SSB coupons, believed that SSBs were less healthy for their child, and were less likely to intend to purchase SSBs. All P values <.05 after correcting for multiple comparisons. There were no consistent differences among different versions of the warning labels. Health warning labels on SSBs improved parents' understanding of health harms associated with overconsumption of such beverages and may reduce parents' purchase of SSBs for their children. Copyright © 2016 by the American Academy of Pediatrics.

  7. Off-label and unlicensed drug use in hospitalized newborns in a Saudi tertiary care hospital: a cohort study.

    PubMed

    Mazhar, Faizan; Akram, Shahzad; Haider, Nafis; Hadi, Muhammad Abdul; Sultana, Jabeen

    2018-06-01

    Objective To determine the extent of off-label and unlicensed prescribing in hospitalized newborns and to identify patient-related risk factors associated with off-label prescribing. Methods A prospective cohort study was conducted between January and March 2016 at a neonatology department of a tertiary-care hospital in the Eastern province. All consecutive admissions to all neonatal care levels meeting the inclusion and exclusion criteria were eligible for enrollment. All prescriptions were classified as off-label or unlicensed according to drug product monograph. Clinical and prescription data were extracted using a pilot-tested structured data collection sheet. Results During the study period 583 prescriptions were made for 138 newborns, of which 29.7% (173/583) and 12.9% (75/583) were classified as off-label and unlicensed drugs respectively for use in neonates. Thirty-four percent (47/138) of patients received at least one off-label/unlicensed medicine. Mechanical ventilation, admission to the neonatal intensive care unit and length of hospital stay were identified as independent risk factors associated with prescribing of at least one off-label medication. Conclusion Use of off-label and unlicensed drugs in hospitalized newborns seems to be a common practice in this Saudi hospital. Future research should evaluate safety and efficacy of off-label and/or unlicensed use of drugs in neonates.

  8. Precautionary labelling of foods for allergen content: are we ready for a global framework?

    PubMed

    Allen, Katrina J; Turner, Paul J; Pawankar, Ruby; Taylor, Stephen; Sicherer, Scott; Lack, Gideon; Rosario, Nelson; Ebisawa, Motohiro; Wong, Gary; Mills, E N Clare; Beyer, Kirsten; Fiocchi, Alessandro; Sampson, Hugh A

    2014-01-01

    Food allergy appears to be on the rise with the current mainstay of treatment centred on allergen avoidance. Mandatory allergen labelling has improved the safety of food for allergic consumers. However an additional form of voluntary labelling (termed precautionary allergen labelling) has evolved on a wide range of packaged goods, in a bid by manufacturers to minimise risk to customers, and the negative impact on business that might result from exposure to trace amounts of food allergen present during cross-contamination during production. This has resulted in near ubiquitous utilisation of a multitude of different precautionary allergen labels with subsequent confusion amongst many consumers as to their significance. The global nature of food production and manufacturing makes harmonisation of allergen labelling regulations across the world a matter of increasing importance. Addressing inconsistencies across countries with regards to labelling legislation, as well as improvement or even banning of precautionary allergy labelling are both likely to be significant steps forward in improved food safety for allergic families. This article outlines the current status of allergen labelling legislation around the world and reviews the value of current existing precautionary allergen labelling for the allergic consumer. We strongly urge for an international framework to be considered to help roadmap a solution to the weaknesses of the current systems, and discuss the role of legislation in facilitating this.

  9. Precautionary labelling of foods for allergen content: are we ready for a global framework?

    PubMed Central

    2014-01-01

    Food allergy appears to be on the rise with the current mainstay of treatment centred on allergen avoidance. Mandatory allergen labelling has improved the safety of food for allergic consumers. However an additional form of voluntary labelling (termed precautionary allergen labelling) has evolved on a wide range of packaged goods, in a bid by manufacturers to minimise risk to customers, and the negative impact on business that might result from exposure to trace amounts of food allergen present during cross-contamination during production. This has resulted in near ubiquitous utilisation of a multitude of different precautionary allergen labels with subsequent confusion amongst many consumers as to their significance. The global nature of food production and manufacturing makes harmonisation of allergen labelling regulations across the world a matter of increasing importance. Addressing inconsistencies across countries with regards to labelling legislation, as well as improvement or even banning of precautionary allergy labelling are both likely to be significant steps forward in improved food safety for allergic families. This article outlines the current status of allergen labelling legislation around the world and reviews the value of current existing precautionary allergen labelling for the allergic consumer. We strongly urge for an international framework to be considered to help roadmap a solution to the weaknesses of the current systems, and discuss the role of legislation in facilitating this. PMID:24791183

  10. 46 CFR 98.25-15 - Markings.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... safety relief valves, liquid level gaging devices and pressure gages shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of noncorrosive material may be attached to...

  11. 46 CFR 98.25-15 - Markings.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... safety relief valves, liquid level gaging devices and pressure gages shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of noncorrosive material may be attached to...

  12. 46 CFR 98.25-15 - Markings.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... safety relief valves, liquid level gaging devices and pressure gages shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of noncorrosive material may be attached to...

  13. 46 CFR 98.25-15 - Markings.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... safety relief valves, liquid level gaging devices and pressure gages shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of noncorrosive material may be attached to...

  14. 46 CFR 98.25-15 - Markings.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... safety relief valves, liquid level gaging devices and pressure gages shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of noncorrosive material may be attached to...

  15. Erenumab (AMG 334) in episodic migraine: Interim analysis of an ongoing open-label study.

    PubMed

    Ashina, Messoud; Dodick, David; Goadsby, Peter J; Reuter, Uwe; Silberstein, Stephen; Zhang, Feng; Gage, Julia R; Cheng, Sunfa; Mikol, Daniel D; Lenz, Robert A

    2017-09-19

    To assess long-term safety and efficacy of anti-calcitonin gene-related peptide receptor erenumab in patients with episodic migraine (EM). Patients enrolled in a 12-week, double-blind, placebo-controlled clinical trial (NCT01952574) who continued in an open-label extension (OLE) study will receive erenumab 70 mg every 4 weeks for up to 5 years. This preplanned interim analysis, conducted after all participants had completed the 1-year open-label follow-up, evaluated changes in monthly migraine days (MMD), achievement of ≥50%, ≥75%, and 100% reductions, Headache Impact Test (HIT-6) score, Migraine-Specific Quality of Life (MSQ), Migraine Disability Assessment (MIDAS), and safety. Data reported as observed without imputation for missing data. Of 472 patients enrolled in the parent study, 383 continued in the OLE with a median exposure to erenumab of 575 days (range 28-822 days). Mean (SD) MMD were 8.8 (2.6) at parent study baseline, 6.3 (4.2) at week 12 (beginning of OLE), and 3.7 (4.0) at week 64 (mean change from baseline [reduction] of 5.0 days). At week 64, 65%, 42%, and 26% achieved ≥50%, ≥75%, and 100% reduction in MMD, respectively. Mean HIT-6 scores were 60.2 (6.3) at baseline and 51.7 (9.2) at week 64. MSQ and MIDAS improvements from baseline were maintained through week 64. Safety profiles during the OLE were similar to those in the double-blind phase, which overall were similar to placebo. One-year efficacy, supported by functional improvements and favorable safety and tolerability profiles, supports further investigation of erenumab as a preventive treatment in patients with EM. NCT01952574. This study provides Class IV evidence that for patients with episodic migraine, erenumab reduces long-term MMD and improves headache-related disability and migraine-specific quality of life. © 2017 American Academy of Neurology.

  16. 77 FR 46677 - Vehicle Certification; Contents of Certification Labels

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-06

    ...This document proposes to clarify the National Highway Traffic Safety Administration (NHTSA) regulations that prescribe the format and contents of certification labels that manufacturers are statutorily required to affix to motor vehicles manufactured for sale in the United States. The proposal would require specified language on the certification labels for certain types of vehicles.

  17. 9 CFR 381.115 - Containers of inspected and passed poultry products required to be labeled.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... poultry products required to be labeled. 381.115 Section 381.115 Animals and Animal Products FOOD SAFETY... AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Labeling and Containers § 381.115 Containers of inspected and passed poultry products required to...

  18. 9 CFR 317.13 - Storage and distribution of labels and containers bearing official marks.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... containers bearing official marks. 317.13 Section 317.13 Animals and Animal Products FOOD SAFETY AND... General § 317.13 Storage and distribution of labels and containers bearing official marks. Labels, wrappers, and containers bearing any official marks, with or without the establishment number, may be...

  19. The Role of Labeling in Chemical Health and Safety: Recent Developments.

    ERIC Educational Resources Information Center

    Young, Jay A.

    1983-01-01

    The purpose of constructing labels is to communicate those scientific facts related to hazards and to select and describe the reasonable precautions that should be taken to prevent otherwise unforseeable harm. Recent developments in the use of combined numeric and pictorial symbols in chemical label construction are described. (JN)

  20. A multicentre, open-label, follow-on study to assess the long-term maintenance of effect, tolerance and safety of THC/CBD oromucosal spray in the management of neuropathic pain.

    PubMed

    Hoggart, B; Ratcliffe, S; Ehler, E; Simpson, K H; Hovorka, J; Lejčko, J; Taylor, L; Lauder, H; Serpell, M

    2015-01-01

    Peripheral neuropathic pain (PNP) poses a significant clinical challenge. The long-term efficacy of delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray was investigated in this 38-week open-label extension study. In total, 380 patients with PNP associated with diabetes or allodynia entered this study from two parent randomised, controlled trials. Patients received THC/CBD spray for a further 38 weeks in addition to their current analgesic therapy. Neuropathic pain severity was the primary efficacy measure using a pain 0-10 numerical rating scale (NRS). Additional efficacy, safety and tolerability outcomes were also investigated. In total, 234 patients completed the study (62 %). The pain NRS showed a decrease in score over time in patients from a mean of 6.9 points (baseline in the parent studies) to a mean of 4.2 points (end of open-label follow-up). The proportion of patients who reported at least a clinically relevant 30 % improvement in pain continued to increase with time (up to 9 months); at least half of all patients reported a 30 % improvement at all time points. Improvements were observed for all secondary efficacy outcomes, including sleep quality 0-10 NRS scores, neuropathic pain scale scores, subject global impression of change and EQ-5D questionnaire scores. THC/CBD spray was well tolerated for the study duration and patients did not seek to increase their dose with time, with no new safety concerns arising from long-term use. In this previously difficult to manage patient population, THC/CBD spray was beneficial for the majority of patients with PNP associated with diabetes or allodynia.

  1. 46 CFR 38.05-5 - Markings-TB/ALL.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., except safety relief valves, liquid level gaging devices, and pressure gages, shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of corrosion-resistant material may be...

  2. 46 CFR 38.05-5 - Markings-TB/ALL.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., except safety relief valves, liquid level gaging devices, and pressure gages, shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of corrosion-resistant material may be...

  3. 46 CFR 38.05-5 - Markings-TB/ALL.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., except safety relief valves, liquid level gaging devices, and pressure gages, shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of corrosion-resistant material may be...

  4. 46 CFR 38.05-5 - Markings-TB/ALL.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ..., except safety relief valves, liquid level gaging devices, and pressure gages, shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of corrosion-resistant material may be...

  5. 46 CFR 38.05-5 - Markings-TB/ALL.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., except safety relief valves, liquid level gaging devices, and pressure gages, shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of corrosion-resistant material may be...

  6. Safety Issues in Controlling Bed Bugs

    EPA Pesticide Factsheets

    Prevent pesticide misuse by always following label directions carefully. For example don't use a pesticide indoors that is labeled for outdoor use, prepare treatment area as instructed, and look for an EPA registration number.

  7. Obesity and Pediatric Drug Development.

    PubMed

    Vaughns, Janelle D; Conklin, Laurie S; Long, Ying; Zheng, Panli; Faruque, Fahim; Green, Dionna J; van den Anker, John N; Burckart, Gilbert J

    2018-05-01

    There is a lack of dosing guidelines for use in obese children. Moreover, the impact of obesity on drug safety and clinical outcomes is poorly defined. The paucity of information needed for the safe and effective use of drugs in obese patients remains a problem, even after drug approval. To assess the current incorporation of obesity as a covariate in pediatric drug development, the pediatric medical and clinical pharmacology reviews under the Food and Drug Administration (FDA) Amendments Act of 2007 and the FDA Safety and Innovation Act (FDASIA) of 2012 were reviewed for obesity studies. FDA labels were also reviewed for statements addressing obesity in pediatric patients. Forty-five drugs studied in pediatric patients under the FDA Amendments Act were found to have statements and key words in the medical and clinical pharmacology reviews and labels related to obesity. Forty-four products were identified similarly with pediatric studies under FDASIA. Of the 89 product labels identified, none provided dosing information related to obesity. The effect of body mass index on drug pharmacokinetics was mentioned in only 4 labels. We conclude that there is little information presently available to provide guidance related to dosing in obese pediatric patients. Moving forward, regulators, clinicians, and the pharmaceutical industry should consider situations in drug development in which the inclusion of obese patients in pediatric trials is necessary to facilitate the safe and effective use of new drug products in the obese pediatric population. © 2018, The American College of Clinical Pharmacology.

  8. Car radiator burns: a prevention issue.

    PubMed

    Rabbitts, Angela; Alden, Nicole E; Conlin, Tara; Yurt, Roger W

    2004-01-01

    Scald burns continue to be the major cause of injury to patients admitted to the burn center. Scald burns occurring from car radiator fluid comprise a significant subgroup. Although manufacturer warning labels have been placed on car radiators, these burns continue to occur. This retrospective review looks at all patients admitted to our burn center who suffered scald burns from car radiator fluid to assess the extent of this problem. During the study period, 86 patients were identified as having suffered scald burns as a result of contact with car radiator fluid. Seventy-one percent of the burn injuries occurred in the summer months. The areas most commonly burned were the head and upper extremities. Burn prevention efforts have improved greatly over the years; however, this study demonstrates that scald burns from car radiator fluid continue to cause physical, emotional, and financial devastation. The current radiator warning labels alone are not effective. The National Highway Traffic Safety Administration has proposed a new federal motor vehicle safety standard to aid in decreasing the number of scald burns from car radiators. The results of this study were submitted to the United States Department of Transportation for inclusion in a docket for federal legislation supporting these safety measures.

  9. Off-label prescribing during pregnancy in the UK: an analysis of 18,000 prescriptions in Liverpool Women's Hospital.

    PubMed

    Herring, Christopher; McManus, Aine; Weeks, Andrew

    2010-08-01

    Large numbers of drugs are prescribed antenatally, many of which are off-label or unlicensed. An off-label medication is one which does have a market authorization, but for a different indication, dose, route or patient group than that for which it is prescribed. The purpose of this study was to determine how commonly these prescriptions are written at Liverpool Women's Hospital (LWH), a unit with 8000 deliveries per annum. All inpatient prescriptions received from antenatal areas at LWH during a 3-month period were analysed. The drugs were divided into categories according to their licence, FDA class and degree of clinical risk. Some 17 694 prescriptions of 235 different drugs were prescribed during this period. Thirty-seven (16%) drugs and 4445 (25%) medications prescribed were licensed for use in pregnancy; 57 (24%) drugs and 3363 (19%) of the total prescriptions were off-label but considered safe by the manufacturers (e.g. erythromycin, prochlorperazine and clotrimazole); 138 (58%) drugs and 9722 (55%) prescriptions were cautioned or contraindicated by the manufacturer in pregnancy (e.g. cefalexin, magnesium sulphate and nifedipine). After further investigation into the safety of the off-label medications from the FDA safety profile and with the opinion of a multidisciplinary team, we were able to draw up a list of high-risk off-label medicines. This consisted of 38 drugs (16% of total) and 1735 (10%) of the total prescriptions (e.g. lisinopril, diazepam and morphine). A significant number of prescriptions being used in an off-label manner at LWH are high risk. Prescribers need to be aware of the risks associated with these drugs and the possible legal consequences of prescribing and administering them.

  10. An open-label, single arm, phase III clinical study to evaluate the efficacy and safety of CJ smallpox vaccine in previously vaccinated healthy adults.

    PubMed

    Kim, Nak-Hyun; Kang, Yu Min; Kim, Gayeon; Choe, Pyoeng Gyun; Song, Jin Su; Lee, Kwang-Hee; Seong, Baik-Lin; Park, Wan Beom; Kim, Nam Joong; Oh, Myoung-don

    2013-10-25

    The increased possibility of bioterrorism has led to reinitiation of smallpox vaccination. In Korea, more than 30 years have passed since the last smallpox vaccinations, and even people who were previously vaccinated are not regarded as adequately protected against smallpox. We evaluated the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy adults previously vaccinated against smallpox. We conducted an open label, single arm, phase III clinical trial to evaluate the efficacy and safety of CJ-50300. Healthy volunteers, previously vaccinated against smallpox, born between 1950 and 1978 were enrolled. CJ-50300 was administered with a bifurcated needle over the deltoid muscle according to the recommended method. The rate of the cutaneous take reaction, humoral immunogenicity, and safety of the vaccine was assessed. Of 145 individuals enrolled for vaccination, 139 completed the study. The overall rates of cutaneous take reactions and humoral immunogenicity were 95.0% (132/139) and 88.5% (123/139), respectively. Although 95.9% (139/145) reported adverse events related to vaccination, no serious adverse reactions were observed. CJ-50300 can be used safely and effectively in healthy adults previously vaccinated against smallpox. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. 16 CFR 1102.6 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Background and Definitions § 1102.6 Definitions. (a... Database. (2) Commission or CPSC means the Consumer Product Safety Commission. (3) Consumer product means a... private labeler. (7) Publicly Available Consumer Product Safety Information Database, also referred to as...

  12. 16 CFR 1102.6 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Background and Definitions § 1102.6 Definitions. (a... Database. (2) Commission or CPSC means the Consumer Product Safety Commission. (3) Consumer product means a... private labeler. (7) Publicly Available Consumer Product Safety Information Database, also referred to as...

  13. 16 CFR 1209.34 - Qualification testing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ....34 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION Certification § 1209.34 Qualification testing. (a... labelers, or importers may select samples for qualification testing of a product in any manner they desire. ...

  14. Clinical Efficacy and Safety of Ranibizumab Versus Dexamethasone for Central Retinal Vein Occlusion (COMRADE C): A European Label Study.

    PubMed

    Hoerauf, Hans; Feltgen, Nicolas; Weiss, Claudia; Paulus, Eva-Maria; Schmitz-Valckenberg, Steffen; Pielen, Amelie; Puri, Pankaj; Berk, Hüsnü; Eter, Nicole; Wiedemann, Peter; Lang, Gabriele E; Rehak, Matus; Wolf, Armin; Bertelmann, Thomas; Hattenbach, Lars-Olof

    2016-09-01

    To compare the efficacy and safety of the European labels of ranibizumab 0.5 mg vs dexamethasone 0.7 mg in patients with macular edema secondary to central retinal vein occlusion (CRVO). Phase IIIb, multicenter, double-masked, randomized clinical trial. Patients were randomized (1:1) to receive either monthly ranibizumab followed by pro re nata (PRN) treatment (n = 124) or 1 sustained-release dexamethasone implant followed by PRN sham injections (n = 119). Main outcomes were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean change in BCVA, and adverse events (AEs). Of 243 patients, 185 (76.1%) completed the study. No difference was observed in BCVA between ranibizumab and dexamethasone at months 1 and 2. From month 3 to month 6, there was significant difference in BCVA gains in favor of ranibizumab. At month 6, mean average BCVA gain was significantly higher with ranibizumab than with dexamethasone (12.86 vs 2.96 letters; difference 9.91 letters, 95% confidence interval [6.51-13.30]; P < .0001). Mean injection number of ranibizumab was 4.52. Ocular AEs were reported in more patients in the dexamethasone than in the ranibizumab group (86.6% vs 55.6%). Using the European labels, similar efficacy was observed for ranibizumab and dexamethasone at months 1 and 2. However, ranibizumab maintained its efficacy throughout the study, whereas dexamethasone declined from month 3 onward. The main limitation of the study was that dexamethasone patients received only a single treatment during the 6-month study. In clinical practice, dexamethasone retreatment may be required earlier than 6 months. Safety findings were similar to those previously reported. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. 29 CFR 1918.99 - Retention of DOT markings, placards and labels.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING General Working Conditions. § 1918.99 Retention of DOT markings, placards and labels. (a) Any employer who receives a package...

  16. Read the Label First: Protect Your Pets

    EPA Pesticide Factsheets

    Learn about the importance of reading pet products labels before purchasing and using any product to insure the safety of your pets. Find tips for ways to reduce the changes of pets accessing potentially dangerous products.

  17. Third year nursing students' viewpoints about circumstances which threaten safety in the clinical setting.

    PubMed

    Montgomery, Phyllis; Killam, Laura; Mossey, Sharolyn; Heerschap, Corey

    2014-02-01

    Evidence emphasizes that learners, educators, clinicians, programs, and organizations share the responsibility for establishing and maintaining safety throughout undergraduate nursing education. Increased knowledge about students' perceptions of threats to safety in the clinical setting may guide educators' efforts to promote the development of safe novice practitioners while preserving patient safety. The purpose of this study was to describe third year nursing students' viewpoints of the circumstances which threaten safety in the clinical setting. Using Q methodology, 34 third year Bachelor of Science in Nursing students sorted 43 theoretical statement cards. Each card identified a statement describing a threat to safety in the clinical setting. These statements were generated through a review of nursing literature and consultation with experts in nursing education. Centroid factor analysis and varimax rotation identified viewpoints regarding circumstances that most threaten safety. Three discrete viewpoints and one consensus perspective constituted students' description of threatened safety. The discrete viewpoints were labeled lack of readiness, misdirected practices, and negation of professional boundaries. There was consensus that it is most unsafe in the clinical setting when novices fail to consolidate an integrated cognitive, behavioral, and ethical identity. This unifying perspective was labeled non-integration. Third year nursing students and their educators are encouraged to be mindful of the need to ensure readiness prior to entry into the clinical setting. In the clinical setting, the learning of prepared students must be guided by competent educators. Finally, both students and their educators must respect professional boundaries to promote safety for students and patients. © 2013.

  18. Early intervention with tafamidis provides long-term (5.5-year) delay of neurologic progression in transthyretin hereditary amyloid polyneuropathy.

    PubMed

    Waddington Cruz, Márcia; Amass, Leslie; Keohane, Denis; Schwartz, Jeffrey; Li, Huihua; Gundapaneni, Balarama

    2016-09-01

    Transthyretin hereditary amyloid polyneuropathy, also traditionally known as transthyretin familial amyloid polyneuropathy (ATTR-FAP), is a rare, relentless, fatal hereditary disorder. Tafamidis, an oral, non-NSAID, highly specific transthyretin stabilizer, demonstrated safety and efficacy in slowing neuropathy progression in early-stage ATTRV30M-FAP in a 1.5-year, randomized, double-blind, placebo-controlled trial, and 1-year open-label extension study, with a second long-term open-label extension study ongoing. Subgroup analysis of the effectiveness of tafamidis in the pivotal study and its open-label extensions revealed a relatively cohesive cohort of patients with mild neuropathy (i.e. Neuropathy Impairment Score for Lower Limbs [NIS-LL] ≤ 10) at the start of active treatment. Early treatment with tafamidis for up to 5.5 years (≥1 dose of tafamidis meglumine 20 mg once daily during the original trial or after switching from placebo in its extension) resulted in sustained delay in neurologic progression and long-term preservation of nutritional status in this cohort. Mean (95% CI) changes from baseline in NIS-LL and mBMI were 5.3 (1.6, 9.1) points and -7.8 (-44.3, 28.8) kg/m 2 × g/L at 5.5 years, respectively. No new safety issues or side effects were identified. These data represent the longest prospective evaluation of tafamidis to date, confirm a favorable safety profile, and underscore the long-term benefits of early intervention with tafamidis. ClincalTrials.gov Identifier: NCT00409175, NCT00791492, and NCT00925002.

  19. 9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to..., and cholesterol in a product may only be made on the label or in labeling of products if: (1) The...

  20. 9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to..., and cholesterol in a product may only be made on the label or in labeling of products if: (1) The...

  1. 16 CFR 1500.134 - Policy on first aid labeling for saline emesis.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Policy on first aid labeling for saline... REGULATIONS § 1500.134 Policy on first aid labeling for saline emesis. (a) This section states the Consumer Product Safety Commission's policy concerning first aid instructions for the use of a salt solution to...

  2. 16 CFR § 1407.3 - Providing performance and technical data to purchasers by labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Providing performance and technical data to... TECHNICAL DATA BY LABELING § 1407.3 Providing performance and technical data to purchasers by labeling. (a... technical data related to performance and safety to prospective purchasers of such products at the time of...

  3. 16 CFR 1407.3 - Providing performance and technical data to purchasers by labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Providing performance and technical data to... TECHNICAL DATA BY LABELING § 1407.3 Providing performance and technical data to purchasers by labeling. (a... technical data related to performance and safety to prospective purchasers of such products at the time of...

  4. 16 CFR 1407.3 - Providing performance and technical data to purchasers by labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Providing performance and technical data to... TECHNICAL DATA BY LABELING § 1407.3 Providing performance and technical data to purchasers by labeling. (a... technical data related to performance and safety to prospective purchasers of such products at the time of...

  5. 16 CFR 1407.3 - Providing performance and technical data to purchasers by labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Providing performance and technical data to... TECHNICAL DATA BY LABELING § 1407.3 Providing performance and technical data to purchasers by labeling. (a... technical data related to performance and safety to prospective purchasers of such products at the time of...

  6. 16 CFR 1407.3 - Providing performance and technical data to purchasers by labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Providing performance and technical data to... TECHNICAL DATA BY LABELING § 1407.3 Providing performance and technical data to purchasers by labeling. (a... technical data related to performance and safety to prospective purchasers of such products at the time of...

  7. 16 CFR § 1102.6 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Background and Definitions § 1102.6 Definitions. (a... Database. (2) Commission or CPSC means the Consumer Product Safety Commission. (3) Consumer product means a... private labeler. (7) Publicly Available Consumer Product Safety Information Database, also referred to as...

  8. 16 CFR 1209.31 - Purpose and applicability.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 1209.31 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION Certification § 1209.31 Purpose and applicability. (a..., importers, and private labelers must follow to certify that their products comply with the Amended Interim...

  9. 78 FR 28733 - Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ... Toxicology Testing. Labeling (dose limits). Electromagnetic incompatibility........ Electromagnetic... analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless... electromagnetic compatibility performance, wireless performance, and electrical safety; and (4) Labeling must...

  10. A systematic review on the off-label use of montelukast in atopic dermatitis treatment.

    PubMed

    Chin, Weng Khong; Lee, Shaun Wen Huey

    2018-05-18

    Background Atopic dermatitis (AD) is the most common form of eczema. As leukotriene mediators are involved in the inflammatory phase of atopic dermatitis, montelukast has been suggested as a possible therapy. Aim of the review To evaluate the safety and efficacy of montelukast off-label use for the treatment atopic dermatitis. Method A search was performed from database inception until March 2018 in six electronic databases for randomized-controlled-trials examining the use of montelukast for AD. Results Among 301 articles screened, 11 studies met the inclusion criteria and were included in the review. The study populations consist of paediatric and adult subjects with moderate-to-severe AD. Montelukast use was shown to improve symptoms such as pruritus in four studies. Another 2 studies reported that montelukast could improve symptoms similar to the standard regimen of topical steroid and oral antihistamine. However, five studies reported that montelukast had no effects in symptoms alleviation. The use of montelukast was associated with a similar safety profile to placebo and well-tolerated with minimal adverse effects. Conclusion There is limited evidence to suggest that the off-label use of montelukast is effective in treating moderate-to-severe AD. Further research with larger study populations employing standardized endpoint measuring instrument is warranted to further investigate the off-label use of montelukast in AD treatment. Until then, the use of conventional treatments including optimal daily skin hydration should remain the mainstay in the management of atopic dermatitis. In fact, for moderate-to-severe condition, steroid sparing immune-suppressants should still be used clinically until more effective and safer alternative is discovered.

  11. Long-term safety and tolerability of rotigotine transdermal system in patients with early-stage idiopathic Parkinson's disease: a prospective, open-label extension study.

    PubMed

    Elmer, Lawrence W; Surmann, Erwin; Boroojerdi, Babak; Jankovic, Joseph

    2012-06-01

    This prospective, open-label extension (SP702; NCT00594165) of a 6-month double-blind, randomized study investigated the long-term safety and tolerability of rotigotine transdermal system in early Parkinson's disease (PD). Patients with early-stage idiopathic PD received transdermal rotigotine for up to 6 years at optimal dose (up to 16 mg/24h). Adjunctive levodopa was allowed. Primary outcomes included adverse events (AEs) and extent of rotigotine exposure. Other outcomes included time to levodopa, incidence of dyskinesias, and efficacy using the Unified Parkinson's Disease Rating Scale (UPDRS) II+III total score. Of 217 patients entering the open-label study, 47% were still in the study upon closure; 24% withdrew because of AEs and 6% because of lack of efficacy. The median exposure to rotigotine was 1910 days (≈ 5 years, 3 months; range 1-2188 days). Most common AEs were somnolence (23% per patient-year), falls (17%), peripheral edema (14%), nausea (12%), and application site reactions (ASRs; 12%). 3% withdrew because of ASRs. 26% patients did not initiate levodopa; of those who did, fewer than half started levodopa in the first year. Dyskinesias were reported by 25% patients; the majority (83%) reported their first episode after initiating levodopa. Mean UPDRS II+III total scores remained below double-blind baseline for up to 2 years of open-label treatment. This is the longest interventional study of rotigotine conducted to date. Transdermal rotigotine was generally well tolerated for up to 6 years; AEs reported were similar to those observed in shorter studies and led to discontinuation in only 24% patients. Copyright © 2012 Elsevier Ltd. All rights reserved.

  12. Evaluation of the anti-hyperglycemic effect and safety of microorganism 1-deoxynojirimycin.

    PubMed

    Takasu, Soo; Parida, Isabella Supardi; Onose, Shinji; Ito, Junya; Ikeda, Ryoichi; Yamagishi, Kenji; Higuchi, Oki; Tanaka, Fukuyo; Kimura, Toshiyuki; Miyazawa, Teruo; Nakagawa, Kiyotaka

    2018-01-01

    1-Deoxynojirimycin (DNJ) is a potent α-glucosidase inhibitor and thus beneficial for prevention of diabetes. While we have succeeded in obtaining the culture supernatant extract (CSE) rich in DNJ from microorganism source, information regarding its anti-hyperglycemic effect and safety were still limited. Therefore, this study was aimed to evaluate the anti-hyperglycemic effect and safety of microorganism DNJ. Oral sucrose tolerance test was performed, and the result showed that CSE was able to significantly suppress the blood glucose elevation and suggested DNJ as the main active compound. To determine its safety, the absorption and excretion of microorganism DNJ were evaluated using 15N labeling method. Our findings investigated the recovery rate of 15N from DNJ reached 80% up to 48 hours after oral administration, suggesting its rapid excretion, suggesting the safety of DNJ. This study verified the functional properties and safety of DNJ from microorganisms, suggesting its potential use for functional purpose.

  13. A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain.

    PubMed

    Arora, Samir; Setnik, Beatrice; Michael, Drass; Hudson, John D; Clemmer, Ray; Meisner, Paul; Pixton, Glenn C; Goli, Veeraindar; Sommerville, Kenneth W

    2014-01-01

    To evaluate the long-term safety of oxycodone-hydrochloride and sequestered naltrexone-hydrochloride (ALO-02) administered for up to 12 months. Open-label, single-arm safety study. Thirty-two US research centers (ClinicalTrials.gov identifier NCT01428583). Three hundred ninety-five adults (opioid experienced and opioid naïve) with moderate-to-severe chronic noncancer pain (CNCP). Open-label, oral ALO-02 capsules, daily dose ranging from 20 to 160 mg oxycodone for up to 12 months. Number and type of adverse events (AEs) and drugrelated AEs, including assessments of withdrawal (Clinical Opiate Withdrawal Scale; COWS), pharmacokinetics, efficacy, and aberrant behaviors (Current Opioid Misuse Measure). A total of 193 (48.9 percent) patients received ALO-02 for ≥181 days and 105 (26.6 percent) patients for ≥361 days. The most common treatment-emergent AEs were nausea (25.3 percent), constipation (21.3 percent), vomiting (13.9 percent), and headache (11.6 percent). The most common drug-related AEs were constipation (18.0 percent), nausea (14.9 percent), somnolence (8.4 percent), fatigue (6.8 percent), dizziness (5.6 percent), and vomiting (5.1 percent). A majority of patients (86.6 percent) had a maximum COWS total score below the level for mild withdrawal symptoms at every visit throughout the study. Pain severity scores as measured by the short Form of the Brief Pain Inventory (BPI-SF) decreased over time. Repeat dosing of ALO-02 for up to 12 months is safe and well tolerated in a CNCP population of both opioid-experienced and opioid-naïve patients. ALO-02 demonstrated a safety profile consistent with extended-release opioids and the expected analgesic efficacy. The addition of sequestered naltrexone had no significant clinical effect on patients when taken as directed.

  14. 9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to... level of fat, fatty acid, and cholesterol in a product may only be made on the label or in labeling of...

  15. 9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to... level of fat, fatty acid, and cholesterol in a product may only be made on the label or in labeling of...

  16. Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study.

    PubMed

    Ogata, Atsushi; Amano, Koichi; Dobashi, Hiroaki; Inoo, Masayuki; Ishii, Tomonori; Kasama, Tsuyoshi; Kawai, Shinichi; Kawakami, Atsushi; Koike, Tatsuya; Miyahara, Hisaaki; Miyamoto, Toshiaki; Munakata, Yasuhiko; Murasawa, Akira; Nishimoto, Norihiro; Ogawa, Noriyoshi; Ojima, Tomohiro; Sano, Hajime; Shi, Kenrin; Shono, Eisuke; Suematsu, Eiichi; Takahashi, Hiroki; Tanaka, Yoshiya; Tsukamoto, Hiroshi; Nomura, Akira

    2015-05-01

    To evaluate the longterm safety and efficacy of subcutaneous tocilizumab (TCZ-SC) as monotherapy in patients with rheumatoid arthritis (RA). Of 346 patients who received 24 weeks of double-blind treatment with either TCZ-SC monotherapy, 162 mg every 2 weeks (q2w); or intravenous TCZ (TCZ-IV) monotherapy, 8 mg/kg every 4 weeks; 319 patients continued to receive TCZ-SC q2w in the 84-week open-label extension (OLE) of the MUSASHI study (JAPICCTI-101117). Efficacy, safety, and immunogenicity were evaluated for all patients treated with TCZ during 108 weeks. The proportions of patients who achieved American College of Rheumatology 20/50/70 responses, low disease activity [28-joint Disease Activity Score (DAS28) ≤ 3.2], or remission (DAS28 < 2.6) at Week 24 were maintained until Week 108. The incidences of adverse events and serious adverse events were 498.3 and 16.9 per 100 patient-years (PY), respectively. The overall safety of TCZ-SC monotherapy was similar to that of TCZ-IV monotherapy. Rates of injection site reactions (ISR) through 108 weeks remained similar to rates through 24 weeks. ISR were mild and did not cause any patient withdrawals. No serious hypersensitivity events (including anaphylactic reactions) occurred. Anti-TCZ antibodies were present in 2.1% of patients treated with TCZ-SC monotherapy. TCZ-SC monotherapy maintained a favorable safety profile and consistent efficacy throughout the 108-week study. Like TCZ-IV, TCZ-SC could provide an additional treatment option for patients with RA.

  17. DNA barcoding detected improper labelling and supersession of crab food served by restaurants in India.

    PubMed

    Vartak, Vivek Rohidas; Narasimmalu, Rajendran; Annam, Pavan Kumar; Singh, Dhirendra P; Lakra, Wazir S

    2015-01-01

    Detection of improper labelling of raw and processed seafood is of global importance for reducing commercial fraud and enhancing food safety. Crabs are crustaceans with intricate morphological as well as genetic divergence among species and are popular as seafood in restaurants. Owing to the high number of crab species available, it can be difficult to identify those included in particular food dishes, thus increasing the chance of supersession. DNA barcoding is an advanced technology for detecting improper food labelling and has been used successfully to authenticate seafood. This study identified 11 edible crab species from India by classical taxonomy and developed molecular barcodes with the cytochrome c oxidase I (COI) gene. These barcodes were used as reference barcodes for detecting any improper labelling of 50 restaurant crab samples. Neighbour-joining tree analysis with COI barcodes showed distinct clusters of restaurant samples with respective reference species. The study demonstrated 100% improper labelling of restaurant samples to cover up acts of inferior crab supersession. DNA barcoding successfully identified 11 edible crabs in accordance with classical taxonomy and discerned improper crab food labelling in restaurants of India. © 2014 Society of Chemical Industry.

  18. Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH.

    PubMed

    Osman, Nadir I; Chapple, Christopher R; Tammela, Teuvo L; Eisenhardt, Andreas; Oelke, Matthias

    2015-05-01

    To evaluate the long-term safety (primary objective) and efficacy/impact on quality of life (QoL, secondary objectives) of silodosin 8 mg once daily in men with LUTS/BPH. Men who completed the 12-week double-blind study with silodosin 8 mg, tamsulosin 0.4 mg, or placebo were offered to continue with the 9-month open-label study during which all patients received silodosin 8 mg once daily. Safety was assessed by analysing vital signs, electrocardiograms, laboratory tests, and adverse events. Efficacy was evaluated with the International Prostate Symptom Score (IPSS), IPSS voiding and storage sub-scores, IPSS-QoL, and maximum urinary flow rate (Q max). A total of 500 patients (mean age 66 years) entered the 9-month open-label study. Treatment-emergent adverse events (TEAE) were experienced by 33.4% patients. Ejaculation dysfunction was the most common TEAE (9.0%) but led to study discontinuations in only 1.6% of patients. Dizziness without orthostatic hypotension occurred in 0.8%. A marked reduction in total IPSS (-2.7 ± 3.8) was documented at the first visit of this extension phase in patients having de novo silodosin compared with lesser improvement in patients previously treated with silodosin (-0.82 ± 4.2) or tamsulosin (-0.83 ± 3.8). Improvements were maintained throughout the open-label phase. QoL also improved, with the greatest improvement in de novo silodosin patients. No relevant changes in Q max occurred. Long-term treatment with silodosin was safe and efficacious. Abnormal ejaculation was the most common TEAE, but led to treatment discontinuation in only 1.6% of patients. Orthostatic hypotension was not seen, and only a few patients experienced dizziness.

  19. Efficacy and safety of once-weekly oral trelagliptin switched from once-daily dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes mellitus: An open-label, phase 3 exploratory study.

    PubMed

    Inagaki, Nobuya; Sano, Hiroki; Seki, Yoshifumi; Kuroda, Shingo; Kaku, Kohei

    2018-03-01

    Trelagliptin, a novel once-weekly oral dipeptidyl peptidase-4 (DPP-4) inhibitor, has shown favorable efficacy and safety in type 2 diabetes mellitus patients. Trelagliptin was launched in Japan, and is expected to be initially used for switchover from a daily DPP-4 inhibitor in the clinical setting. Thus, the present study was carried out to explore the efficacy and safety of trelagliptin after a daily DPP-4 inhibitor was switched to it. This was an open-label, phase 3 exploratory study to evaluate the efficacy and safety of trelagliptin in Japanese type 2 diabetes mellitus patients who had stable glycemic control on once-daily sitagliptin therapy. Eligible patients received trelagliptin 100 mg orally before breakfast once a week for 12 weeks. The primary end-point was blood glucose by the meal tolerance test, and additional end-points were glycemic control (efficacy) and safety. Altogether, 14 patients received the study drug. The blood glucose did not markedly change from baseline at major assessment points in the meal tolerance test, and a decrease in blood glucose was observed at several other assessment points. Adverse events were reported in 42.9% (6/14) of patients, but all adverse events were mild or moderate in severity, and most were not related to the study drug. No cases of death, serious adverse events or hypoglycemia were reported. It is considered possible to switch a once-daily DPP-4 inhibitor to trelagliptin in type 2 diabetes mellitus patients with stable glycemic control in combination with diet and exercise therapy without any major influences on glycemic control or safety. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  20. Cardiovascular Safety of Droxidopa in Patients With Symptomatic Neurogenic Orthostatic Hypotension.

    PubMed

    White, William B; Hauser, Robert A; Rowse, Gerald J; Ziemann, Adam; Hewitt, L Arthur

    2017-04-01

    The norepinephrine prodrug droxidopa improves symptoms of neurogenic orthostatic hypotension, a condition that is associated with diseases of neurogenic autonomic failure (e.g., Parkinson disease, multiple system atrophy, pure autonomic failure). These conditions are more prevalent in older patients who also have cardiovascular co-morbidities. Hence, we evaluated the cardiovascular safety of droxidopa in patients with symptomatic neurogenic orthostatic hypotension who participated in randomized controlled studies (short-term studies of 1 to 2 weeks and an intermediate 8- to 10-week study) and long-term open-label studies. Rates of cardiovascular adverse events (AEs) for patients treated with droxidopa were 4.4% in the intermediate study and 10.8% in the long-term open-label studies. Adjusting for exposure time, cardiovascular AE rates were 0.30 events/patient-year in the short-term and intermediate studies and 0.15 events/patient-year in the long-term open-label studies. The incidence of treatment discontinuation due to blood pressure-related events was approximately 2.5%. Among patients with a history of cardiac disorders at baseline, the rates of cardiovascular-related and blood pressure-related AEs were nominally higher with droxidopa compared to placebo. Most of these events were minor atrial arrhythmias; none were major adverse cardiovascular events or deaths. In conclusion, small increases in cardiovascular AEs were observed with droxidopa compared to placebo; this was most evident in patients with preexisting cardiac disorders. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  1. Meat and Poultry Labeling Terms

    MedlinePlus

    ... Forms Standard Forms FSIS United States Department of Agriculture Food Safety and Inspection Service About FSIS District ... USDA's Food Safety and Inspection Service and the Agriculture Marketing Service have officially evaluated a meat product ...

  2. Bacterial quality and safety of packaged fresh leafy vegetables at the retail level in Finland.

    PubMed

    Nousiainen, L-L; Joutsen, S; Lunden, J; Hänninen, M-L; Fredriksson-Ahomaa, M

    2016-09-02

    Consumption of packaged fresh leafy vegetables, which are convenient ready-to-eat products, has increased during the last decade. The number of foodborne outbreaks associated with these products has concurrently increased. In our study, (1) label information, (2) O2/CO2 composition, (3) bacterial quality and (4) safety of 100 fresh leafy vegetables at the retail level were studied in Finland during 2013. Bacterial quality was studied using aerobic bacteria (AB) and coliform bacteria (CB) counts, and searching for the presence of Escherichia coli, Listeria and Yersinia. The safety was studied by the presence of Salmonella, ail-positive Yersinia, stx-positive E. coli (STEC) and Listeria monocytogenes using PCR and culturing. Important label information was unavailable on several packages originating from different companies. The packaging date was missing on all packages and the date of durability on 83% of the packages. Storage temperature was declared on 62% of the packages and 73% of the packages contained information about prewashing. The batch/lot number was missing on 29% of the packages. Very low oxygen (O2) (<1%) and elevated carbon dioxide (CO2) (2-22%) concentrations were measured in all packages labelled to contain a protective atmosphere. O2 and CO2 concentrations varied widely in the rest of the packages. AB and CB counts were high in the leafy vegetable samples varying between 6.2 and 10.6 and 4.2-8.3logcfu/g, respectively. In most of the samples, the AB and CB counts exceeded 10(8) and 10(6)cfu/g, respectively. A positive correlation was observed between the AB and CB counts. E. coli was isolated from 15% of the samples and Yersinia from 33%. L. monocytogenes was isolated from two samples and ail-positive Y. enterocolitica in one. Using PCR, STEC was detected in seven samples, and Salmonella and ail-positive Y. enterocolitica in two samples each. The AB and CB mean values of products originating from different companies varied widely. High AB and CB counts and pathogenic bacteria were detected in ready-to-eat products not needing washing before use. Our study shows that the bacterial quality and safety of packaged fresh leafy vegetables is poor and label information on the packages is inadequate. More studies are needed concerning the impact of a protective atmosphere on bacterial growth, and the impact of washing for removing bacteria. Copyright © 2016 Elsevier B.V. All rights reserved.

  3. Encouraging Maternal Sacrifice: How Regulations Governing the Consumption of Pharmaceuticals During Pregnancy Prioritize Fetal Safety over Maternal Health and Autonomy.

    PubMed

    Donley, Greer

    Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as "vulnerable" and thus precludes them from most medical research. The result is that ninety-one percent of drugs lack any reliable safety information for pregnant consumers. The latter currently requires all drug labels to encourage drug avoidance during pregnancy, despite ample evidence that avoiding needed medications can harm pregnant women. On June 30, 2015, new pregnancy labeling regulations took effect. Though these regulations make important improvements, they continue to treat pregnant women unlike any population, including other unique subpopulations, such as children. As a result, the new regulations do not fix the problem of over-warning pregnant women about the risks of drug consumption. This article questions the legitimacy of both regulations and suggests three reforms for how to improve access to vital safety information: (1) amend the regulations governing ethical research in human subjects to reclassify pregnant women as non-vulnerable adults; (2) create incentives to generate safety data in pregnant women by granting a period of market exclusivity for drug companies that invest in this research; and (3) make the FDA pregnancy labeling regulations consistent with the routine FDA practice of requiring the display of balanced, human data on risk.

  4. Patient safety in the clinical laboratory: a longitudinal analysis of specimen identification errors.

    PubMed

    Wagar, Elizabeth A; Tamashiro, Lorraine; Yasin, Bushra; Hilborne, Lee; Bruckner, David A

    2006-11-01

    Patient safety is an increasingly visible and important mission for clinical laboratories. Attention to improving processes related to patient identification and specimen labeling is being paid by accreditation and regulatory organizations because errors in these areas that jeopardize patient safety are common and avoidable through improvement in the total testing process. To assess patient identification and specimen labeling improvement after multiple implementation projects using longitudinal statistical tools. Specimen errors were categorized by a multidisciplinary health care team. Patient identification errors were grouped into 3 categories: (1) specimen/requisition mismatch, (2) unlabeled specimens, and (3) mislabeled specimens. Specimens with these types of identification errors were compared preimplementation and postimplementation for 3 patient safety projects: (1) reorganization of phlebotomy (4 months); (2) introduction of an electronic event reporting system (10 months); and (3) activation of an automated processing system (14 months) for a 24-month period, using trend analysis and Student t test statistics. Of 16,632 total specimen errors, mislabeled specimens, requisition mismatches, and unlabeled specimens represented 1.0%, 6.3%, and 4.6% of errors, respectively. Student t test showed a significant decrease in the most serious error, mislabeled specimens (P < .001) when compared to before implementation of the 3 patient safety projects. Trend analysis demonstrated decreases in all 3 error types for 26 months. Applying performance-improvement strategies that focus longitudinally on specimen labeling errors can significantly reduce errors, therefore improving patient safety. This is an important area in which laboratory professionals, working in interdisciplinary teams, can improve safety and outcomes of care.

  5. 33 CFR 150.628 - How must the operator label, tag, and mark a container of hazardous material?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Workplace Safety and Health Hazard Communication Program § 150.628 How must the operator label, tag, and..., reactive and other special condition hazard warnings. The only exception is for portable containers that...

  6. 16 CFR 503.2 - Status of specific items under the Fair Packaging and Labeling Act.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... (wooden, plastic). Compacts and mirrors. Diaries and calendars. Flower seeds. Footwear. Garden tools. Gift... gloves (household). Safety flares. Safety pins. School supplies. Sewing accessories. Silverware...

  7. 16 CFR 503.2 - Status of specific items under the Fair Packaging and Labeling Act.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... (wooden, plastic). Compacts and mirrors. Diaries and calendars. Flower seeds. Footwear. Garden tools. Gift... gloves (household). Safety flares. Safety pins. School supplies. Sewing accessories. Silverware...

  8. Schoolchildren, Governmentality and National E-Safety Policy Discourse

    ERIC Educational Resources Information Center

    Hope, Andrew

    2015-01-01

    The introduction of widespread school Internet access in industrialised countries has been accompanied by the materialisation of what can be labelled as a national school e-safety agenda. Drawing upon Foucault's notions of discourse and governmentality, this paper explores how e-safety policy documents serve to constrain the conceptual…

  9. Safety assessment in pediatric studies.

    PubMed

    Koren, Gideon; Elzagallaai, Abdelbasset; Etwel, Fatma

    2011-01-01

    It typically takes many years before an association of a drug with a rare, serious adverse reaction is established. As related to pediatric drug use, evidence is even more erratic, as most drugs are used off labels. To enhance child safety, there is an urgent need to develop robust and rapid methods to identify such associations in as timely a manner as possible. In this chapter, several novel methods, both clinically based pharmacoepidemiological approaches and laboratory-based methods, are described.

  10. Early intervention with tafamidis provides long-term (5.5-year) delay of neurologic progression in transthyretin hereditary amyloid polyneuropathy

    PubMed Central

    Waddington Cruz, Márcia; Amass, Leslie; Keohane, Denis; Schwartz, Jeffrey; Li, Huihua; Gundapaneni, Balarama

    2016-01-01

    Abstract Transthyretin hereditary amyloid polyneuropathy, also traditionally known as transthyretin familial amyloid polyneuropathy (ATTR-FAP), is a rare, relentless, fatal hereditary disorder. Tafamidis, an oral, non-NSAID, highly specific transthyretin stabilizer, demonstrated safety and efficacy in slowing neuropathy progression in early-stage ATTRV30M-FAP in a 1.5-year, randomized, double-blind, placebo-controlled trial, and 1-year open-label extension study, with a second long-term open-label extension study ongoing. Subgroup analysis of the effectiveness of tafamidis in the pivotal study and its open-label extensions revealed a relatively cohesive cohort of patients with mild neuropathy (i.e. Neuropathy Impairment Score for Lower Limbs [NIS-LL] ≤ 10) at the start of active treatment. Early treatment with tafamidis for up to 5.5 years (≥1 dose of tafamidis meglumine 20 mg once daily during the original trial or after switching from placebo in its extension) resulted in sustained delay in neurologic progression and long-term preservation of nutritional status in this cohort. Mean (95% CI) changes from baseline in NIS-LL and mBMI were 5.3 (1.6, 9.1) points and −7.8 (−44.3, 28.8) kg/m2 × g/L at 5.5 years, respectively. No new safety issues or side effects were identified. These data represent the longest prospective evaluation of tafamidis to date, confirm a favorable safety profile, and underscore the long-term benefits of early intervention with tafamidis. Trial Registration: ClincalTrials.gov Identifier: NCT00409175, NCT00791492, and NCT00925002. PMID:27494299

  11. 21 CFR 500.52 - Use of terms such as “tonic”, “tone”, “toner”, or “conditioner” in the labeling of preparations...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... which the term is qualified in the labeling to reflect the product's intended use. (c) An article so... unless the use of the article under the conditions set forth in its labeling is generally recognized as safe and effective among experts qualified by scientific training and experience to evaluate the safety...

  12. Long-term efficacy and safety of lamotrigine monotherapy in Japanese and South Korean pediatric patients with newly diagnosed typical absence seizures: An open-label extension study.

    PubMed

    Yasumoto, Sawa; Ohtsuka, Yoko; Sato, Katsuaki; Kurata, Atsuyo; Numachi, Yotaro; Shimizu, Masahiro

    2018-05-31

    To investigate the efficacy and safety of long-term lamotrigine (LTG) monotherapy in Japanese and South Korean pediatric patients with newly diagnosed typical absence seizures. Six Japanese patients and one South Korean patient were enrolled in the extension phase of the study after completing the 12-week maintenance phase of an open-label clinical study of LTG monotherapy. During the extension phase, patients underwent efficacy and safety evaluation every 12 weeks. Of the seven patients, six patients completed the extension phase. The seizure-free rate confirmed by hyperventilation (HV)-electroencephalography ranged from 71.4% to 100.0% at each visit up to Week 168 of the extension phase. Similar effects were confirmed by HV-clinical signs and seizure diaries. Although no unexpected adverse events were observed, one Japanese patient was withdrawn from the extension phase due to mild drug-related rash developed 842 days after the start of LTG. Although the number of patients is limited, long-term LTG monotherapy appeared to be effective and generally well tolerated in Japanese and South Korean pediatric patients with typical absence seizures. Copyright © 2018 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.

  13. Parkinson's Patients with Dyskinesia Switched from Immediate Release Amantadine to Open‐label ADS‐5102

    PubMed Central

    Fahn, Stanley; Pahwa, Rajesh; Tanner, Caroline M.; Espay, Alberto J.; Trenkwalder, Claudia; Adler, Charles H.; Patni, Rajiv; Johnson, Reed

    2018-01-01

    Abstract Background ADS‐5102 (amantadine) extended release capsules (GOCOVRI™) are a treatment for dyskinesia in patients with Parkinson's disease (PD). ADS‐5102 reduced dyskinesia and OFF time in phase 3 controlled trials of up to six months. Amantadine immediate release (IR) is used for dyskinesia, but suboptimal durability and tolerability limit its clinical utility. Methods In an ongoing, open‐label, phase 3 study in the US and Western Europe (NCT02202551), patients with PD received 274 mg of ADS‐5102 (equivalent to 340 mg amantadine HCl) once daily at bedtime for up to two years. Study outcomes included safety and assessment of motor complications, as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS‐UPDRS) Part IV. This manuscript focuses on those patients switched to ADS‐5102 from amantadine IR. Results in two groups of patients who previously completed a randomized controlled trial (EASE LID or EASE LID 3) are also presented according to use of ADS‐5102 or placebo in that study before enrollment in the open‐label study. Results Change in MDS‐UPDRS Part IV at week 8 was –0.3 in the previous ADS‐5102 subgroup (n = 61), –3.4 in the previous placebo subgroup (n = 79), and –3.4 in the previous amantadine IR subgroup (n = 32). Effects were maintained to week 64. In the previous amantadine IR subgroup (mean treatment duration, 2.5 years), mean amantadine IR dose was 221 mg. Safety data were consistent with previous randomized controlled trials of ADS‐5102. Conclusion These open‐label data suggest ADS‐5102 provides incremental reduction from baseline in MDS‐UDPRS Part IV score in patients switched directly from amantadine IR, without exacerbating adverse events.

  14. Pilot Study of Droxidopa With Carbidopa in Adults With ADHD.

    PubMed

    Adler, Lenard A; Gorny, Stephen W

    2015-04-23

    We conducted a two-period (open-label and double-blind) pilot investigation of droxidopa, with and without carbidopa, for ADHD. Twenty adult ADHD patients received open-label droxidopa titrated from 200 to 600 mg 3 times per day (TID; Weeks 1-3), then open-label droxidopa plus carbidopa titrated from 25 or 50 mg TID (Weeks 4-6). In Weeks 7 to 8, patients were randomized to continued co-treatment or matching placebo substitution. Improvements in mean total Adult ADHD Investigator Symptom Report Scale (AISRS) scores were seen at Week 1 (p < .0001) and Week 3 (p < .0001). Improvements were maintained but not increased with carbidopa. Thirteen of 20 patients completed open-label treatment. In the double-blind period, mean total AISRS scores were similar between the co-treatment (n = 6) and placebo (n = 5) groups. No serious adverse events were reported. These preliminary findings indicate that droxidopa can improve adult ADHD symptoms. Further studies are warranted to examine the efficacy and safety of droxidopa in ADHD. © 2015 SAGE Publications.

  15. Commercial Economic Poisons Applicators Licensing Manual, Rough Draft.

    ERIC Educational Resources Information Center

    Michigan State Dept. of Agriculture, Lansing, Div. of Plant Industry.

    This pesticide manual gives information on types of pest management, labels and labeling of pesticide containers, safety, types of pesticides (including chapters on insecticides, fungicides, herbicides, and nematicides), spray equipment, identification of pests (including weeds, plant diseases, and vertebrates), and environmental considerations.…

  16. 16 CFR 1702.13 - Labeling and packaging samples.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Labeling and packaging samples. 1702.13 Section 1702.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION...

  17. 16 CFR 1702.13 - Labeling and packaging samples.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Labeling and packaging samples. 1702.13 Section 1702.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION...

  18. 16 CFR 1702.13 - Labeling and packaging samples.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Labeling and packaging samples. 1702.13 Section 1702.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION...

  19. 16 CFR 1702.13 - Labeling and packaging samples.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Labeling and packaging samples. 1702.13 Section 1702.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION...

  20. 9 CFR 355.36 - Obsolete labels.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Obsolete labels. 355.36 Section 355.36 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY... CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA; INSPECTION, CERTIFICATION, AND...

  1. 9 CFR 355.36 - Obsolete labels.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Obsolete labels. 355.36 Section 355.36 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY... CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA; INSPECTION, CERTIFICATION, AND...

  2. Safety and Outcomes of Open-Label Deferasirox Iron Chelation Therapy for Mucormycosis▿

    PubMed Central

    Spellberg, Brad; Andes, David; Perez, Mario; Anglim, Anne; Bonilla, Hector; Mathisen, Glenn E.; Walsh, Thomas J.; Ibrahim, Ashraf S.

    2009-01-01

    We sought to describe the safety profile of open-label, adjunctive deferasirox iron chelation therapy in eight patients with biopsy-proven mucormycosis. Deferasirox was administered for an average of 14 days (range, 7 to 21) at 5 to 20 mg/kg of body weight/day. The only adverse effects attributable to deferasirox were rashes in two patients. Deferasirox treatment was not associated with changes in renal or liver function, complete blood count, or transplant immunosuppressive levels. Thus, deferasirox appears safe as an adjunctive therapy for mucormycosis. PMID:19433555

  3. Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

    ClinicalTrials.gov

    2018-04-20

    Leukemia; Leukemia,Pediatric; Leukemia, Myleiod; Leukemia, Mylegenous, Chronic; Leukemia, Mylegenous, Accelerated; BCR-ABL Positive; Myeloproliferative Disorder; Bone Marrow Disease; Hematologic Diseases; Neoplastic Processes; Imatinib; Dasatinib; Enzyme Inhibitor; Protein Kinase Inhibitor

  4. The 5S lean method as a tool of industrial management performances

    NASA Astrophysics Data System (ADS)

    Filip, F. C.; Marascu-Klein, V.

    2015-11-01

    Implementing the 5S (seiri, seiton, seiso, seiketsu, and shitsuke) method is carried out through a significant study whose purpose to analyse and deployment the management performance in order to emphasize the problems and working mistakes, reducing waste (stationary and waiting times), flow transparency, storage areas by properly marking and labelling, establishing standards work (everyone knows exactly where are the necessary things), safety and ergonomic working places (the health of all employees). The study describes the impact of the 5S lean method implemented to storing, cleaning, developing and sustaining a production working place from an industrial company. In order to check and sustain the 5S process, it is needed to use an internal audit, called “5S audit”. Implementing the 5S methodology requires organization and safety of the working process, properly marking and labelling of the working place, and audits to establish the work in progress and to maintain the improved activities.

  5. How informative are open-label studies for youth with bipolar disorder? A meta-analysis comparing open-label versus randomized, placebo-controlled clinical trials.

    PubMed

    Biederman, Joseph; Petty, Carter R; Woodworth, K Yvonne; Lomedico, Alexandra; O'Connor, Katherine B; Wozniak, Janet; Faraone, Stephen V

    2012-03-01

    To examine the informativeness of open-label trials toward predicting results in subsequent randomized, placebo-controlled clinical trials of psychopharmacologic treatments for pediatric bipolar disorder. We searched journal articles through PubMed at the National Library of Medicine using bipolar disorder, mania, pharmacotherapy, treatment and clinical trial as keywords. This search was supplemented with scientific presentations at national and international scientific meetings and submitted manuscripts from our group. Selection criteria included (1) enrollment of children diagnosed with DSM-IV bipolar disorder; (2) prospective assessment of at least 3 weeks; (3) monotherapy of a pharmacologic treatment for bipolar disorder; (4) use of a randomized placebo-controlled design or an open-label design for the same therapeutic compound; and (5) repeated use of the Young Mania Rating Scale (YMRS) as an outcome. The following information and data were extracted from 14 studies: study design, name of medication, class of medication, dose of medication, sample size, age, sex, trial length, and YMRS mean and standard deviation baseline and follow-up scores. For both study designs, the pooled effect size was statistically significant (open-label studies, z = 8.88, P < .001; randomized placebo-controlled studies, z = 13.75, P < .001), indicating a reduction in the YMRS from baseline to endpoint in both study designs. In a meta-analysis regression, study design was not a significant predictor of mean change in the YMRS. We found similarities in the treatment effects between open-label and randomized placebo-controlled studies in youth with bipolar disorder indicating that open-label studies are useful predictors of the potential safety and efficacy of a given compound in the treatment of pediatric bipolar disorder. © Copyright 2012 Physicians Postgraduate Press, Inc.

  6. In vivo label-free photoacoustic microscopy of the anterior segment of the mouse eye

    NASA Astrophysics Data System (ADS)

    Rao, Bin; Hu, Song; Li, Li; Maslov, Konstantin; Wang, Lihong V.

    2010-02-01

    Both iris fluorescein angiography (IFA) and indocyanine green angiography (ICGA) provide ophthalmologists imaging tools in studying the microvasculature structure and hemodynamics of the anterior segment of the eye in normal and diseased status. However, a non-invasive, endogenous imaging modality is preferable for the monitoring of hemodynamics of the iris microvasculature. We investigated the in vivo, label-free ocular anterior segment imaging with photo-acoustic microscopy (PAM) in mouse eyes. We demonstrated the unique advantage of endogenous contrast that is not available in both IFA and ICGA. The laser radiation was maintained within the ANSI laser safety limit. The in vivo, label-free nature of our imaging technology has the potential for ophthalmic applications.

  7. 76 FR 35266 - Reports, Forms and Record Keeping Requirements; Agency Information Collection Activity Under OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-16

    ... ``Consolidated Child Restraint System Registration, Labeling and Defect Notification.'' (OMB Control Number: 2127... Traffic Safety Administration. Title: Consolidated Child Restraint System Registration, Labeling and... collection. Abstract: Child restraint manufacturers are required to provide an owner's registration card for...

  8. 16 CFR 1616.6 - Labeling requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Labeling requirements. 1616.6 Section 1616.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... items from agents or treatments which are known to cause significant deterioration of their flame...

  9. 16 CFR 1616.6 - Labeling requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Labeling requirements. 1616.6 Section 1616.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... items from agents or treatments which are known to cause significant deterioration of their flame...

  10. 16 CFR 1616.6 - Labeling requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Labeling requirements. 1616.6 Section 1616.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... items from agents or treatments which are known to cause significant deterioration of their flame...

  11. 16 CFR 1616.6 - Labeling requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Labeling requirements. 1616.6 Section 1616.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... items from agents or treatments which are known to cause significant deterioration of their flame...

  12. Open-label, multicentre safety study of vemurafenib in 3219 patients with BRAFV600 mutation-positive metastatic melanoma: 2-year follow-up data and long-term responders' analysis.

    PubMed

    Blank, Christian U; Larkin, James; Arance, Ana M; Hauschild, Axel; Queirolo, Paola; Del Vecchio, Michele; Ascierto, Paolo A; Krajsova, Ivana; Schachter, Jacob; Neyns, Bart; Garbe, Claus; Chiarion Sileni, Vanna; Mandalà, Mario; Gogas, Helen; Espinosa, Enrique; Hospers, Geke A P; Miller, Wilson H; Robson, Susan; Makrutzki, Martina; Antic, Vladan; Brown, Michael P

    2017-07-01

    The orally available BRAF kinase inhibitor vemurafenib is an effective and tolerable treatment option for patients with metastatic melanoma harbouring BRAF V600 mutations. We assessed the safety of vemurafenib in a large population of patients with few alternative treatment options; we report updated 2-year safety. This was an open-label, multicentre study of vemurafenib (960 mg bid) in patients with previously treated or untreated BRAF mutation-positive metastatic melanoma (cobas ® 4800 BRAF V600 Mutation Test). The primary end-point was safety; efficacy end-points were secondary. An exploratory analysis was performed to assess safety outcomes in patients with long duration of response (DOR) (≥12 or ≥24 months). After a median follow-up of 32.2 months (95% CI, 31.1-33.2 months), 3079/3219 patients (96%) had discontinued treatment. Adverse events (AEs) were largely consistent with previous reports; the most common all-grade treatment-related AEs were arthralgia (37%), alopecia (25%) and hyperkeratosis (23%); the most common grade 3/4 treatment-related AEs were squamous cell carcinoma of the skin (8%) and keratoacanthoma (8%). In the exploratory analysis, patients with DOR ≥12 months (n = 287) or ≥24 months (n = 133) were more likely to experience grade 3/4 AEs than the overall population. No new specific safety signals were observed with longer vemurafenib exposure. After 2 years' follow-up, safety was maintained in this large group of patients with BRAF V600 mutation-positive metastatic melanoma who are more representative of routine clinical practice than typical clinical trial populations. These data suggest that long-term vemurafenib treatment is effective and tolerable without the development of new safety signals. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Juvenile Animal Testing: Assessing Need and Use in the Drug Product Label.

    PubMed

    Baldrick, Paul

    2018-01-01

    Juvenile animal testing has become an established part of drug development to support safe clinical use in the human pediatric population and for eventual drug product label use. A review of European Paediatric Investigation Plan decisions showed that from 2007 to mid-2017, 229 drugs had juvenile animal work requested, almost exclusively incorporating general toxicology study designs, in rat (57.5%), dog (8%), mouse (4.5%), monkey (4%), pig (2%), sheep (1%), rabbit (1%), hamster (0.5%), and species not specified (21.5%). A range of therapeutic areas were found, but the most common areas were infectious diseases (15%), endocrinology (13.5%), oncology (13%), neurology (11%), and cardiovascular diseases (10%). Examination of major clinical indications within these therapeutic areas showed some level of consistency in the species of choice for testing and the pediatric age that required support. Examination of juvenile animal study findings presented in product labels raises questions around how useful the data are to allow prescribing the drug to a child. It is hopeful that the new ICH S11 guideline "Nonclinical Safety Testing in Support of Development of Pediatric Medicines" currently in preparation will aid drug developers in clarifying the need for juvenile animal studies as well as in promoting a move away from toxicology studies with a conventional design. This would permit more focused testing to examine identified areas of toxicity or safety concerns and clarify the presentation/interpretation of juvenile animal study findings for proper risk assessment by a drug prescriber.

  14. 49 CFR 575.301 - Vehicle labeling of safety rating information (applicable unless a vehicle is subject to § 575.302).

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... section. (2) The label must depict the star ratings for that vehicle as reported to the vehicle...,” “Front Seat,” “Rear Seat” and where applicable, “Not Rated” or “To Be Rated,” the star graphic indicating... size of 12 point. All remaining text and symbols on the label (including the star graphic specified in...

  15. 49 CFR 575.301 - Vehicle labeling of safety rating information (applicable unless a vehicle is subject to § 575.302).

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... section. (2) The label must depict the star ratings for that vehicle as reported to the vehicle...,” “Front Seat,” “Rear Seat” and where applicable, “Not Rated” or “To Be Rated,” the star graphic indicating... size of 12 point. All remaining text and symbols on the label (including the star graphic specified in...

  16. 49 CFR 575.301 - Vehicle labeling of safety rating information (applicable unless a vehicle is subject to § 575.302).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... section. (2) The label must depict the star ratings for that vehicle as reported to the vehicle...,” “Front Seat,” “Rear Seat” and where applicable, “Not Rated” or “To Be Rated,” the star graphic indicating... size of 12 point. All remaining text and symbols on the label (including the star graphic specified in...

  17. Safety in Academic Chemistry Laboratories: Volume 2. Accident Prevention for Faculty and Administrators, 7th Edition.

    ERIC Educational Resources Information Center

    American Chemical Society, Washington, DC.

    This book contains volume 2 of 2 and describes safety guidelines for academic chemistry laboratories to prevent accidents for college and university students. Contents include: (1) "Organizing for Accident Prevention"; (2) "Personal Protective Equipment"; (3) "Labeling"; (4) "Material Safety Data Sheets (MSDSs)"; (5) "Preparing for Medical…

  18. 16 CFR § 1101.13 - Public ability to ascertain readily identity of manufacturer or private labeler.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Information Subject to Notice and Analysis Provisions of Section 6... advance notice and analysis provisions of section 6(b)(1) apply only when a reasonable person receiving...

  19. 16 CFR 1101.13 - Public ability to ascertain readily identity of manufacturer or private labeler.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Information Subject to Notice and Analysis Provisions of Section 6(b... advance notice and analysis provisions of section 6(b)(1) apply only when a reasonable person receiving...

  20. 16 CFR 1101.13 - Public ability to ascertain readily identity of manufacturer or private labeler.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Information Subject to Notice and Analysis Provisions of Section 6(b... advance notice and analysis provisions of section 6(b)(1) apply only when a reasonable person receiving...

  1. 16 CFR 1101.13 - Public ability to ascertain readily identity of manufacturer or private labeler.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Information Subject to Notice and Analysis Provisions of Section 6(b... advance notice and analysis provisions of section 6(b)(1) apply only when a reasonable person receiving...

  2. 16 CFR 1101.13 - Public ability to ascertain readily identity of manufacturer or private labeler.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Information Subject to Notice and Analysis Provisions of Section 6(b... advance notice and analysis provisions of section 6(b)(1) apply only when a reasonable person receiving...

  3. Gluten-Free Diet Indications, Safety, Quality, Labels, and Challenges.

    PubMed

    Rostami, Kamran; Bold, Justine; Parr, Alison; Johnson, Matt W

    2017-08-08

    A gluten-free diet (GFD) is the safest treatment modality in patient with coeliac disease (CD) and other gluten-related disorders. Contamination and diet compliance are important factors behind persistent symptoms in patients with gluten related-disorders, in particular CD. How much gluten can be tolerated, how safe are the current gluten-free (GF) products, what are the benefits and side effects of GFD? Recent studies published in Nutrients on gluten-free products' quality, availability, safety, as well as challenges related to a GFD are discussed.

  4. Pemetrexed Continuation Maintenance in Patients with Nonsquamous Non-small Cell Lung Cancer: Review of Two East Asian Trials in Reference to PARAMOUNT

    PubMed Central

    Yang, James Chin-Hsin; Ahn, Myung-Ju; Nakagawa, Kazuhiko; Tamura, Tomohide; Barraclough, Helen; Enatsu, Sotaro; Cheng, Rebecca; Orlando, Mauro

    2015-01-01

    Purpose A recent phase III study (PARAMOUNT) demonstrated that pemetrexed continuation maintenance therapy is a new treatment paradigm for advanced nonsquamous non-small cell lung cancer (NSCLC). The majority of patients enrolled in PARAMOUNT were Caucasian (94%). We reviewed efficacy and safety data from two clinical trials, which enrolled East Asian (EA) patients, to supplement data from PARAMOUNT on pemetrexed continuation maintenance therapy in patients with nonsquamous NSCLC. Materials and Methods Study S110 was a phase II, multicenter, randomized, controlled, open-label trial in never-smoker, chemonaïve, EA patients (n=31) with locally advanced or metastatic nonsquamous NSCLC (n=27). Study JMII was a multicenter, open-label, single-arm, post-marketing, clinical trial in Japanese patients (n=109) with advanced nonsquamous NSCLC. PARAMOUNT was a multicenter, randomized, double-blind, placebo-controlled trial in patients with advanced nonsquamous NSCLC. Results In EA patients with nonsquamous NSCLC, the median progression-free survival (PFS) for pemetrexed continuation maintenance therapy was 4.04 months (95% confidence interval [CI], 3.22 to 5.29 months) in study S110 and 3.9 months (95% CI, 3.2 to 5.2 months) in study JMII. The median PFS for pemetrexed continuation maintenance therapy in PARAMOUNT was 4.1 months (95% CI, 3.2 to 4.6 months). Pemetrexed continuation maintenance therapy in EA patients in studies S110 and JMII did not lead to any unexpected safety events, and was consistent with PARAMOUNT’s safety profile. Conclusion The efficacy and safety data in the EA trials were similar to those in PARAMOUNT despite differences in patient populations and study designs. These data represent consistent evidence for pemetrexed continuation maintenance therapy in EA patients with advanced nonsquamous NSCLC. PMID:25410761

  5. Pemetrexed Continuation Maintenance in Patients with Nonsquamous Non-small Cell Lung Cancer: Review of Two East Asian Trials in Reference to PARAMOUNT.

    PubMed

    Yang, James Chin-Hsin; Ahn, Myung-Ju; Nakagawa, Kazuhiko; Tamura, Tomohide; Barraclough, Helen; Enatsu, Sotaro; Cheng, Rebecca; Orlando, Mauro

    2015-07-01

    A recent phase III study (PARAMOUNT) demonstrated that pemetrexed continuation maintenance therapy is a new treatment paradigm for advanced nonsquamous non-small cell lung cancer (NSCLC). The majority of patients enrolled in PARAMOUNT were Caucasian (94%). We reviewed efficacy and safety data from two clinical trials, which enrolled East Asian (EA) patients, to supplement data from PARAMOUNT on pemetrexed continuation maintenance therapy in patients with nonsquamous NSCLC. Study S110 was a phase II, multicenter, randomized, controlled, open-label trial in never-smoker, chemonaïve, EA patients (n=31) with locally advanced or metastatic nonsquamous NSCLC (n=27). Study JMII was a multicenter, open-label, single-arm, post-marketing, clinical trial in Japanese patients (n=109) with advanced nonsquamous NSCLC. PARAMOUNT was a multicenter, randomized, double-blind, placebo-controlled trial in patients with advanced nonsquamous NSCLC. In EA patients with nonsquamous NSCLC, the median progression-free survival (PFS) for pemetrexed continuation maintenance therapy was 4.04 months (95% confidence interval [CI], 3.22 to 5.29 months) in study S110 and 3.9 months (95% CI, 3.2 to 5.2 months) in study JMII. The median PFS for pemetrexed continuation maintenance therapy in PARAMOUNT was 4.1 months (95% CI, 3.2 to 4.6 months). Pemetrexed continuation maintenance therapy in EA patients in studies S110 and JMII did not lead to any unexpected safety events, and was consistent with PARAMOUNT's safety profile. The efficacy and safety data in the EA trials were similar to those in PARAMOUNT despite differences in patient populations and study designs. These data represent consistent evidence for pemetrexed continuation maintenance therapy in EA patients with advanced nonsquamous NSCLC.

  6. Simvastatin as an Adjunct to Conventional Therapy of Non-infectious Uveitis: A Randomized, Open-Label Pilot Study.

    PubMed

    Shirinsky, Ivan V; Biryukova, Anastasia A; Shirinsky, Valery S

    2017-12-01

    Statins have been shown to reduce ocular inflammation in animal models of uveitis and to prevent development of uveitis in observational studies. There have been no experimental human studies evaluating statins' efficacy and safety in uveitis. In this study, we aimed to investigate efficacy and safety of simvastatin in patients with uveitis. For this single-center, open-label, randomized study, we enrolled patients with acute non-infectious uveitis. The patients were randomized to receive 40 mg simvastatin per day for 2 months in addition to conventional treatment or conventional treatment alone. The studied outcomes were the rate of steroid-sparing control of ocular inflammation, measures of ocular inflammation, intraocular pressure, and visual acuity. Fifty patients were enrolled in the study. Twenty-five patients were randomly assigned to receive simvastatin with conventional treatment and 25 to conventional treatment alone. Simvastatin was associated with significantly higher rates of steroid-sparing ocular inflammation control, decrease in anterior chamber inflammation, and improvement in visual acuity. The treatment was well tolerated, no serious adverse effects were observed. Our findings suggest that statins may have therapeutic potential in uveitis. These results need to be confirmed in double-blind, randomized, controlled studies.

  7. Safety and utility of magnetic resonance imaging in patients with cardiac implantable electronic devices.

    PubMed

    Strom, Jordan B; Whelan, Jill B; Shen, Changyu; Zheng, Shuang Qi; Mortele, Koenraad J; Kramer, Daniel B

    2017-08-01

    Off-label magnetic resonance imaging (MRI) for patients with cardiac implantable electrical devices has been limited owing to concerns about safety and unclear diagnostic and prognostic utility. The purpose of this study was to define major and minor adverse events with off-label MRI scans. We prospectively evaluated patients with non-MRI-conditional cardiac implantable electrical devices referred for MRI scans under a strict clinical protocol. The primary safety outcome was incidence of major adverse events (loss of pacing, inappropriate shock or antitachycardia pacing, need for system revision, or death) or minor adverse events (inappropriate pacing, arrhythmias, power-on-reset events, heating at the generator site, or changes in device parameters at baseline or at 6 months). A total of 189 MRI scans were performed in 123 patients (63.1% [78] men; median age 70 ± 18.5 years; 56.9% [70] patients with implantable cardioverter-defibrillators; 33.3% [41] pacemaker-dependent patients) predominantly for brain or spinal conditions. A minority of scans (22.7% [43]) were performed for urgent or emergent indications. Major adverse events were rare: 1 patient with loss of pacing, no deaths, or system revisions (overall rate 0.5%; 95% confidence interval 0.01-2.91). Minor adverse events were similarly rare (overall rate 1.6%; 95% confidence interval 0.3-4.6). Nearly all studies (98.4% [186]) were interpretable, while 75.1% [142] were determined to change management according to the prespecified criteria. No clinically significant changes were observed in device parameters acutely after MRI or at 6 months as compared with baseline across all patient and device categories. Off-label MRI scans performed under a strict protocol demonstrated excellent short- and medium-term safety while providing interpretable imaging that frequently influenced clinical care. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  8. Safety and utility of magnetic resonance imaging in patients with cardiac implantable electronic devices

    PubMed Central

    Strom, Jordan B.; Whelan, Jill B.; Shen, Changyu; Zheng, Shuang Qi; Mortele, Koenraad J.; Kramer, Daniel B.

    2017-01-01

    BACKGROUND Off-label magnetic resonance imaging (MRI) for patients with cardiac implantable electrical devices has been limited owing to concerns about safety and unclear diagnostic and prognostic utility. OBJECTIVE The purpose of this study was to define major and minor adverse events with off-label MRI scans. METHODS We prospectively evaluated patients with non–MRI-conditional cardiac implantable electrical devices referred for MRI scans under a strict clinical protocol. The primary safety outcome was incidence of major adverse events (loss of pacing, inappropriate shock or antitachycardia pacing, need for system revision, or death) or minor adverse events (inappropriate pacing, arrhythmias, power-on-reset events, heating at the generator site, or changes in device parameters at baseline or at 6 months). RESULTS A total of 189 MRI scans were performed in 123 patients (63.1% [78] men; median age 70 ± 18.5 years; 37.0% [70] patients with implantable cardioverter-defibrillators; 21.8% [41] pacemaker-dependent patients) predominantly for brain or spinal conditions. A minority of scans (22.7% [43]) were performed for urgent or emergent indications. Major adverse events were rare: 1 patient with loss of pacing, no deaths, or system revisions (overall rate 0.5%; 95% confidence interval 0.01–2.91). Minor adverse events were similarly rare (overall rate 1.6%; 95% confidence interval 0.3–4.6). Nearly all studies (98.4% [186]) were interpretable, while 74.9% [142] were determined to change management according to the prespecified criteria. No clinically significant changes were observed in device parameters acutely after MRI or at 6 months as compared with baseline across all patient and device categories. CONCLUSION Off-label MRI scans performed under a strict protocol demonstrated excellent short- and medium-term safety while providing interpretable imaging that frequently influenced clinical care. PMID:28385671

  9. Efficacy and safety of luseogliflozin added to insulin therapy in Japanese patients with type 2 diabetes: a multicenter, 52-week, clinical study with a 16-week, double-blind period and a 36-week, open-label period.

    PubMed

    Seino, Yutaka; Sasaki, Takashi; Fukatsu, Atsushi; Imazeki, Hisae; Ochiai, Hidekazu; Sakai, Soichi

    2018-06-01

    To evaluate the efficacy and safety of luseogliflozin in Japanese patients with type 2 diabetes (T2D) inadequately controlled with insulin monotherapy. This 52-week multicenter study entailed a 16-week, double-blind period followed by a 36-week, open-label period. Patients were randomized to receive either luseogliflozin 2.5 mg (n = 159) or placebo (n = 74) during the double-blind period. All patients who entered the open-label period received luseogliflozin. Major efficacy endpoints included the changes from baseline in HbA1c, fasting plasma glucose (FPG), postprandial plasma glucose (PPG) and bodyweight. Safety assessments included adverse events, laboratory tests and vital signs. In the double-blind period, luseogliflozin significantly decreased HbA1c (-1.18%), FPG (-42.4 mg/dL), 2 hour PPG (-68.7 mg/dL) and bodyweight (-1.27 kg) compared with placebo (all p < .001); these reductions were maintained over 52 weeks. The changes from baseline at Week 52 were -1.00%, -35.1 mg/dL, -68.8 mg/dL and -1.81 kg, respectively (all p < .001). In the placebo group, favorable glycemic control and bodyweight reduction were also observed after switching to luseogliflozin. Most adverse events were mild in severity. During the double-blind period, the incidences of hypoglycemia were 20.8% and 13.5% in the luseogliflozin and placebo groups, respectively. During the 52 weeks of luseogliflozin treatment, the frequency of hypoglycemia was 33.3%, but no serious hypoglycemia occurred. The safety profile other than hypoglycemia was also acceptable. There were no new safety concerns about luseogliflozin added to insulin. Luseogliflozin added to insulin therapy significantly improved glycemic control with bodyweight reduction and was well tolerated in Japanese patients with T2D. Japan Pharmaceutical Information Center (JapicCTI-142582).

  10. Open-label safety assessment of bilastine in elderly patients with allergic rhinoconjunctivitis and/or urticaria.

    PubMed

    Sologuren, Ander; Vinas, Rosa; Cordon, Esther; Riesgo, Susana E; Del Mar Fores, Maria; Senan, Maria Rosa; Fernandez, Sonia; Labeaga, Luis; Ruiz-Mijan, Manuel

    2018-03-20

    Bilastine is an H1-antihistamine approved for symptomatic treatment of patients with allergic rhinoconjunctivitis or urticaria. The safety profile of bilastine in clinical trials of allergic rhinoconjunctivitis or urticaria, assessed by type and frequency of adverse events (AE), was similar to that of placebo. As part of the risk management plan for bilastine, the safety profile of bilastine in the elderly was assessed. A prospective, multicenter, observational, open-label, 3-month follow-up study was performed to assess the safetyprofile of bilastine 20 mg in patients aged greater than or equal to 65 years with allergic rhinoconjunctivitis and/or urticaria. A total of 74 of 146 patients (50.7%) reported 129 treatment-emergent AEs (TEAE) during the study period. Theincidence of TEAEs was low, with monthly and quarterly rates of 0.29 (95% confidence intervals [CI], 0.229-0.367) and 0.88(95% CI, 0.688 -1.100), respectively. Monthly and quarterly incidence rates were 0.04 (95% CI, 0.016-0.082) and 0.12 (95%CI, 0.048-0.246), respectively, for related TEAEs (eight TEAEs in seven patients) and were 0.02 (95% CI, 0.003- 0.048) and0.05 (95% CI, 0.010-0.143), respectively, for serious TEAEs (five TEAES in three patients). All serious TEAEs were considered to be unrelated to bilastine. Bilastine 20 mg showed a favorable safety profile with a low incidence of TEAEs in patients aged greater than or equal to 65 years.The results were in accordance with the known safety profile of bilastine 20 mg and incidence of AEs reported in previous studies and described in the approved summary of product characteristics.

  11. Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study.

    PubMed

    Olde Rikkert, Marcel G M; Verhey, Frans R; Blesa, Rafael; von Arnim, Christine A F; Bongers, Anke; Harrison, John; Sijben, John; Scarpini, Elio; Vandewoude, Maurits F J; Vellas, Bruno; Witkamp, Renger; Kamphuis, Patrick J G H; Scheltens, Philip

    2015-01-01

    The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration (Souvenir I and Souvenir II) showed that memory performance was improved in drug-naïve mild AD patients, whereas no effects on cognition were observed in a 24-week RCT (S-Connect) in mild to moderate AD patients using AD medication. Souvenaid was well-tolerated in all RCTs. In this 24-week open-label extension (OLE) study to the 24-week Souvenir II RCT, long-term safety and intake adherence of the medical food Souvenaid was evaluated. Patients with mild AD (n = 201) received Souvenaid once-daily during the OLE. Main outcome parameters were safety and product intake adherence. The memory domain z-score from a revised neuropsychological test battery was continued as exploratory parameter. Compared to the RCT, a similar (low) incidence and type of adverse events was observed, being mainly (68.3%) of mild intensity. Pooled data (RCT and OLE) showed that 48-week use of Souvenaid was well tolerated with high intake adherence (96.1%). Furthermore, a significant increase in the exploratory memory outcome was observed in both the active-active and control-active groups during Souvenaid intervention. Souvenaid use for up to 48-weeks was well tolerated with a favorable safety profile and high intake adherence. The findings in this OLE study warrant further investigation toward the long-term safety and efficacy of Souvenaid in a well-controlled, double-blind RCT.

  12. 16 CFR 1615.5 - Labeling requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Labeling requirements. 1615.5 Section 1615.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... to protect the items from agents or treatments which are known to cause deterioration of their flame...

  13. 16 CFR § 1615.5 - Labeling requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Labeling requirements. § 1615.5 Section § 1615.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS... precautionary instructions to protect the items from agents or treatments which are known to cause deterioration...

  14. 16 CFR § 1616.6 - Labeling requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Labeling requirements. § 1616.6 Section § 1616.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS... instructions to protect the items from agents or treatments which are known to cause significant deterioration...

  15. 16 CFR 1615.5 - Labeling requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Labeling requirements. 1615.5 Section 1615.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... to protect the items from agents or treatments which are known to cause deterioration of their flame...

  16. 16 CFR 1615.5 - Labeling requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Labeling requirements. 1615.5 Section 1615.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... to protect the items from agents or treatments which are known to cause deterioration of their flame...

  17. 10 CFR 39.31 - Labels, security, and transportation precautions.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Labels, security, and transportation precautions. 39.31 Section 39.31 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL... explosion or fire. (2) The licensee shall lock and physically secure the transport package containing...

  18. 10 CFR 39.31 - Labels, security, and transportation precautions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Labels, security, and transportation precautions. 39.31 Section 39.31 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL... explosion or fire. (2) The licensee shall lock and physically secure the transport package containing...

  19. 10 CFR 39.31 - Labels, security, and transportation precautions.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Labels, security, and transportation precautions. 39.31 Section 39.31 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL... explosion or fire. (2) The licensee shall lock and physically secure the transport package containing...

  20. 16 CFR § 1702.13 - Labeling and packaging samples.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Labeling and packaging samples. § 1702.13 Section § 1702.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS...

  1. 9 CFR 317.9 - Labeling of equine products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of equine products. 317.9 Section 317.9 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY...

  2. 9 CFR 355.34 - Labels, approval of, by Administrator.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Labels, approval of, by Administrator. 355.34 Section 355.34 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... INSPECTION AND CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA; INSPECTION...

  3. Off-label prescribing patterns of antiemetics in children: a multicenter study in Italy.

    PubMed

    Zanon, Davide; Gallelli, Luca; Rovere, Francesca; Paparazzo, Rossella; Maximova, Natalia; Lazzerini, Marzia; Reale, Antonio; Corsetti, Tiziana; Renna, Salvatore; Emanueli, Tullia; Mannelli, Francesco; Manteghetti, Francesco; Da Dalt, Liviana; Palleria, Caterina; Banchieri, Nicola; Urbino, Antonio; Miglietta, Mario; Cardoni, Giovanni; Pompilio, Adriana; Arrighini, Alberto; Lazzari, Clara; Messi, Gianni

    2013-03-01

    Acute gastroenteritis (AG) represents both the main cause of acute vomiting in children under 3 years old and a major cause of access to the emergency department. Even if several drugs may be able to reduce the emesis, the pharmacological treatment of vomiting in children remains a controversial issue, and several drugs are prescribed outside their authorized drug label with respect dosage, age, indication, or route of administration and are named as off-label. The aim of present study was to assess the off-label use of antiemetic drugs in patients less than 18 years with vomiting related to AG. This study was carried out in eight pediatric emergency departments in Italy. The following data were obtained crossing the pharmacy distribution records with emergency departments' patient data: sex and age of the patients and detailed information for each drug used (indication, dose, frequency, and route of administration). We recorded that antiemetic drugs were prescribed in every year, particularly in children up to 2 years old, and compared with both literature data and data sheet; 30 % of the administered antiemetics were used off-label. In particular, domperidone was the only antiemetic used labeled for AG treatment in pediatric patients, while metoclopramide and ondansetron have been off-label for both age and indications (i.e., AG treatment). In conclusion, we documented an off-label use of antiemetics in children, and this could represents a problem of safety for the patient and a legal risk for the prescribing physician if patients have an unwanted or bad outcome from treatment.

  4. Budesonide MMX for the Induction of Remission of Mild to Moderate Ulcerative Colitis: A Pooled Safety Analysis.

    PubMed

    Lichtenstein, Gary R; Travis, Simon; Danese, Silvio; D'Haens, Geert; Moro, Luigi; Jones, Richard; Huang, Michael; Ballard, E David; Bagin, Robert; Hardiman, Yun; Collazo, Raul; Sandborn, William J

    2015-09-01

    Cumulative safety and tolerability of budesonide MMX, a once-daily oral corticosteroid for inducing mild to moderate ulcerative colitis remission, was examined. Data from three randomized, double-blind, placebo-controlled, phase II or III studies [budesonide MMX 9 mg, 6 mg, or 3mg for 8 weeks]; one phase II study [randomisation to budesonide MMX 9 mg or placebo for 4 weeks, then open-label budesonide MMX 9 mg for 4 weeks]; and one open-label study [budesonide MMX 9 mg for 8 weeks] were pooled. Patients randomised to budesonide MMX 9 mg [n = 288], 6 mg [n = 254], or placebo [n = 293] had similar rates of adverse events [AEs] [27.1%, 24.8%, and 23.9%, respectively] and serious AEs [2.4%, 2.0%, and 2.7%, respectively]; treatment-related AEs and serious AEs were reported by 11.8% and 13.5%, and 5.9% and 2.2%, respectively, of patients receiving budesonide MMX 3mg [n = 17] or open-label budesonide MMX 9 mg [n = 89]. Mean morning plasma cortisol concentrations were normal from baseline to final visit across randomised groups; in patients receiving open-label budesonide, mean cortisol concentration was 129.9 nmol/l after 4 weeks, returning to normal concentrations at final visit. Budesonide MMX was not associated with an overall increased risk for glucocorticoid-related adverse effects. Budesonide MMX 9 mg was associated with normal mean cortisol concentrations at final visit and an AE incidence comparable to placebo. Overall, budesonide MMX was safe and well tolerated for inducing remission of patients with mild to moderate ulcerative colitis. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  5. Budesonide MMX for the Induction of Remission of Mild to Moderate Ulcerative Colitis: A Pooled Safety Analysis

    PubMed Central

    Travis, Simon; Danese, Silvio; D’Haens, Geert; Moro, Luigi; Jones, Richard; Huang, Michael; Ballard, E. David; Bagin, Robert; Hardiman, Yun; Collazo, Raul; Sandborn, William J.

    2015-01-01

    Background and aims: Cumulative safety and tolerability of budesonide MMX, a once-daily oral corticosteroid for inducing mild to moderate ulcerative colitis remission, was examined. Methods: Data from three randomized, double-blind, placebo-controlled, phase II or III studies [budesonide MMX 9mg, 6mg, or 3mg for 8 weeks]; one phase II study [randomisation to budesonide MMX 9mg or placebo for 4 weeks, then open-label budesonide MMX 9mg for 4 weeks]; and one open-label study [budesonide MMX 9mg for 8 weeks] were pooled. Results: Patients randomised to budesonide MMX 9mg [n = 288], 6mg [n = 254], or placebo [n = 293] had similar rates of adverse events [AEs] [27.1%, 24.8%, and 23.9%, respectively] and serious AEs [2.4%, 2.0%, and 2.7%, respectively]; treatment-related AEs and serious AEs were reported by 11.8% and 13.5%, and 5.9% and 2.2%, respectively, of patients receiving budesonide MMX 3mg [n = 17] or open-label budesonide MMX 9mg [n = 89]. Mean morning plasma cortisol concentrations were normal from baseline to final visit across randomised groups; in patients receiving open-label budesonide, mean cortisol concentration was 129.9 nmol/l after 4 weeks, returning to normal concentrations at final visit. Budesonide MMX was not associated with an overall increased risk for glucocorticoid-related adverse effects. Conclusions: Budesonide MMX 9mg was associated with normal mean cortisol concentrations at final visit and an AE incidence comparable to placebo. Overall, budesonide MMX was safe and well tolerated for inducing remission of patients with mild to moderate ulcerative colitis. PMID:26094251

  6. 75 FR 1274 - Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... safety warning for use of hyaluronate sodium injectable solution in horses. DATES: This rule is effective... human food safety warning on product labeling. The supplemental NADA is approved as of December 11, 2009...

  7. An Interactive User Interface for Drug Labeling to Improve Readability and Decision-Making

    PubMed Central

    Abedtash, Hamed; Duke, Jon D.

    2015-01-01

    FDA-approved prescribing information (also known as product labeling or labels) contain critical safety information for health care professionals. Drug labels have often been criticized, however, for being overly complex, difficult to read, and rife with overwarning, leading to high cognitive load. In this project, we aimed to improve the usability of drug labels by increasing the ‘signal-to-noise ratio’ and providing meaningful information to care providers based on patient-specific comorbidities and concomitant medications. In the current paper, we describe the design process and resulting web application, known as myDrugLabel. Using the Structured Product Label documents as a base, we describe the process of label personalization, readability improvements, and integration of diverse evidence sources, including the medical literature from PubMed, pharmacovigilance reports from FDA adverse event reporting system (FAERS), and social media signals directly into the label. PMID:26958158

  8. An Interactive User Interface for Drug Labeling to Improve Readability and Decision-Making.

    PubMed

    Abedtash, Hamed; Duke, Jon D

    FDA-approved prescribing information (also known as product labeling or labels) contain critical safety information for health care professionals. Drug labels have often been criticized, however, for being overly complex, difficult to read, and rife with overwarning, leading to high cognitive load. In this project, we aimed to improve the usability of drug labels by increasing the 'signal-to-noise ratio' and providing meaningful information to care providers based on patient-specific comorbidities and concomitant medications. In the current paper, we describe the design process and resulting web application, known as myDrugLabel. Using the Structured Product Label documents as a base, we describe the process of label personalization, readability improvements, and integration of diverse evidence sources, including the medical literature from PubMed, pharmacovigilance reports from FDA adverse event reporting system (FAERS), and social media signals directly into the label.

  9. Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study.

    PubMed

    Arzimanoglou, Alexis; Ferreira, Jose A; Satlin, Andrew; Mendes, Shannon; Williams, Betsy; Critchley, David; Schuck, Edgar; Hussein, Ziad; Kumar, Dinesh; Dhadda, Shobha; Bibbiani, Francesco

    2016-05-01

    A good knowledge of safety and age group-specific pharmacokinetics (PK) of antiepileptic drugs (AEDs) in young pediatric patients is of great importance in clinical practice. This paper presents 6-month interim safety and PK from an ongoing 2-year open-label study (Study 303) of adjunctive rufinamide treatment in pediatric subjects ≥ 1 to < 4 years with inadequately controlled epilepsies of the Lennox-Gastaut syndrome (LGS) spectrum. Subjects (N = 37) were randomized to either rufinamide or any other approved AED chosen by the investigator as adjunctive therapy to the subject's existing regimen of 1-3 AEDs. Interim safety results showed that treatment-emergent adverse events (TEAEs) were similar between the rufinamide (22 [88.0%]) and any-other-AED group (9 [81.8%]), with most events considered mild or moderate. A population PK analysis was conducted including plasma rufinamide concentrations from Study 303 and two other study populations of LGS subjects ≥ 4 years. The rufinamide PK profile was dose independent. The apparent clearance (CL/F) estimated from the PK model was 2.19 L/h; it was found to increase significantly as a function of body weight. Coadministration of valproic acid significantly decreased rufinamide CL/F. CL/F was not significantly affected by other concomitant AEDs, age, gender, race, hepatic function, or renal function. No adjustments to body weight-based rufinamide dosing in subjects ≥ 1 to < 4 years are necessary. Rufinamide was safe and well tolerated in these pediatric subjects. Results from the interim analysis demonstrate that rufinamide's safety and PK profile is comparable in subjects ≥ 1 to < 4 and ≥ 4 years with LGS. Study 303 (clinicaltrials.gov: NCT01405053). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. Switching From Donepezil to Rivastigmine Is Well Tolerated: Results of an Open-Label Safety and Tolerability Study

    PubMed Central

    Sadowsky, Carl H.; Farlow, Martin R.; Atkinson, Leone; Steadman, Jennifer; Koumaras, Barbara; Chen, Michael; Mirski, Dario

    2005-01-01

    Background: Transitioning patients between cholinesterase inhibitors was thought to require a washout period to avoid cholinergic toxicity; however, evidence suggests that abrupt discontinuation of donepezil may lead to cognitive decline. We evaluated the safety and tolerability of an immediate switch from donepezil to rivastigmine. Method: This is an analysis of the safety and tolerability data from the first 28 days of an open-label, multicenter, prospective trial, conducted from August 2002 to August 2003, in which patients satisfying NINCDS-ADRDA criteria for probable Alzheimer's disease were administered rivastigmine 1.5 mg b.i.d. within 24 to 36 hours of donepezil discontinuation. Results are compared with adverse event rates from a retrospective analysis of a pivotal, placebo-controlled trial examining patients not previously treated with a cholinesterase inhibitor. Results: Fifty-eight of 61 patients completed the first 28 days, with no suspected drug-related discontinuations during this period. Incidence of overall gastrointestinal adverse events at day 7 was 8.2%, and at day 28 was 11.5%. The corresponding rate for rivastigmine-treated patients in the retrospective analysis of the pivotal trial for day 7 was 3.3%. Conclusion: These study results suggest that transitioning patients from donepezil to rivastigmine without a washout period is safe and well tolerated. PMID:15841194

  11. Unlicensed and off-label use of drugs in pediatric surgical units at tertiary care hospitals of Pakistan.

    PubMed

    Aamir, Muhammad; Khan, Jamshaid Ali; Shakeel, Faisal; Asim, Syed Muhammad

    2017-08-01

    Background Unlicensed and off-label prescribing practice is global dilemma around the world. This pioneering study was designed to determine unlicensed and off-label use of drug in surgical wards of tertiary care hospitals of Pakistan. Objective To assess unlicensed and off-label use of drugs in pediatric surgical unit at three tertiary care hospitals in Peshawar, Pakistan. Setting Two government and one private tertiary care hospitals in Pakistan. Method Drug profiles of 895 patients from three different clinical settings were evaluated for unlicensed and off-label use of drugs using Micromedex DRUGDEX. Main outcome measure Characteristics of the unlicensed and off-label drug prescriptions. Result Total of 3168 prescribed drugs were analyzed in this study. Indication (38.7%) and dose (34.8%) were the most frequent off-label categories. In comparison with the corresponding reference categories, infants and children, male patients and having less than five prescribed drugs were significant predictors of unlicensed prescriptions. In comparison with the corresponding reference categories, significant predictors of off-label drug prescribing were children younger than two year, children between 2-12 years, patient staying at hospital less than 5 days and patients having less than five prescribed drugs. Conclusion The prevalence of unlicensed and off-label drug prescriptions are high at pediatric surgical ward of tertiary care hospitals. More awareness of the efficacy and safety of drugs are required in pediatrics. In addition, new formulations with advanced dosing for children are also required to minimize the risk of adverse outcomes.

  12. 40 CFR 156.10 - Labeling requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

  13. 40 CFR 156.10 - Labeling requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

  14. 40 CFR 156.10 - Labeling requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

  15. 40 CFR 156.10 - Labeling requirements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

  16. 40 CFR 156.10 - Labeling requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

  17. 49 CFR 172.407 - Label specifications.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... one color background of green, red or blue. (ii) White must be used for the text and class number for... Hazardous Materials Safety, Office of Hazardous Materials Standards, Room 8422, Nassif Building, 400 Seventh... markings and hazard warning labels and placards: (i) For Red—Use PANTONE ® 186 U (ii) For Orange—Use...

  18. 10 CFR 39.31 - Labels, security, and transportation precautions.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Section 39.31 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL... radiation symbol specified in § 20.1901(a), without the conventional color requirements, and the wording.... The label must contain the radiation symbol specified in § 20.1901(a) of this chapter and the wording...

  19. 10 CFR 39.31 - Labels, security, and transportation precautions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Section 39.31 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL... radiation symbol specified in § 20.1901(a), without the conventional color requirements, and the wording.... The label must contain the radiation symbol specified in § 20.1901(a) of this chapter and the wording...

  20. 21 CFR 101.9 - Nutrition labeling of food.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Nutrition labeling of food. 101.9 Section 101.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD... (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint...

  1. 21 CFR 101.9 - Nutrition labeling of food.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Nutrition labeling of food. 101.9 Section 101.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD... (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint...

  2. 21 CFR 101.9 - Nutrition labeling of food.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Nutrition labeling of food. 101.9 Section 101.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD... (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint...

  3. 16 CFR 1500.15 - Labeling of fire extinguishers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Labeling of fire extinguishers. 1500.15 Section 1500.15 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT...)(1), the signal word “Danger” and the statement of hazard “Poisonous gases formed when used to...

  4. 9 CFR 381.132 - Labeling approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Labeling approval. 381.132 Section 381.132 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION...

  5. 9 CFR 381.133 - Generically approved labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Generically approved labeling. 381.133 Section 381.133 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCT...

  6. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and...

  7. 9 CFR 381.116 - Wording on labels of immediate containers.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Wording on labels of immediate containers. 381.116 Section 381.116 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... the container: Provided, however, That there is, immediately to the right or left of such principal...

  8. 9 CFR 381.116 - Wording on labels of immediate containers.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Wording on labels of immediate containers. 381.116 Section 381.116 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... the container: Provided, however, That there is, immediately to the right or left of such principal...

  9. 9 CFR 381.116 - Wording on labels of immediate containers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Wording on labels of immediate containers. 381.116 Section 381.116 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... the container: Provided, however, That there is, immediately to the right or left of such principal...

  10. 9 CFR 381.116 - Wording on labels of immediate containers.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Wording on labels of immediate containers. 381.116 Section 381.116 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... the container: Provided, however, That there is, immediately to the right or left of such principal...

  11. 9 CFR 381.116 - Wording on labels of immediate containers.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Wording on labels of immediate containers. 381.116 Section 381.116 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... the container: Provided, however, That there is, immediately to the right or left of such principal...

  12. An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia

    ClinicalTrials.gov

    2016-08-01

    Lipid Metabolism, Inborn Errors; Hypercholesterolemia, Autosomal Dominant; Hyperlipidemias; Metabolic Diseases; Hyperlipoproteinemia Type II; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Metabolic Disorder; Congenital Abnormalities; Hypercholesterolemia; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders

  13. Benchmarking Global Food Safety Performances: The Era of Risk Intelligence.

    PubMed

    Valleé, Jean-Charles Le; Charlebois, Sylvain

    2015-10-01

    Food safety data segmentation and limitations hamper the world's ability to select, build up, monitor, and evaluate food safety performance. Currently, there is no metric that captures the entire food safety system, and performance data are not collected strategically on a global scale. Therefore, food safety benchmarking is essential not only to help monitor ongoing performance but also to inform continued food safety system design, adoption, and implementation toward more efficient and effective food safety preparedness, responsiveness, and accountability. This comparative study identifies and evaluates common elements among global food safety systems. It provides an overall world ranking of food safety performance for 17 Organisation for Economic Co-Operation and Development (OECD) countries, illustrated by 10 indicators organized across three food safety risk governance domains: risk assessment (chemical risks, microbial risks, and national reporting on food consumption), risk management (national food safety capacities, food recalls, food traceability, and radionuclides standards), and risk communication (allergenic risks, labeling, and public trust). Results show all countries have very high food safety standards, but Canada and Ireland, followed by France, earned excellent grades relative to their peers. However, any subsequent global ranking study should consider the development of survey instruments to gather adequate and comparable national evidence on food safety.

  14. 16 CFR 1404.4 - Requirements to provide performance and technical data by labeling-Notice to purchasers.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... fixtures. Do not place insulation over such fixtures so as to entrap heat. Also keep this insulation away... SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS CELLULOSE INSULATION § 1404.4 Requirements to... insulation shall give notification of performance and technical data related to performance and safety (1) to...

  15. 16 CFR 1404.4 - Requirements to provide performance and technical data by labeling-Notice to purchasers.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... fixtures. Do not place insulation over such fixtures so as to entrap heat. Also keep this insulation away... SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS CELLULOSE INSULATION § 1404.4 Requirements to... insulation shall give notification of performance and technical data related to performance and safety (1) to...

  16. 16 CFR 1404.4 - Requirements to provide performance and technical data by labeling-Notice to purchasers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... fixtures. Do not place insulation over such fixtures so as to entrap heat. Also keep this insulation away... SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS CELLULOSE INSULATION § 1404.4 Requirements to... insulation shall give notification of performance and technical data related to performance and safety (1) to...

  17. 16 CFR 1404.4 - Requirements to provide performance and technical data by labeling-Notice to purchasers.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... fixtures. Do not place insulation over such fixtures so as to entrap heat. Also keep this insulation away... SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS CELLULOSE INSULATION § 1404.4 Requirements to... insulation shall give notification of performance and technical data related to performance and safety (1) to...

  18. [A case-control study on the risk factors of work-related acute pesticide poisoning among farmers from Jiangsu province].

    PubMed

    Tu, Zhi-bin; Cui, Meng-jing; Yao, Hong-yan; Hu, Guo-qing; Xiang, Hui-yun; Stallones, Lorann; Zhang, Xu-jun

    2012-04-01

    To explore the risk factors on cases regarding work-related acute pesticide poisoning among farmers of Jiangsu province. A population-based, 1:2 matched case-control study was carried out, with 121 patients as case-group paired by 242 persons with same gender, district and age less then difference of 3 years, as controls. Cases were the ones who had suffered from work-related acute pesticide poisoning. A unified questionnaire was used. Data base was established by EpiData 3.1, and SPSS 16.0 was used for both data single factor and multi-conditional logistics regression analysis. Results from the single factor logistic regression analysis showed that the related risk factors were: lack of safety guidance, lack of readable labels before praying pesticides, no regression during application, using hand to wipe sweat, using leaking knapsack, body contaminated during application and continuing to work when feeling ill after the contact of pesticides. Results from multi-conditional logistic regression analysis indicated that the lack of safety guidance (OR=2.25, 95%CI: 1.35-3.74), no readable labels before praying pesticides (OR=1.95, 95%CI: 1.19-3.18), wiping the sweat by hand during application (OR=1.97, 95%CI: 1.20-3.24) and using leaking knapsack during application (OR=1.82, 95%CI:1.10-3.01) were risk factors for the occurrence of work-related acute pesticide poisoning. The lack of safety guidance, no readable labels before praying pesticides, wiping the sweat by hand or using leaking knapsack during application were correlated to the occurrence of work-related acute pesticide poisoning.

  19. International Implications of Labeling Foods Containing Engineered Nanomaterials.

    PubMed

    Grieger, Khara D; Hansen, Steffen Foss; Mortensen, Ninell P; Cates, Sheryl; Kowalcyk, Barbara

    2016-05-01

    To provide greater transparency and comprehensive information to consumers regarding their purchase choices, the European Parliament and the Council have mandated via Regulation 1169/2011 that foods containing engineered nanomaterials (ENMs) be labeled. This review covers the main concerns related to the use of ENMs in foods and the potential impacts that this type of food labeling might have on diverse stakeholder groups, including those outside the European Union (EU), e.g., in the United States. We also provide recommendations to stakeholders for overcoming existing challenges related to labeling foods containing ENMs. The revised EU food labeling requirements will likely result in a number of positive developments and a number of challenges for stakeholders in both EU and non-EU countries. Although labeling of foods containing ENMs will likely improve transparency, provide more information to facilitate consumer decisions, and build trust among food safety authorities and consumers, critical obstacles to the successful implementation of these labeling requirements remain, including the need for (i) harmonized information requirements or regulations between countries in different regions of the world, (ii) clarification of the regulatory definitions of the ENMs to be used for food labeling, (iii) robust techniques to detect, measure, and characterize diverse ENMs in food matrices, and (iv) clarification of the list of ENMs that may be exempt from labeling requirements, such as several food additives used for decades. We recommend that food industries and food safety authorities be more proactive in communicating with the public and consumer groups regarding the potential benefits and risks of using ENMs in foods. Efforts should be made to improve harmonization of information requirements between countries to avoid potential international trade barriers.

  20. A phase 2, open-label, multicenter study of the long-term safety of siltuximab (an anti-interleukin-6 monoclonal antibody) in patients with multicentric Castleman disease.

    PubMed

    van Rhee, Frits; Casper, Corey; Voorhees, Peter M; Fayad, Luis E; van de Velde, Helgi; Vermeulen, Jessica; Qin, Xiang; Qi, Ming; Tromp, Brenda; Kurzrock, Razelle

    2015-10-06

    Multicentric Castleman disease (MCD) is a rare, systemic lymphoproliferative disorder driven by interleukin (IL)-6 overproduction. Siltuximab, an anti-IL-6 monoclonal antibody, has demonstrated durable tumor and symptomatic responses in a multinational, randomized, placebo-controlled study of MCD. This preplanned safety analysis was conducted to evaluate the long-term safety of siltuximab treatment among 19 patients with MCD who had stable disease or better and were enrolled in a phase-1 study and subsequent ongoing, open-label, phase-2 extension study. Dosing was 11 mg/kg administered intravenously every 3 weeks, per protocol, or every 6 weeks at the investigator's discretion. Safety monitoring focused on potential risks associated with the anti-IL-6 mechanism of action. Investigator-assessed disease control status was also documented. Median treatment duration for the 19 patients was 5.1 (range 3.4, 7.2) years, with 14 (74%) patients treated for >4 years. Grade-≥ 3 adverse events (AEs) reported in >1 patient included hypertension (n = 3) and nausea, cellulitis, and fatigue (n = 2 each). Grade-≥ 3 AEs at least possibly attributed to siltuximab were leukopenia, lymphopenia, and a serious AE of polycythemia (n = 1 each). Hypertriglyceridemia and hypercholesterolemia (total cholesterol) were reported in 8 and 9 patients, respectively. No disease relapses were observed, and 8 of 19 patients were able to switch to an every-6-week dosing schedule. All MCD patients in this extension study have received siltuximab for a prolonged duration (up to 7 years) without evidence of cumulative toxicity or treatment discontinuations and with few serious infections. All patients are alive, demonstrate sustained disease control, and continue to receive siltuximab.

  1. Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study.

    PubMed

    Silberstein, Stephen D; Calhoun, Anne H; Lipton, Richard B; Grosberg, Brian M; Cady, Roger K; Dorlas, Stefanie; Simmons, Kristy A; Mullin, Chris; Liebler, Eric J; Goadsby, Peter J; Saper, Joel R

    2016-08-02

    To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks. In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use. Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n = 30) and sham treatment (n = 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ = 1.2; p = 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95% confidence interval -11.9 to -3.8; p < 0.01). Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed. NCT01667250. This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS. © 2016 American Academy of Neurology.

  2. Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.

    PubMed

    Schuck, Robert N; Grillo, Joseph A

    2016-05-01

    Precision medicine promises to improve both the efficacy and safety of therapeutic products by better informing why some patients respond well to a drug, and some experience adverse reactions, while others do not. Pharmacogenomics is a key component of precision medicine and can be utilized to select optimal doses for patients, more precisely identify individuals who will respond to a treatment and avoid serious drug-related toxicities. Since pharmacogenomic biomarker information can help inform drug dosing, efficacy, and safety, pharmacogenomic data are critically reviewed by FDA staff to ensure effective use of pharmacogenomic strategies in drug development and appropriate incorporation into product labels. Pharmacogenomic information may be provided in drug or biological product labeling to inform health care providers about the impact of genotype on response to a drug through description of relevant genomic markers, functional effects of genomic variants, dosing recommendations based on genotype, and other applicable genomic information. The format and content of labeling for biologic drugs will generally follow that of small molecule drugs; however, there are notable differences in pharmacogenomic information that might be considered useful for biologic drugs in comparison to small molecule drugs. Furthermore, the rapid entry of biologic drugs for treatment of rare genetic diseases and molecularly defined subsets of common diseases will likely lead to increased use of pharmacogenomic information in biologic drug labels in the near future. In this review, we outline the general principles of therapeutic product labeling and discuss the utilization of pharmacogenomic information in biologic drug labels.

  3. The Long-Term Safety of S-Flurbiprofen Plaster for Osteoarthritis Patients: An Open-Label, 52-Week Study.

    PubMed

    Yataba, Ikuko; Otsuka, Noboru; Matsushita, Isao; Matsumoto, Hideo; Hoshino, Yuichi

    2016-08-01

    The newly developed S-flurbiprofen plaster (SFPP) is a tape-type patch that shows innovative percutaneous absorption. This study was designed to evaluate the safety of a long-term 52-week SFPP application to osteoarthritis (OA) patients. This was a multi-center, open-label, uncontrolled prospective study that included 201 OA patients. SFPP at 40 mg/day was applied to the site of pain in 101 patients and at 80 mg/day (2 patches) in 100 patients at a total of 301 sites for 52 weeks. The affected sites assessed included the knee (192), lumbar spine (66), cervical spine (26), and others (17). Drug safety was evaluated by medical examination, laboratory tests, and examination of vital signs. Efficacy was evaluated by the patient's and clinician's global assessments and clinical symptoms. Most patients (80.1 %) completed the 52-week SFPP application. The majority of drug-related adverse events (AEs) included mild dermatitis at the application sites and occurred in 46.8 % of the sites. No photosensitive dermatitis was observed. Systemic AEs occurred in 9.0 % of the patients; a serious AE (gastric ulcer hemorrhage) occurred in one patient. No clinically significant changes in the laboratory tests and vital signs were observed. The efficacy evaluation showed an improvement from 2 weeks after the SFPP application, which continued during the 52 weeks' treatment. No apparent safety concerns were observed, even during the long-term SFPP application. Therefore, SFPP could be an additional pharmacotherapy in OA treatment.

  4. A 24-Week, Open-Label Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of 13.3 mg/24 h Rivastigmine Patch in Patients With Severe Alzheimer Disease.

    PubMed

    Farlow, Martin R; Grossberg, George T; Sadowsky, Carl H; Meng, Xiangyi; Velting, Drew M

    2015-01-01

    The long-term safety, tolerability, and efficacy of high-dose 13.3 mg/24 h rivastigmine patch in severe Alzheimer disease was evaluated in a 24-week, open-label extension to the double-blind ACTION study. Safety and tolerability, and efficacy on the Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-Severe Impairment Version (ADCS-ADL-SIV), Severe Impairment Battery (SIB), and ADCS-Clinical Global Impression of Change (ADCS-CGIC) were assessed. Overall, 197 patients continued on 13.3 mg/24 h patch; 199 uptitrated from 4.6 mg/24 h to 13.3 mg/24 h patch. The incidence of adverse events (AEs), serious AEs and discontinuations due to AEs was similar in patients who continued on, and patients who uptitrated to, 13.3 mg/24 h patch (AEs: 57.9% and 59.8%; serious AEs: 16.2% and 16.1%; discontinuations: 11.2% and 12.1%, respectively). Larger mean changes from double-blind baseline were observed in patients uptitrated on the ADCS-ADL-SIV (-4.6; SD=8.7) and SIB (-7.0; SD=16.6), than those who continued on 13.3 mg/24 h patch (-3.9; SD=8.0 and -4.7; SD=16.8, respectively). ADCS-CGIC scores were comparable. There were no clinically relevant between-group differences in safety and tolerability. Greater decline was observed in patients with delayed uptitration to high-dose 13.3 mg/24 h patch than patients who continued on high-dose patch.

  5. An Open-Label Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (RECAP).

    PubMed

    Costabel, Ulrich; Albera, Carlo; Lancaster, Lisa H; Lin, Chin-Yu; Hormel, Philip; Hulter, Henry N; Noble, Paul W

    2017-01-01

    RECAP (NCT00662038) was an open-label extension study in patients with idiopathic pulmonary fibrosis (IPF) who completed either the Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis (ASCEND) 016 phase 3 trial or the Clinical Studies Assessing Pirfenidone in Idiopathic Pulmonary Fibrosis: Research of Efficacy and Safety Outcomes (CAPACITY) 004/006 phase 3 trials. To obtain long-term safety data for pirfenidone in patients with IPF in RECAP. Of the 1,334 patients who participated in the phase 3 trials, 1,058 entered RECAP. The final analysis from enrollment (September 2008) to June 2015 is presented. Mean (SD) and median (range) pirfenidone exposures in RECAP were 122 (98) weeks and 88 (>0 to 349) weeks, respectively, with a mean daily dose of 2,091.1 mg. Cumulative total exposure was 2,482 patient exposure years (PEY). The treatment-emergent adverse event (TEAE) rate was 701.9 per 100 PEY. The serious TEAE rate was 53.5 per 100 PEY, with the most common serious TEAE being IPF (11.1 per 100 PEY). Of the 231 deaths (9.3 per 100 PEY), the most common cause was IPF (5.4 per 100 PEY). The treatment discontinuation rate due to a TEAE was 17.9 per 100 PEY; discontinuations were due to IPF (7.2 per 100 PEY), pneumonia, respiratory failure, acute respiratory failure, rash (0.5 per 100 PEY each), and nausea (0.4 per 100 PEY). For patients from CAPACITY 004/006 who entered RECAP, the mean change in percent predicted forced vital capacity from RECAP baseline at 180 weeks was -9.6%. Median on-treatment survival from the first pirfenidone dose in RECAP was 77.2 months. RECAP provides long-term follow-up and safety data for pirfenidone that were consistent with the known profile, with no new safety signals observed. © 2017 The Author(s) Published by S. Karger AG, Basel.

  6. Endocytotic potential governs magnetic particle loading in dividing neural cells: studying modes of particle inheritance

    PubMed Central

    Tickle, Jacqueline A; Jenkins, Stuart I; Polyak, Boris; Pickard, Mark R; Chari, Divya M

    2016-01-01

    Aim: To achieve high and sustained magnetic particle loading in a proliferative and endocytotically active neural transplant population (astrocytes) through tailored magnetite content in polymeric iron oxide particles. Materials & methods: MPs of varying magnetite content were applied to primary-derived rat cortical astrocytes ± static/oscillating magnetic fields to assess labeling efficiency and safety. Results: Higher magnetite content particles display high but safe accumulation in astrocytes, with longer-term label retention versus lower/no magnetite content particles. Magnetic fields enhanced loading extent. Dynamic live cell imaging of dividing labeled astrocytes demonstrated that particle distribution into daughter cells is predominantly ‘asymmetric’. Conclusion: These findings could inform protocols to achieve efficient MP loading into neural transplant cells, with significant implications for post-transplantation tracking/localization. PMID:26785794

  7. A phase III, open-label, multicenter study to evaluate the safety and efficacy of long-term triple combination therapy with azilsartan, amlodipine, and hydrochlorothiazide in patients with essential hypertension.

    PubMed

    Rakugi, Hiromi; Shimizu, Kohei; Nishiyama, Yuya; Sano, Yuhei; Umeda, Yuusuke

    2018-06-01

    Patients with essential hypertension who are receiving treatment with an angiotensin II receptor blocker and a calcium channel blocker often develop inadequate blood pressure (BP) control and require the addition of a diuretic. This study aimed to evaluate the long-term safety and efficacy of a triple combination therapy with 20 mg azilsartan (AZL), 5 mg amlodipine (AML) and 12.5 mg hydrochlorothiazide (HCTZ). The phase III, open-label, multicenter study (NCT02277691) comprised a 4-week run-in period and 52-week treatment period. Patients with inadequate BP control despite AZL/AML therapy (n = 341) received 4 weeks' treatment with AZL/AML (combination tablet) + HCTZ (tablet) and 4 weeks' treatment with AZL/AML/HCTZ (combination tablet) in a crossover manner, followed by AZL/AML/HCTZ (combination tablet) from Week 8 of the treatment period up to Week 52. The primary and secondary endpoints were long-term safety and BP (office and home), respectively. Most adverse events (AEs) were mild or moderate in intensity, and no deaths or treatment-related serious AEs were reported. The triple therapy provided consistent BP-lowering effects in both office and home measurements. The triple combination therapy with AZL/AML/HCTZ was well tolerated and effective for 52 weeks in Japanese patients with essential hypertension.

  8. Efficacy and safety of once-daily, extended-release hydrocodone in individuals previously receiving hydrocodone/acetaminophen combination therapy for chronic pain.

    PubMed

    Bartoli, Adrian; Michna, Edward; He, Ellie; Wen, Warren

    2015-01-01

    Hydrocodone/acetaminophen combination analgesics are frequently prescribed for chronic pain management; however, acetaminophen presents potential hepatotoxicity to patients and thus dose limitations. These opioid medications are also widely abused. Once-daily, single-entity hydrocodone (Hysingla™ ER tablets [HYD]) is a novel formulation with abuse-deterrent properties for the management of chronic pain and represents a suitable option for those patients receiving analgesics containing the same opioid analgesic, hydrocodone. This post-hoc analysis evaluated the efficacy and safety of HYD in patients whose primary pre-study analgesic was hydrocodone/acetaminophen analgesics (23-31% of the study populations). Data were analyzed from two Phase III trials, a 12-week randomized, placebo-controlled trial (RCT) and an open-label, 52-week trial. In both trials, a dose-titration period with HYD was followed by respective periods of fixed-dose double-blind (randomized controlled trial [RCT]) or open-label, flexible-dose maintenance treatment. Pain intensity was assessed using a numerical rating scale (0-10, 0 = no pain). For the RCT, primary and sensitivity analyses of pain scores used different approaches to handle missing data. Safety data for both studies were summarized. In the RCT, the mean baseline pain score was 7.3. Pain relief was greater with HYD than placebo during double-blind treatment. In the open-label, flexible-dose trial, the majority of patients were maintained on their titrated dose. Mean baseline pain score was 6.3, about 57% of patients completed the 1-year maintenance period, and mean pain scores were between 3.6 and 4.1 during the maintenance period. Use of supplemental pain medication decreased or was maintained during the maintenance treatment with HYD. Adverse events in both trials were typical of those associated with opioid analgesics. In patients whose primary pretrial analgesic was hydrocodone/acetaminophen combination tablets, single-entity HYD was effective in reducing pain intensity and in maintaining analgesia over time without need for continued dose increase. HYD's safety and tolerability profiles were similar to other opioid analgesics.

  9. Electronic nicotine delivery systems: is there a need for regulation?

    PubMed

    Trtchounian, Anna; Talbot, Prue

    2011-01-01

    Electronic nicotine delivery systems (ENDS) purport to deliver nicotine to the lungs of smokers. Five brands of ENDS were evaluated for design features, accuracy and clarity of labelling and quality of instruction manuals and associated print material supplied with products or on manufacturers' websites. ENDS were purchased from online vendors and analysed for various parameters. While the basic design of ENDS was similar across brands, specific design features varied significantly. Fluid contained in cartridge reservoirs readily leaked out of most brands, and it was difficult to assemble or disassemble ENDS without touching nicotine-containing fluid. Two brands had designs that helped lessen this problem. Labelling of cartridges was very poor; labelling of some cartridge wrappers was better than labelling of cartridges. In general, packs of replacement cartridges were better labelled than the wrappers or cartridges, but most packs lacked cartridge content and warning information, and sometimes packs had confusing information. Used cartridges contained fluid, and disposal of nicotine-containing cartridges was not adequately addressed on websites or in manuals. Orders were sometimes filled incorrectly, and safety features did not always function properly. Print and internet material often contained information or made claims for which there is currently no scientific support. Design flaws, lack of adequate labelling and concerns about quality control and health issues indicate that regulators should consider removing ENDS from the market until their safety can be adequately evaluated.

  10. Blood specimen labelling errors: Implications for nephrology nursing practice.

    PubMed

    Duteau, Jennifer

    2014-01-01

    Patient safety is the foundation of high-quality health care, as recognized both nationally and worldwide. Patient blood specimen identification is critical in ensuring the delivery of safe and appropriate care. The practice of nephrology nursing involves frequent patient blood specimen withdrawals to treat and monitor kidney disease. A critical review of the literature reveals that incorrect patient identification is one of the major causes of blood specimen labelling errors. Misidentified samples create a serious risk to patient safety leading to multiple specimen withdrawals, delay in diagnosis, misdiagnosis, incorrect treatment, transfusion reactions, increased length of stay and other negative patient outcomes. Barcode technology has been identified as a preferred method for positive patient identification leading to a definitive decrease in blood specimen labelling errors by as much as 83% (Askeland, et al., 2008). The use of a root cause analysis followed by an action plan is one approach to decreasing the occurrence of blood specimen labelling errors. This article will present a review of the evidence-based literature surrounding blood specimen labelling errors, followed by author recommendations for completing a root cause analysis and action plan. A failure modes and effects analysis (FMEA) will be presented as one method to determine root cause, followed by the Ottawa Model of Research Use (OMRU) as a framework for implementation of strategies to reduce blood specimen labelling errors.

  11. Off-label use of medicines: The need for good practice guidelines.

    PubMed

    Dooms, Marc; Killick, James

    2017-01-01

    'Off-label use' is the term used for the prescription and dispensing of a medicinal product for any indication, patient group, route of administration, dosage or treatment regimen other than that listed in the Summary of Product Characteristics. In this article the authors present a brief overview of current practices of off-label use in Europe and the applicable European law and jurisprudence. They then go on to present a set of guidelines for best practice in off-label use which underlines the need for guidance on prescription to be firmly rooted in the need to ensure patient safety above all other concerns. The article was written from desk research and expert engagement, including a presentation and Q&A in the European Parliament. This article intends to demonstrate that off-label use entails increased risks for patients, especially when it is not underpinned by rigorous clinical studies or the reporting routes for use are not well defined. Europe is seeing a growing trend the promotion of off-label prescription of medicinal products for reasons other than pure medical need, including motives such as cost-containment. This poses a numer of questions for the ethical and legal framework for medicine prescription and dispensing in Europe.

  12. 16 CFR 1209.31 - Purpose and applicability.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 1209.31 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS..., importers, and private labelers must follow to certify that their products comply with the Amended Interim... temporary household or residence, a school, in recreation or otherwise. The standard applies to cellulose...

  13. 16 CFR 1209.31 - Purpose and applicability.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 1209.31 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS..., importers, and private labelers must follow to certify that their products comply with the Amended Interim... temporary household or residence, a school, in recreation or otherwise. The standard applies to cellulose...

  14. 16 CFR 1209.31 - Purpose and applicability.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 1209.31 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS..., importers, and private labelers must follow to certify that their products comply with the Amended Interim... temporary household or residence, a school, in recreation or otherwise. The standard applies to cellulose...

  15. Fact Sheet: Revisions to the Occupational Safety and Health Administration Hazard Communication Standards (HCS)

    EPA Pesticide Factsheets

    On March 26, 2012, Occupational Safety and Health Administration (OSHA) modified its HCS to conform to the United Nations’ (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS), to improve consistency and quality of information.

  16. Safety issues with herbal products.

    PubMed

    Marrone, C M

    1999-12-01

    To review safety issues associated with the use of herbal products. Literature accessed through MEDLINE and other Internet search engines. Key search terms included herbs, dietary supplements, and safety. A misconception exists among consumers that herbal remedies are safe because they are natural. In an effort to provide healthcare practitioners with information necessary for a patient discussion, a review of safety concerns with herbal products was conducted. Several safety concerns exist with herbal products including lack of safety data, absence of quality-control requirements for potency and purity, and lenient labeling standards.

  17. Social responsibility and work conditions: building a reference label, Démarche T®.

    PubMed

    Biquand, Sylvain; Zittel, Benoit

    2012-01-01

    Corporate Social Responsibility (CSR) is now considered in large and global companies and the recent publication of the ISO 26000 standard clarifies the targets. Based on our consultancy's experience for fifteen years in ergonomics mainly in French small and medium enterprises, we developed a label to coax and value efforts of companies in dealing with health and safety at the work place as required by ISO 26000 paragraph 6.4. The formal approach of ISO describes what should be achieved but gives no cue on how actual conditions of work should be improved. The label, called Démarche T (ie Process W where W stands for work) aims the management of work conditions as a process, giving visibility and credit to companies for their continuous involvement in the matter. We describe the items and processes that are part of our assessment. We first conduct an ergonomic diagnosis including the analysis of records on health, physical and psychological well-being, observations at the workplace and interviews with the workers. This diagnosis is followed by recommendations. The fulfillment of these is assessed yearly. Items under assessment include: - ergonomics, health and safety in the companies statements and their impact in actual project management; - relations with workers through the committee for health and safety; - actual results on health, safety and work conditions. On a local level, we give the companies passing the label a competitive edge in recruiting better candidates motivated by good work conditions, and help them fulfill ISO 26000 requirements, an increasingly decisive advantage to benefit from public regional and European support. Our paper describes the diagnosis and follow-up process.

  18. Safety and Efficacy of Rivastigmine in Adolescents with Down Syndrome: Long-Term Follow-Up

    PubMed Central

    Spiridigliozzi, Gail A.; Crissman, Blythe G.; McKillop, Jane Anne; Yamamoto, Haru; Kishnani, Priya S.

    2010-01-01

    Abstract Following the completion of a 20-week, open-label study of the safety and efficacy of liquid rivastigmine for adolescents with Down syndrome, 5 of the 10 adolescents in the clinical trial continued long-term rivastigmine therapy and 5 did not. After an average period of 38 months, all 10 subjects returned for a follow-up assessment to determine the safety and efficacy of long-term rivastigmine use. Rivastigmine was well tolerated and overall health appeared to be unaffected by long-term rivastigmine use. Performance change on cognitive and language measures administered at the termination of the open-label clinical trial was compared between the two groups. No between-group difference in median performance change across the long-term period was found, suggesting that the long-term use of rivastigmine does not improve cognitive and language performance. However, two subjects demonstrated remarkable improvement in adaptive function over the long-term period. Both subjects had received long-term rivastigmine therapy. The discussion addresses the challenge of assessing cognitive change in clinical trials using adolescents with Down syndrome as subjects and the use of group versus individual data to evaluate the relevance of medication effects. PMID:21186971

  19. Pesticide Safety for Non-Certified Mixers, Loaders and Applicators = Uso Seguro de Pesticidas para Mezcladores, Cargadores y Aplicadores no Certificados.

    ERIC Educational Resources Information Center

    Poli, Bonnie; Fluker, Sam S.

    Written in English and Spanish and completely illustrated, this manual provides basic safety information for pesticide workers. Mixers, loaders, and applicators work with pesticides at their greatest strength and have the highest risk of poisoning. Understanding the pesticide label is the first step to pesticide safety. The words…

  20. 16 CFR 1500.20 - Labeling requirement for advertising toys and games.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... and games. 1500.20 Section 1500.20 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.20 Labeling requirement for advertising toys and games. (a) Scope. This section applies to..., that is used in various children's games, generally as a playing piece or marker. The term “marble...

  1. 16 CFR 1500.20 - Labeling requirement for advertising toys and games.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... and games. 1500.20 Section 1500.20 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.20 Labeling requirement for advertising toys and games. (a) Scope. This section applies to..., that is used in various children's games, generally as a playing piece or marker. The term “marble...

  2. 16 CFR 1500.20 - Labeling requirement for advertising toys and games.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... and games. 1500.20 Section 1500.20 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.20 Labeling requirement for advertising toys and games. (a) Scope. This section applies to..., that is used in various children's games, generally as a playing piece or marker. The term “marble...

  3. 16 CFR 1500.20 - Labeling requirement for advertising toys and games.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... and games. 1500.20 Section 1500.20 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.20 Labeling requirement for advertising toys and games. (a) Scope. This section applies to..., that is used in various children's games, generally as a playing piece or marker. The term “marble...

  4. 9 CFR 590.955 - Labeling of shipping containers of eggs or egg products for importation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... eggs or egg products for importation. 590.955 Section 590.955 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Imports § 590.955 Labeling of shipping containers of eggs or egg...

  5. 30 CFR 47.73 - Providing labels and MSDSs to customers.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Providing labels and MSDSs to customers. 47.73 Section 47.73 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND... MSDSs to customers. For a hazardous chemical produced at the mine, the operator must provide customers...

  6. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25477618

  7. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24421565

  8. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:27621511

  9. 75 FR 57794 - Notice of Public Information Collection(s) Being Submitted for Review and Approval to the Office...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-22

    ..., antennas placed on subscriber premises, and the state of the market. The demarcation point burden consists... must ensure that subscriber antennas are labeled to give notice of potential radio frequency safety hazards of these antennas. Labeling information (third party disclosure requirement) should include...

  10. 76 FR 78929 - Establishing Timeframes for Implementation of Product Safety Labeling Changes; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... labeling; (2) supply chain issues; and, (3) other issues. FDA may use the information received to develop...? B. Supply Chain Issues 3. What are the supply chain factors (including storage, shipping, and... the optimal point in the supply chain (e.g., newly manufactured product, newly shipped product) and...

  11. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24958946

  12. 9 CFR 381.137 - Evidence of labeling and devices approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Evidence of labeling and devices approval. 381.137 Section 381.137 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION...

  13. 9 CFR 381.205 - Labeling of immediate containers of poultry products offered for entry.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of immediate containers of poultry products offered for entry. 381.205 Section 381.205 Animals and Animal Products FOOD SAFETY AND...

  14. 9 CFR 381.206 - Labeling of shipping containers of poultry products offered for entry.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of shipping containers of poultry products offered for entry. 381.206 Section 381.206 Animals and Animal Products FOOD SAFETY AND...

  15. 9 CFR 590.955 - Labeling of shipping containers of eggs or egg products for importation.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... eggs or egg products for importation. 590.955 Section 590.955 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Imports § 590.955 Labeling of shipping containers of eggs or egg...

  16. 9 CFR 355.35 - Label information to be displayed on principal panel.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Label information to be displayed on principal panel. 355.35 Section 355.35 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... AND VOLUNTARY INSPECTION AND CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA...

  17. 9 CFR 355.35 - Label information to be displayed on principal panel.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Label information to be displayed on principal panel. 355.35 Section 355.35 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... AND VOLUNTARY INSPECTION AND CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA...

  18. Recommended energy and nutrients intakes in the European Union: 2008-2016

    PubMed

    García Gabarra, Antoni; Castellà Soley, Marta; Calleja Fernández, Alicia

    2017-03-30

    The aim of this document is to refl ect the changes happened in the European Union legislation and the opinions of the European Food Safety Authority in relation to the nutritional labeling on food, the reference values for energy, macronutrients and micronutrients, and the tolerable upper safe levels. The European legislation in force uses the labeling reference values established by the Scientific Committee on Food in 2003. There would be advisable an update of them from the reference values for vitamins and minerals established by the European Food Safety Authority. Equally, there would be good to include reference labeling values for polyunsaturated fatty acids, dietary fiber and choline, and specific reference labeling values for children from 6 to 36 months. For vitamins and minerals there would be desirable the revision of tolerable upper safe levels and the establishment of maximum amounts allowed in fortified food and food supplements in the European Union; its absence might represent a risk in some population groups for an excessive and unsafe intake of certain minerals and vitamins.

  19. Immunogenicity and safety of purified chick-embryo cell rabies vaccine under Zagreb 2-1-1 or 5-dose Essen regimen in Chinese children 6 to 17 years old and adults over 50 years: A randomized open-label study

    PubMed Central

    Li, RongCheng; Li, YanPing; Wen, ShuQing; Wen, HuiChun; Nong, Yi; Mo, Zhaojun; Xie, Fang; Pellegrini, Michele

    2015-01-01

    The aim of this Phase IIIb, open-label, randomized study was to demonstrate the non-inferiority of immune responses and to assess the safety of a purified chick-embryo cell rabies vaccine (PCECV) in healthy Chinese children (6 to 17 years) and older adults (≥51 years) following 2 alternative intramuscular (IM) simulated post-exposure prophylaxis (PEP) regimens: 4-dose Zagreb or 5-dose Essen regimen. Serum samples were collected prior to vaccination on Days 1 and 15 and on day 43 to assess immune response by rabies virus neutralizing antibody (RVNA) concentrations. Solicited adverse events (AEs) were recorded for up to 7 days following each vaccine dose, and unsolicited AEs throughout the entire study period. PCECV vaccination induced a strong immune response at Day 15, and the non-inferiority in immune response of the Zagreb vs. the Essen regimen was demonstrated in children and older adults. At Day 15,100% of children (N = 224), and 99% of subjects ≥51 years of age (N = 376) developed adequate RVNA concentrations (≥0.5 IU/mL); at Day 43 all subjects achieved RVNA concentrations ≥0.5 IU/mL, for both PEP regimens. The well-known tolerability and safety profile of the PCECV was again observed in this study following either Zagreb or Essen regimens. Rabies PEP vaccination with PCECV following a Zagreb regimen induced immune responses non-inferior to those of the Essen regimen, and had a similar safety and tolerability profile to the Essen regimen in Chinese children, adolescents, and adults over 51 years. ClinicalTrials.gov identifier: NCT01680016. PMID:25692350

  20. Immunogenicity and safety of purified chick-embryo cell rabies vaccine under Zagreb 2-1-1 or 5-dose Essen regimen in Chinese children 6 to 17 years old and adults over 50 years: a randomized open-label study.

    PubMed

    Li, RongCheng; Li, YanPing; Wen, ShuQing; Wen, HuiChun; Nong, Yi; Mo, Zhaojun; Xie, Fang; Pellegrini, Michele

    2015-01-01

    The aim of this Phase IIIb, open-label, randomized study was to demonstrate the non-inferiority of immune responses and to assess the safety of a purified chick-embryo cell rabies vaccine (PCECV) in healthy Chinese children (6 to 17 years) and older adults (≥51 years) following 2 alternative intramuscular (IM) simulated post-exposure prophylaxis (PEP) regimens: 4-dose Zagreb or 5-dose Essen regimen. Serum samples were collected prior to vaccination on Days 1 and 15 and on day 43 to assess immune response by rabies virus neutralizing antibody (RVNA) concentrations. Solicited adverse events (AEs) were recorded for up to 7 days following each vaccine dose, and unsolicited AEs throughout the entire study period. PCECV vaccination induced a strong immune response at Day 15, and the non-inferiority in immune response of the Zagreb vs. the Essen regimen was demonstrated in children and older adults. At Day 15,100% of children (N = 224), and 99% of subjects ≥51 years of age (N = 376) developed adequate RVNA concentrations (≥0.5 IU/mL); at Day 43 all subjects achieved RVNA concentrations ≥0.5 IU/mL, for both PEP regimens. The well-known tolerability and safety profile of the PCECV was again observed in this study following either Zagreb or Essen regimens. Rabies PEP vaccination with PCECV following a Zagreb regimen induced immune responses non-inferior to those of the Essen regimen, and had a similar safety and tolerability profile to the Essen regimen in Chinese children, adolescents, and adults over 51 years. ClinicalTrials.gov identifier: NCT01680016.

  1. Gluten-Free Diet Indications, Safety, Quality, Labels, and Challenges

    PubMed Central

    Rostami, Kamran; Bold, Justine; Parr, Alison; Johnson, Matt W.

    2017-01-01

    A gluten-free diet (GFD) is the safest treatment modality in patient with coeliac disease (CD) and other gluten-related disorders. Contamination and diet compliance are important factors behind persistent symptoms in patients with gluten related-disorders, in particular CD. How much gluten can be tolerated, how safe are the current gluten-free (GF) products, what are the benefits and side effects of GFD? Recent studies published in Nutrients on gluten-free products’ quality, availability, safety, as well as challenges related to a GFD are discussed. PMID:28786929

  2. Assessing the Role of Shape and Label in the Misleading Packaging of Food Imitating Products: From Empirical Evidence to Policy Recommendation

    PubMed Central

    Basso, Frédéric; Bouillé, Julien; Le Goff, Kévin; Robert-Demontrond, Philippe; Oullier, Olivier

    2016-01-01

    Food imitating products are chemical consumer items used frequently in the household for cleaning and personal hygiene (e.g., bleach, soap, and shampoo), which resemble food products. Their containers replicate elements of food package design such as possessing a shape close in style to drinking product containers or bearing labels that depict colorful fruits. In marketing, these incongruent forms are designed to increase the appeal of functional products, leading to chemical consumer product embellishment. However, due to the resulting visual ambiguity, food imitating products may expose consumers to the risk of being poisoned from ingestion. Thus, from a public health perspective, food imitating products are considered dangerous chemical products that should not be sold, and may merit being recalled for the safety of consumers. To help policymakers address the hazardous presence of food imitating products, the purpose of this article is to identify the specific design features that generate most ambiguity for the consumer, and therefore increase the likelihood of confusion with foodstuffs. Among the visual elements of food packaging, the two most important features (shape and label) are manipulated in a series of three lab studies combining six Implicit Association Tests (IATs) and two explicit measures on products' drinkability and safety. IATs were administered to assess consumers' implicit association of liquid products with tastiness in a within-subject design in which the participants (N = 122) were presented with two kinds of food imitating products with a drink shape or drink label compared with drinks (experiential products with congruent form) and classic chemical products (hygiene products) (functional products with congruent form). Results show that chemical consumer products with incongruent drink shapes (but not drink labels) as an element of food package design are both implicitly associated with tastiness and explicitly judged as safe and drinkable. These results require confirmation in other studies involving different shapes and labels. Notwithstanding, due to the misleading effect of this ambiguity, public health authorities are thus well advised to focus their market surveillance on chemical products emulating a food or drink shape. PMID:27065919

  3. Safe use of vaccines and vaccine compliance with food safety requirements.

    PubMed

    Grein, K; Papadopoulos, O; Tollis, M

    2007-08-01

    Advanced technologies and regulatory regimes have contributed to the availability of veterinary vaccines that have high quality and favourable safety profiles in terms of potential risks posed to the target animals, the persons who come into contact with the vaccine, the consumers of food derived from vaccinated animals and the environment. The authorisation process requires that a range of safety studies are provided to evaluate the products. The design and production of vaccines, and their safe use, are primarily assessed by using data gathered from extensive pre-marketing studies performed on target animals and specific quality tests. The current post-marketing safeguards include good manufacturing practices, batch safety testing, inspections and pharmacovigilance. In addition to hazard identification, a full benefit/risk evaluation needs to be undertaken. The outcome of that evaluation will determine options for risk management and affect regulatory decisions on the safety of the vaccine; options might, for example, include special warnings on package inserts and labels.

  4. The Influence of Sugar-Sweetened Beverage Warnings

    PubMed Central

    VanEpps, Eric M.; Roberto, Christina A.

    2017-01-01

    Introduction California, New York, and the cities of San Francisco and Baltimore have introduced bills requiring health-related warning labels for sugar-sweetened beverages. This study measures the extent to which these warning labels influence adolescents’ beliefs and hypothetical choices. Design Participants completed an online survey in which they chose a beverage in a hypothetical vending machine task, rated perceptions of different beverages, and indicated interest in coupons for beverages. Data were collected and analyzed in 2015. Setting/participants A total of 2,202 demographically diverse adolescents aged 12–18 years completed the online survey. Intervention Participants were randomly assigned to one of six conditions: (1) no warning label; (2) calorie label; (3–6) one of four text versions of a warning label (e.g., SAFETY WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay). Main outcome measures Hypothetical choices, perceptions of beverages, interest in coupons, and endorsement of warning label policies were assessed. Results Controlling for frequency of beverage purchases, significantly fewer adolescents chose a sugar-sweetened beverage in three of the four warning label conditions (65%, 63%, and 61%) than in the no label (77%) condition. Adolescents in the four warning label conditions chose fewer sugar-sweetened beverage coupons and believed that sugar-sweetened beverages were less likely to help them lead a healthy life and had more added sugar compared with the no label condition. Conclusions Health-related warning labels on sugar-sweetened beverages improved adolescents’ recognition of the sugar content of such beverages and reduced hypothetical choices to buy sugar-sweetened beverages. PMID:27617366

  5. Budesonide Foam Has a Favorable Safety Profile for Inducing Remission in Mild-to-Moderate Ulcerative Proctitis or Proctosigmoiditis.

    PubMed

    Rubin, David T; Sandborn, William J; Bosworth, Brian; Zakko, Salam; Gordon, Glenn L; Sale, Mark E; Rolleri, Robert L; Golden, Pamela L; Barrett, Andrew C; Bortey, Enoch; Forbes, William P

    2015-11-01

    Budesonide foam, a rectally administered, second-generation corticosteroid with extensive hepatic first-pass metabolism, is efficacious for the treatment of mild-to-moderate ulcerative proctitis and ulcerative proctosigmoiditis. The aim of this study was to comprehensively assess the safety and pharmacokinetic profile of budesonide foam. Data from five phase III studies were pooled to further evaluate safety, including an open-label study (once-daily treatment for 8 weeks), an active-comparator study (once-daily treatment for 4 weeks), and two placebo-controlled studies and an open-label extension study (twice-daily treatment for 2 weeks, then once daily for 4 weeks). Data from the placebo-controlled studies and two phase I studies (i.e., patients with mild-to-moderate ulcerative colitis and healthy volunteers) were pooled to evaluate the pharmacokinetics of budesonide foam. A similar percentage of patients reported adverse events in the budesonide foam and placebo groups, with the majority of adverse events being mild or moderate in intensity (93.3 vs 96.0%, respectively). Adverse events occurred in 41.4 and 36.3% of patients receiving budesonide foam and placebo, respectively. Mean morning cortisol concentrations remained within the normal range for up to 8 weeks of treatment; there were no clinically relevant effects of budesonide foam on the hypothalamic-pituitary-adrenal axis. Population pharmacokinetic analysis demonstrated low systemic exposure after budesonide foam administration. This integrated analysis demonstrated that budesonide foam for the induction of remission of distal ulcerative colitis is safe overall, with no clinically relevant effects on the hypothalamic-pituitary-adrenal axis.

  6. Revisions to labeling requirements for blood and blood components, including source plasma. Final rule.

    PubMed

    2012-01-03

    The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ``ABC Codabar'' system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling.

  7. Consumer trust in the Australian food system - The everyday erosive impact of food labelling.

    PubMed

    Tonkin, Emma; Webb, Trevor; Coveney, John; Meyer, Samantha B; Wilson, Annabelle M

    2016-08-01

    Consumer trust in food system actors is foundational for ensuring consumer confidence in food safety. As food labelling is a direct communication between consumers and food system actors, it may influence consumer perceptions of actor trustworthiness. This study explores the judgements formed about the trustworthiness of the food system and its actors through labelling, and the expectations these judgements are based on. In-depth, semi-structured interviews with 24 Australian consumers were conducted. Theoretical sampling focussed on shopping location, dietary requirements, rurality, gender, age and educational background. The methodological approach used (adaptive theory) enabled emerging data to be examined through the lens of a set of guiding theoretical concepts, and theory reconsidered in light of emerging data. Food labelling acted as a surrogate for personal interaction with industry and government for participants. Judgements about the trustworthiness of these actors and the broader food system were formed through interaction with food labelling and were based on expectations of both competence and goodwill. Interaction with labelling primarily reduced trust in actors within the food system, undermining trust in the system as a whole. Labelling has a role as an access point to the food system. Access points are points of vulnerability for systems, where trust can be developed, reinforced or broken down. For the participants in this study, in general labelling demonstrates food system actors lack goodwill and violate their fiduciary responsibility. This paper provides crucial insights for industry and policy actors to use this access point to build, rather than undermine, trust in food systems. Copyright © 2016 Elsevier Ltd. All rights reserved.

  8. Investigating factors influencing consumer willingness to buy GM food and nano-food

    NASA Astrophysics Data System (ADS)

    Yue, Chengyan; Zhao, Shuoli; Cummings, Christopher; Kuzma, Jennifer

    2015-07-01

    Emerging technologies applied to food products often evoke controversy about their safety and whether to label foods resulting from their use. As such, it is important to understand the factors that influence consumer desires for labeling and their willingness-to-buy (WTB) these food products. Using data from a national survey with US consumers, this study employs structural equation modeling to explore relationships between potential influences such as trust in government to manage technologies, views on restrictive government policies, perceptions about risks and benefits, and preferences for labeling on consumer's WTB genetically modified (GM) and nano-food products. Some interesting similarities and differences between GM- and nano-food emerged. For both technologies, trust in governing agencies to manage technologies did not influence labeling preferences, but it did influence attitudes about the food technologies themselves. Attitudes toward the two technologies, as measured by risk-benefit comparisons and comfort with consumption, also greatly influenced views of government restrictive policies, labeling preferences, and WTB GM or nano-food products. For differences, labeling preferences were found to influence WTB nano-foods, but not WTB GM foods. Gender and religiosity also had varying effects on WTB and labeling preferences: while gender and religiosity influenced labeling preferences and WTB for GM foods, they did not have a significant influence for nano-foods. We propose some reasons for these differences, such as greater media attention and other heuristics such as value-based concerns about "modifying life" with GM foods. The results of this study can help to inform policies and communication about the application of these new technologies in food products.

  9. 78 FR 77554 - Reports, Forms and Record Keeping Requirements; Agency Information Collection Activity Under OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-23

    ... information described is the ``Consolidated Child Restraint System Registration, Labeling and Defect...: National Highway Traffic Safety Administration Title: Consolidated Child Restraint System Registration... the Federal motor vehicle safety standard for child restraint systems (CRSs) to expand its...

  10. Training Requirements in OSHA Standards and Training Guidelines.

    ERIC Educational Resources Information Center

    Occupational Safety and Health Administration, Washington, DC.

    This booklet contains Occupational Safety and Health Administration (OSHA) training requirements, excerpted from OSHA standards. The booklet is designed to help employers, safety and health professionals, training directors, and others who need to know training requirements. (Requirements for posting information, warning signs, labels, and the…

  11. 49 CFR 567.1 - Purpose.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Federal Theft Prevention Standards (part 541 of this chapter), are applicable to the vehicle. ... and location of, and other requirements for, the certification label to be affixed to motor vehicles as required by the National Traffic and Motor Vehicle Safety Act, as amended (the Vehicle Safety Act...

  12. Melatonin for Sleep in Children with Autism: A Controlled Trial Examining Dose, Tolerability, and Outcomes

    ERIC Educational Resources Information Center

    Malow, Beth; Adkins, Karen W.; McGrew, Susan G.; Wang, Lily; Goldman, Suzanne E.; Fawkes, Diane; Burnette, Courtney

    2012-01-01

    Supplemental melatonin has shown promise in treating sleep onset insomnia in children with autism spectrum disorders (ASD). Twenty-four children, free of psychotropic medications, completed an open-label dose-escalation study to assess dose-response, tolerability, safety, feasibility of collecting actigraphy data, and ability of outcome measures…

  13. A multicenter, open-label trial to evaluate the quality of life in adults with ADHD treated with long-acting methylphenidate (OROS MPH): Concerta Quality of Life (CONQoL) study.

    PubMed

    Mattos, Paulo; Louzã, Mário Rodrigues; Palmini, André Luís Fernandes; de Oliveira, Irismar Reis; Rocha, Fábio Lopes

    2013-07-01

    The available literature provides few studies on the effectiveness of methylphenidate in improving quality of life in individuals with ADHD. To assess the effectiveness of methylphenidate OROS formulation (OROS MPH) through QoL in adults with ADHD. A 12-week, multicenter, open-label trial involving 60 patients was used. The measures used were Adult Self-Rating Scale, Adult ADHD Quality of Life Scale (AAQoL), State and Trait Anxiety Inventory (STAI), Hamilton Depression Rating Scale (HAM-D), Clinical Global Impression (CGI), and safety measures. A significance statistic level of 5% was adopted. Analyses included 60 patients (66.7% male; M age = 31.1 years) for safety and 58 patients for effectiveness. All AAQoL subscales improved from baseline to Week 12 (p < .0001), as well as the Total AAQoL (p < .0001). A significant reduction on Clinical Global Impression-Improvement (CGI-I), HAM-D, STAI, and ASRS scores was observed (p < .0001). No serious adverse event was reported. Treatment of adult ADHD patients with OROS MPH improves QoL.

  14. Peer-Reviewed Publication of Clinical Trials Completed for Pediatric Exclusivity

    PubMed Central

    Benjamin, Daniel Kelly; Smith, Philip Brian; Murphy, M. Dianne; Roberts, Rosemary; Mathis, Lisa; Avant, Debbie; Califf, Robert M; Li, Jennifer S.

    2009-01-01

    Context Much of pediatric drug use is “off-label” because appropriate pediatric studies have not been conducted and the drugs have not been labeled by the US Food and Drug Administration (FDA) for use in children. In 1997, Congress authorized FDA to grant extensions of marketing rights known as “pediatric exclusivity” if FDA-requested pediatric trials were conducted. As a result, there have been over 100 product labeling changes. The publication status of studies completed for pediatric exclusivity has not been evaluated. Objective To quantify the dissemination of results of studies conducted for pediatric exclusivity into the peer-review literature. Design Cohort study of all trials conducted for Pediatric Exclusivity, the subsequent labeling changes, and the publication of those studies in peer-reviewed journals. We categorized each study in the exclusivity application as ”successful” or “unsuccessful” based on FDA approval of the indication sought by the sponsor. We categorized any labeling changes resulting from the studies as ”positive” or “negative” for the drug under study. We then evaluated aspects of the studies and product label changes that were associated with subsequent publication in peer-reviewed medical journals. Main Outcome Measures Publication of the trial data in peer-reviewed journals. Results Between 1998 and 2004, 253 studies were submitted to FDA for pediatric exclusivity: 50% evaluated efficacy, 20% were multi-dose pharmacokinetic, 13% were single-dose pharmacokinetic, and 17% were safety studies. Labeling changes were positive for 127/253 (50%) of studies; only 112/253 (44%) were published. Efficacy studies and those with a favorable labeling change were more likely to be published. Of 100 studies resulting in important labeling changes, only 33 were published. Conclusions The pediatric exclusivity program has been successful in encouraging drug studies in children. However, the dissemination of these results in the peer-reviewed literature is limited. The results of these trials and future studies conducted for pediatric exclusivity should be published in peer-reviewed journals. Mechanisms to more widely disperse this information warrant further evaluation. PMID:16968851

  15. Food safety and food labeling from the viewpoint of the consumers.

    PubMed

    Watanabe, Shaw; Melby, Melissa; Aiba, Naomi

    2009-01-01

    Distrust of food safety has grown among the Japanese people after the occurrence of bovine spongiform encephalitis (BSE) in 2001. The Food Safety Commission was formed under the Cabinet Office and made a network among the ministries. The newly-established Consumer Agency may strengthen the quick response to emergencies. Shoku-iku (food and dietary education) Law is being implemented by the Cabinet Office with cooperation from relevant ministries and NGOs. Food Sanitation Law and Health Promotion Law are briefly explained, and the necessity of functional nutriology for non-nutrient biologically active substances is described. With regard to public health nutrition, a new food label showing energy balance and antioxidant unit (AOU) as a surrogate marker of fruit and vegetables has been developed for tailor-made nutrition which makes it easy to for individuals to control energy intake.

  16. To Take or Not to Take With Meals? Unraveling Issues Related to Food Effects Labeling for Oral Antineoplastic Drugs.

    PubMed

    Deng, Jiexin; Brar, Satjit S; Lesko, Lawrence J

    2017-12-02

    There has been controversy regarding whether bioavailability of certain oral oncology drugs should be maximized by taking these medications with food, irrespective of label instructions in the dosing and administration section. To provide insight into this controversy, we conducted an in-depth analysis for oral antineoplastic drugs approved by the Food and Drug Administration in 2000-2016 and identified important issues influencing food labeling decisions. Furthermore, a case study involving sonidegib, a drug approved for locally advanced basal cell carcinoma with a significant food effect on exposure, was used to demonstrate the consequences of failure to adhere to food label recommendations using drug-specific population pharmacokinetic and exposure-toxicity models. In 2000-2009, 80% (4 out of 5) of all approved oral antineoplastics with increased bioavailability in the fed state were labeled as "take on empty stomach." In contrast, we found that in 2010-2016 there is a greater diversity in food recommendations for drugs with increased bioavailability in the fed state. Currently, many oral oncology drugs are given with food to maximize their bioavailability; however, as seen from our case study of sonidegib, failure to fully adhere to label recommendations to either take with food or not could lead to adverse consequences in terms of safety and efficacy. © 2017, The American College of Clinical Pharmacology.

  17. A 6-Month Open-Label Extension Study of Vortioxetine in Pediatric Patients with Depressive or Anxiety Disorders

    PubMed Central

    Robb, Adelaide S.; DelBello, Melissa P.; Huss, Michael; McNamara, Nora K.; Sarkis, Elias H.; Scheffer, Russell E.; Poulsen, Lis H.; Chen, Grace; Lemming, Ole M.; Auby, Philippe

    2018-01-01

    Abstract Objectives: In this 6-month open-label extension (OLE) of NCT01491035 (a 14-day, open-label, pharmacokinetic/safety lead-in study), the long-term safety and tolerability of vortioxetine (5–20 mg/day) were investigated in children and adolescents with a DSM-IV-TR™ diagnosis of depressive or anxiety disorder in the United States or Germany. The study also was designed to provide data to inform dose selection and titration in future pediatric studies with vortioxetine. Methods: Safety evaluations included spontaneously reported adverse events (AEs), the Columbia Suicide Severity Rating Scale (C-SSRS), and the Pediatric Adverse Events Rating Scale (PAERS; clinician administered). Clinical effectiveness was determined by Clinical Global Impressions. Comorbid attention-deficit/hyperactivity disorder was permitted, including concomitant use of stimulant medication (US sites only). Results: Of the 47 patients who completed the lead-in period, 41 continued into the OLE. Most patients (n = 39 [95%]) continued their previous dose regimen. Twenty-one patients (51%) withdrew during the OLE; the most common primary reasons were administrative [n = 8], AEs [n = 4], and lack of efficacy [n = 3]. Thirty-five patients (85%) had ≥1 AE, 86% of which were mild or moderate in severity. Five patients (12%) reported a severe AE, none of which was considered related to study medication. The most common AEs (≥10%) were headache (27%), nausea (20%), dysmenorrhea (females; 19%), and vomiting (15%), with no relationship between AE intensity and age or dose. Five patients reported instances of suicidal ideation during the OLE, one of whom also reported this during the lead-in period. Two patients had nonsuicidal self-injurious behavior; one had a nonfatal suicide attempt. Throughout the study, there was a decrease over time in the incidence and intensity of AEs collected using the PAERS. Effectiveness assessment indicated a trend toward improvement based on numeric results. Conclusion: This OLE confirms the findings from the lead-in study, which concluded that a dosing strategy of 5–20 mg/day is safe, well tolerated, and suitable for future clinical studies of vortioxetine in pediatric patients. PMID:29035574

  18. Efficacy, Safety, and Dose of Pafuramidine, a New Oral Drug for Treatment of First Stage Sleeping Sickness, in a Phase 2a Clinical Study and Phase 2b Randomized Clinical Studies

    PubMed Central

    Burri, Christian; Yeramian, Patrick D.; Merolle, Ada; Serge, Kazadi Kyanza; Mpanya, Alain; Lutumba, Pascal; Mesu, Victor Kande Betu Ku; Lubaki, Jean-Pierre Fina; Mpoto, Alfred Mpoo; Thompson, Mark; Munungu, Blaise Fungula; Josenando, Théophilo; Bernhard, Sonja C.; Olson, Carol A.; Blum, Johannes; Tidwell, Richard R.; Pohlig, Gabriele

    2016-01-01

    Background Sleeping sickness (human African trypanosomiasis [HAT]) is caused by protozoan parasites and characterized by a chronic progressive course, which may last up to several years before death. We conducted two Phase 2 studies to determine the efficacy and safety of oral pafuramidine in African patients with first stage HAT. Methods The Phase 2a study was an open-label, non-controlled, proof-of-concept study where 32 patients were treated with 100 mg of pafuramidine orally twice a day (BID) for 5 days at two trypanosomiasis reference centers (Angola and the Democratic Republic of the Congo [DRC]) between August 2001 and November 2004. The Phase 2b study compared pafuramidine in 41 patients versus standard pentamidine therapy in 40 patients. The Phase 2b study was open-label, parallel-group, controlled, randomized, and conducted at two sites in the DRC between April 2003 and February 2007. The Phase 2b study was then amended to add an open-label sequence (Phase 2b-2), where 30 patients received pafuramidine for 10 days. The primary efficacy endpoint was parasitologic cure at 24 hours (Phase 2a) or 3 months (Phase 2b) after treatment completion. The primary safety outcome was the rate of occurrence of World Health Organization Toxicity Scale Grade 3 or higher adverse events. All subjects provided written informed consent. Findings/Conclusion Pafuramidine for the treatment of first stage HAT was comparable in efficacy to pentamidine after 10 days of dosing. The cure rates 3 months post-treatment were 79% in the 5-day pafuramidine, 100% in the 7-day pentamidine, and 93% in the 10-day pafuramidine groups. In Phase 2b, the percentage of patients with at least 1 treatment-emergent adverse event was notably higher after pentamidine treatment (93%) than pafuramidine treatment for 5 days (25%) and 10 days (57%). These results support continuation of the development program for pafuramidine into Phase 3. PMID:26881924

  19. Efficacy, Safety, and Dose of Pafuramidine, a New Oral Drug for Treatment of First Stage Sleeping Sickness, in a Phase 2a Clinical Study and Phase 2b Randomized Clinical Studies.

    PubMed

    Burri, Christian; Yeramian, Patrick D; Allen, James L; Merolle, Ada; Serge, Kazadi Kyanza; Mpanya, Alain; Lutumba, Pascal; Mesu, Victor Kande Betu Ku; Bilenge, Constantin Miaka Mia; Lubaki, Jean-Pierre Fina; Mpoto, Alfred Mpoo; Thompson, Mark; Munungu, Blaise Fungula; Manuel, Francisco; Josenando, Théophilo; Bernhard, Sonja C; Olson, Carol A; Blum, Johannes; Tidwell, Richard R; Pohlig, Gabriele

    2016-02-01

    Sleeping sickness (human African trypanosomiasis [HAT]) is caused by protozoan parasites and characterized by a chronic progressive course, which may last up to several years before death. We conducted two Phase 2 studies to determine the efficacy and safety of oral pafuramidine in African patients with first stage HAT. The Phase 2a study was an open-label, non-controlled, proof-of-concept study where 32 patients were treated with 100 mg of pafuramidine orally twice a day (BID) for 5 days at two trypanosomiasis reference centers (Angola and the Democratic Republic of the Congo [DRC]) between August 2001 and November 2004. The Phase 2b study compared pafuramidine in 41 patients versus standard pentamidine therapy in 40 patients. The Phase 2b study was open-label, parallel-group, controlled, randomized, and conducted at two sites in the DRC between April 2003 and February 2007. The Phase 2b study was then amended to add an open-label sequence (Phase 2b-2), where 30 patients received pafuramidine for 10 days. The primary efficacy endpoint was parasitologic cure at 24 hours (Phase 2a) or 3 months (Phase 2b) after treatment completion. The primary safety outcome was the rate of occurrence of World Health Organization Toxicity Scale Grade 3 or higher adverse events. All subjects provided written informed consent. Pafuramidine for the treatment of first stage HAT was comparable in efficacy to pentamidine after 10 days of dosing. The cure rates 3 months post-treatment were 79% in the 5-day pafuramidine, 100% in the 7-day pentamidine, and 93% in the 10-day pafuramidine groups. In Phase 2b, the percentage of patients with at least 1 treatment-emergent adverse event was notably higher after pentamidine treatment (93%) than pafuramidine treatment for 5 days (25%) and 10 days (57%). These results support continuation of the development program for pafuramidine into Phase 3.

  20. Application of the Stable Isotope Label Approach in Clinical Development-Supporting Dissolution Specifications for a Commercial Tablet Product with Tafenoquine, a Long Half-life Compound.

    PubMed

    Goyal, Navin; Mohamed, Khadeeja; Rolfe, Katie; Sahota, Satty; Ernest, Terry; Duparc, Stephan; Taylor, Maxine; Casillas, Linda; Koh, Gavin C K W

    2018-06-04

    Bioavailability/bioequivalence studies supporting clinical drug development or commercial supply of drug formulations are often time, cost, and resource intensive. The drug's pharmacokinetic (PK) variability, systemic half-life, and safety issues may pose additional challenges. The stable isotope label (SIL) approach provides a useful tool to significantly reduce the study size in clinical PK studies. Tafenoquine (TQ) is an 8-aminoquinoline under development for preventing Plasmodium vivax malaria relapse. This SIL study assessed the impact of differences in the in vitro dissolution profiles on in vivo exposure of TQ tablets. Fourteen healthy volunteers received a single dose of 300 mg TQ Intermediate Aged or 300 mg TQ Control formulations in this single-center, two-arm, randomized, open-label, parallel-group study. Endpoints included the geometric means ratio of the area under the concentration-time curve (AUC (0-t) and AUC (0-∞) ; primary endpoint) and maximum plasma concentration (C max ) for Intermediate Aged versus Control TQ; correlation of PK parameters for venous versus peripheral (via microsample) blood samples; and safety and tolerability endpoints. Geometric mean ratios for PK parameters (AUC and C max ) and their 90% confidence intervals fell well within standard bioequivalence limits (0.80-1.25). Only one mild adverse event (skin abrasion) was reported. In summary, this SIL methodology-based study demonstrates that the observed differences in the in vitro dissolution profiles between the Control and Intermediate Aged TQ tablets have no clinically relevant effect on systemic TQ exposure. The SIL approach was successfully implemented to enable the setting of a clinically relevant dissolution specification. This study (GSK study number 201780) is registered at clinicaltrials.gov with identifier NCT02751294.

  1. Long-term safety and efficacy of a novel once-weekly oral trelagliptin as monotherapy or in combination with an existing oral antidiabetic drug in patients with type 2 diabetes mellitus: A 52-week open-label, phase 3 study.

    PubMed

    Inagaki, Nobuya; Sano, Hiroki; Seki, Yoshifumi; Kuroda, Shingo; Kaku, Kohei

    2016-09-01

    Trelagliptin is a novel once-weekly oral dipeptidyl peptidase-4 inhibitor for type 2 diabetes mellitus that was first approved in Japan. We evaluated long-term safety and efficacy of trelagliptin in Japanese patients with type 2 diabetes mellitus. This was a phase 3, multicenter, open-label study to evaluate long-term safety and efficacy of trelagliptin. Patients with type 2 diabetes mellitus inadequately controlled despite diet/exercise or treatment with one of the existing oral antidiabetic drugs along with diet/exercise received trelagliptin 100 mg orally once weekly for 52 weeks as monotherapy or combination therapies. The primary end-points were the safety variables, and the secondary end-points were glycosylated hemoglobin and fasting plasma glucose. A total of 680 patients received the following antidiabetic therapies: trelagliptin monotherapy (n = 248), combination with a sulfonylurea (n = 158), a glinide (n = 67), an α-glucosidase inhibitor (n = 65), a biguanide (n = 70), or a thiazolidinedione (n = 72). During the study, 79.8% of the patients experienced at least one adverse event for monotherapy, 87.3% for combination with a sulfonylurea, 77.6% for a glinide, 81.5% for an α-glucosidase inhibitor, 64.3% for a biguanide, and 84.7% for a thiazolidinedione, respectively. Most of the adverse events were mild or moderate. The change in glycosylated hemoglobin from baseline at the end of the treatment period was -0.74 to -0.25% for each therapy. Once-weekly oral trelagliptin provides well-tolerated long-term safety and efficacy in both monotherapy and combination therapies in Japanese patients with type 2 diabetes mellitus. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  2. Simvastatin prescribing patterns before and after FDA dosing restrictions: a retrospective analysis of a large healthcare claims database.

    PubMed

    Tuchscherer, Rhianna M; Nair, Kavita; Ghushchyan, Vahram; Saseen, Joseph J

    2015-02-01

    Muscle-related events, or myopathies, are a commonly reported adverse event associated with statin use. In June 2011, the US FDA released a Drug Safety Communication that provided updated product labeling with dosing restrictions for simvastatin to minimize the risk of myopathies. Our objective was to describe prescribing patterns of simvastatin in combination with medications known to increase the risk of myopathies following updated product labeling dosing restrictions in June 2011. A retrospective observational analysis was carried out, in which administrative claims data were utilized to identify prescribing patterns of simvastatin in combination with calcium channel blockers (CCBs) and other pre-specified drug therapies. Prescribing patterns were analyzed on a monthly basis 24 months prior to and 9 months following product label changes. Incidence of muscle-related events was also analyzed. In June 2011, a total of 60% of patients with overlapping simvastatin-CCB claims and 94% of patients with overlapping simvastatin-non-CCB claims were prescribed an against-label combination. As of March 2012, a total of 41% and 93% of patients continued to be prescribed against-label simvastatin-CCB and simvastatin-non-CCB combinations, respectively. The most commonly prescribed dose of simvastatin was 20 mg (39%). Against-label combinations were most commonly prescribed at a simvastatin dose of 40 mg (56%). Amlodipine was the most commonly prescribed CCB in combination with simvastatin (70%) and the most common CCB prescribed against-label (67%). Despite improvements in prescribing practices, many patients are still exposed to potentially harmful simvastatin combinations. Aggressive changes in simvastatin prescribing systems and processes are needed to improve compliance with FDA labeling to improve medication and patient safety.

  3. Regulatory and ethical issues with dietary supplements.

    PubMed

    Harris, I M

    2000-11-01

    Dietary supplements are commonly used, and many are effective or hold promise for treating various conditions. However, they do not require Food and Drug Administration (FDA) approval. Impurities and adulterants have been found in the products, mostly due to the lack of requirements for good manufacturing practices. In addition, as no standardization is required, the active ingredient may be absent or highly variable among manufacturers. The FDA published its 10-year plan for dietary supplements that addresses safety, labeling, boundaries, enforcement, research, and outreach. This endeavor, if put into place, will be instrumental in providing consumers with more confidence in the safety, composition, and labeling of dietary supplements.

  4. An open-label, two-period comparative study on pharmacokinetics and safety of a combined ethinylestradiol/gestodene transdermal contraceptive patch.

    PubMed

    Zhang, Chao; Li, Haiyan; Xiong, Xin; Zhai, Suodi; Wei, Yudong; Zhang, Shuang; Zhang, Yuanyuan; Xu, Lin; Liu, Li

    2017-01-01

    We investigated the pharmacokinetics and safety profiles of a newly developed combined ethinylestradiol (EE)/gestodene (GSD) transdermal contraceptive patch after a single-dose administration and compared with the market available tablet formulation in healthy adult subjects. An open-label, two-period comparative study was conducted in 12 healthy women volunteers. A single dose of the study combined EE/GE transdermal contraceptive patch and oral tablet (Milunet ® ) were administered. Blood samples at different time points after dose were collected, and concentrations were analyzed. A reliable, highly sensitive and accurate high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC/MS/MS) assay method was developed in this study to determine the plasma concentrations of EE and GSD. Compared to the tablet, the study patch had a significantly decreased maximum plasma concentration ( C max ), extended time to reach the C max and half-life, as well as increased clearance and apparent volume of distribution. The half-lives of EE and GSD of the patch were 3.3 and 2.2 times, respectively, than the half-life of the tablet. The areas under the plasma concentration-time curve (AUCs) of EE and GSD of the patch were 8.0 and 16.2 times, respectively, than the AUC of the tablet. No severe adverse event was observed during the whole study, and the general safety was acceptable. In conclusion, compared to the oral tablet Milunet, the study contraceptive patch was well tolerated and showed potent drug exposure, significant extended half-life and stable drug concentrations.

  5. POISON POLITICS: A Contentious History of Consumer Protection Against Dangerous Household Chemicals in the United States

    PubMed Central

    Benrubi, Isidore Daniel

    2013-01-01

    The history of consumer protection against household poisons presents a key case study of the uniquely American struggle to balance public health and safety with the interests of business. By the late 19th century, package designs, warning labels, and state statutes had formed an uneven patchwork of protective mechanisms against accidental poisonings. As household chemicals proliferated in the early 20th century, physicians concerned with childhood poisonings pressured the federal government to enact legislation mandating warning labels on packaging for these substances. Manufacturers of household chemicals agreed to labeling requirements for caustic poisons but resisted broader regulation. Accidental poisonings of children continued to increase until the enactment of broad labeling and packaging legislation in the 1960s and 1970s. This history suggests that voluntary agreements between government agencies and manufacturers are inadequate to protect consumers against household poisonings and that, in the United States, protective household chemical regulation proceeds in a reactive rather than a precautionary manner. PMID:23488510

  6. Poison politics: a contentious history of consumer protection against dangerous household chemicals in the United States.

    PubMed

    Jones, Marian Moser; Benrubi, Isidore Daniel

    2013-05-01

    The history of consumer protection against household poisons presents a key case study of the uniquely American struggle to balance public health and safety with the interests of business. By the late 19th century, package designs, warning labels, and state statutes had formed an uneven patchwork of protective mechanisms against accidental poisonings. As household chemicals proliferated in the early 20th century, physicians concerned with childhood poisonings pressured the federal government to enact legislation mandating warning labels on packaging for these substances. Manufacturers of household chemicals agreed to labeling requirements for caustic poisons but resisted broader regulation. Accidental poisonings of children continued to increase until the enactment of broad labeling and packaging legislation in the 1960s and 1970s. This history suggests that voluntary agreements between government agencies and manufacturers are inadequate to protect consumers against household poisonings and that, in the United States, protective household chemical regulation proceeds in a reactive rather than a precautionary manner.

  7. Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period.

    PubMed

    Kadowaki, Takashi; Kondo, Kazuoki; Sasaki, Noriyuki; Miyayama, Kyoko; Yokota, Shoko; Terata, Ryuji; Gouda, Maki

    2017-09-01

    To assess the efficacy and safety of teneligliptin as add-on to insulin monotherapy in patients with type 2 diabetes mellitus (T2DM). In a 16-week, double-blind period, 148 Japanese T2DM patients with inadequate glycemic control with insulin and diet/exercise therapies were randomized to placebo or teneligliptin 20 mg. In a subsequent 36-week, open-label period, all patients received teneligliptin once daily. The primary outcome measure was change in HbA1c at the end of the double-blind period. The difference between placebo and teneligliptin in change in HbA1c in the double-blind period (least squares mean ± SE) was -0.80% ± 0.11%; teneligliptin was superior (ANCOVA, P < 0.001). The HbA1c-lowering effect of teneligliptin was maintained throughout the open-label period. The incidence of adverse events was 53.5% with placebo and 44.2% with teneligliptin in the double-blind period, 66.7% in the placebo/teneligliptin group in the open-label period, and 77.9% in the teneligliptin/teneligliptin group over both double-blind/open-label periods. The incidence of hypoglycemic symptoms was 11.1% in the placebo/teneligliptin group in the open-label period and 27.3% in the teneligliptin/teneligliptin group over both double-blind/open-label periods. Teneligliptin was effective and well tolerated in Japanese T2DM patients with inadequate glycemic control. NCT02081599.

  8. 16 CFR § 1209.31 - Purpose and applicability.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Section § 1209.31 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT... manufacturers, importers, and private labelers must follow to certify that their products comply with the... permanent or temporary household or residence, a school, in recreation or otherwise. The standard applies to...

  9. Informing Workers of Chemical Hazards: The OSHA Hazard Communication Standard.

    ERIC Educational Resources Information Center

    American Chemical Society, Washington, DC.

    Practical information on how to implement a chemical-related safety program is outlined in this publication. Highlights of the federal Occupational Safety and Health Administrations (OSHA) Hazard Communication Standard are presented and explained. These include: (1) hazard communication requirements (consisting of warning labels, material safety…

  10. Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data.

    PubMed

    Ma, Handong; Weng, Chunhua

    2016-04-01

    To link public data resources for predicting post-marketing drug safety label changes by analyzing the Convergent Focus Shift patterns among drug testing trials. We identified 256 top-selling prescription drugs between 2003 and 2013 and divided them into 83 BBW drugs (drugs with at least one black box warning label) and 173 ROBUST drugs (drugs without any black box warning label) based on their FDA black box warning (BBW) records. We retrieved 7499 clinical trials that each had at least one of these drugs for intervention from the ClinicalTrials.gov. We stratified all the trials by pre-marketing or post-marketing status, study phase, and study start date. For each trial, we retrieved drug and disease concepts from clinical trial summaries to model its study population using medParser and SNOMED-CT. Convergent Focus Shift (CFS) pattern was calculated and used to assess the temporal changes in study populations from pre-marketing to post-marketing trials for each drug. Then we selected 68 candidate drugs, 18 with BBW warning and 50 without, that each had at least nine pre-marketing trials and nine post-marketing trials for predictive modeling. A random forest predictive model was developed to predict BBW acquisition incidents based on CFS patterns among these drugs. Pre- and post-marketing trials of BBW and ROBUST drugs were compared to look for their differences in CFS patterns. Among the 18 BBW drugs, we consistently observed that the post-marketing trials focused more on recruiting patients with medical conditions previously unconsidered in the pre-marketing trials. In contrast, among the 50 ROBUST drugs, the post-marketing trials involved a variety of medications for testing their associations with target intervention(s). We found it feasible to predict BBW acquisitions using different CFS patterns between the two groups of drugs. Our random forest predictor achieved an AUC of 0.77. We also demonstrated the feasibility of the predictor for identifying long-term BBW acquisition events without compromising prediction accuracy. This study contributes a method for post-marketing pharmacovigilance using Convergent Focus Shift (CFS) patterns in clinical trial study populations mined from linked public data resources. These signals are otherwise unavailable from individual data resources. We demonstrated the added value of linked public data and the feasibility of integrating ClinicalTrials.gov summaries and drug safety labels for post-marketing surveillance. Future research is needed to ensure better accessibility and linkage of heterogeneous drug safety data for efficient pharmacovigilance. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. 16 CFR § 1500.20 - Labeling requirement for advertising toys and games.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... and games. § 1500.20 Section § 1500.20 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... ENFORCEMENT REGULATIONS § 1500.20 Labeling requirement for advertising toys and games. (a) Scope. This section..., that is used in various children's games, generally as a playing piece or marker. The term “marble...

  12. 9 CFR 590.680 - Approval of labeling for egg products processed in exempted egg products processing plants.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Approval of labeling for egg products processed in exempted egg products processing plants. 590.680 Section 590.680 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF...

  13. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.330 Unauthorized use...

  14. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.330 Unauthorized use...

  15. 9 CFR 381.138 - Unauthorized use or disposition of approved labeling or devices.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Unauthorized use or disposition of approved labeling or devices. 381.138 Section 381.138 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION...

  16. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.330 Unauthorized use...

  17. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.330 Unauthorized use...

  18. 75 FR 52427 - Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-25

    ... Affordable Care Act of 2010 (Affordable Care Act) establishes requirements for nutrition labeling of standard..., Rockville, MD 20852. Submit written requests for single copies of the guidance to the Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug...

  19. 9 CFR 590.680 - Approval of labeling for egg products processed in exempted egg products processing plants.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Approval of labeling for egg products processed in exempted egg products processing plants. 590.680 Section 590.680 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF...

  20. Magnetic Resonance Imaging Tracking of Ferumoxytol-Labeled Human Neural Stem Cells: Studies Leading to Clinical Use

    PubMed Central

    Gutova, Margarita; Frank, Joseph A.; D'Apuzzo, Massimo; Khankaldyyan, Vazgen; Gilchrist, Megan M.; Annala, Alexander J.; Metz, Marianne Z.; Abramyants, Yelena; Herrmann, Kelsey A.; Ghoda, Lucy Y.; Najbauer, Joseph; Brown, Christine E.; Blanchard, M. Suzette; Lesniak, Maciej S.; Kim, Seung U.; Barish, Michael E.

    2013-01-01

    Numerous stem cell-based therapies are currently under clinical investigation, including the use of neural stem cells (NSCs) as delivery vehicles to target therapeutic agents to invasive brain tumors. The ability to monitor the time course, migration, and distribution of stem cells following transplantation into patients would provide critical information for optimizing treatment regimens. No effective cell-tracking methodology has yet garnered clinical acceptance. A highly promising noninvasive method for monitoring NSCs and potentially other cell types in vivo involves preloading them with ultrasmall superparamagnetic iron oxide nanoparticles (USPIOs) to enable cell tracking using magnetic resonance imaging (MRI). We report here the preclinical studies that led to U.S. Food and Drug Administration approval for first-in-human investigational use of ferumoxytol to label NSCs prior to transplantation into brain tumor patients, followed by surveillance serial MRI. A combination of heparin, protamine sulfate, and ferumoxytol (HPF) was used to label the NSCs. HPF labeling did not affect cell viability, growth kinetics, or tumor tropism in vitro, and it enabled MRI visualization of NSC distribution within orthotopic glioma xenografts. MRI revealed dynamic in vivo NSC distribution at multiple time points following intracerebral or intravenous injection into glioma-bearing mice that correlated with histological analysis. Preclinical safety/toxicity studies of intracerebrally administered HPF-labeled NSCs in mice were also performed, and they showed no significant clinical or behavioral changes, no neuronal or systemic toxicities, and no abnormal accumulation of iron in the liver or spleen. These studies support the clinical use of ferumoxytol labeling of cells for post-transplant MRI visualization and tracking. PMID:24014682

  1. Long-term efficacy and safety of certolizumab pegol in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: 52-week results from an open-label extension of the J-RAPID study

    PubMed Central

    Tanaka, Yoshiya; Yamamoto, Kazuhiko; Takeuchi, Tsutomu; Yamanaka, Hisashi; Ishiguro, Naoki; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Shoji, Toshiharu; Miyasaka, Nobuyuki; Koike, Takao

    2014-01-01

    Abstract Objectives. To evaluate the long-term efficacy and safety of certolizumab pegol (CZP) plus methotrexate treatment and to assess the efficacy of two CZP maintenance dosing schedules in Japanese rheumatoid arthritis (RA) patients with an inadequate response to methotrexate. Methods. J-RAPID double-blind patients were entered into an open-label extension (OLE) study. Patients withdrawn due to lack of efficacy at 16 weeks and double-blind completers without a week-24 American College of Rheumatology (ACR) 20 response received CZP 200 mg every other week (Q2W) plus methotrexate. Double-blind completers with week-24 ACR20 responses were randomized to CZP 200 mg Q2W plus methotrexate or CZP 400 mg every 4 weeks plus methotrexate. Results. The ACR20/ACR50/ACR70 response rates of double-blind completers (n = 204) were 89.7%/67.2%/36.3% at OLE entry and 95.6%/84.8%/58.3% at 52 weeks, respectively. Other clinical, functional and radiographic outcomes were sustained with long-term CZP plus methotrexate. Long-term treatment with CZP was well-tolerated with no new unexpected adverse events observed. The efficacy and safety of CZP treatment were similar between the two dosing schedules. Conclusions. Continued CZP administration with methotrexate maintained efficacy over 52 weeks and was well-tolerated for Japanese RA patients. No obvious differences in clinical efficacy and safety were observed between the two dosing schedules, giving flexibility in maintenance administration schedules. PMID:24593170

  2. Safety of an Escherichia coli-expressed bivalent human papillomavirus (types 16 and 18) L1 virus-like particle vaccine: an open-label phase I clinical trial.

    PubMed

    Hu, Yue-Mei; Huang, Shou-Jie; Chu, Kai; Wu, Ting; Wang, Zhong-Ze; Yang, Chang-Lin; Cai, Jia-Ping; Jiang, Han-Min; Wang, Yi-Jun; Guo, Meng; Liu, Xiao-Hui; Huang, Hong-Jiang; Zhu, Feng-Cai; Zhang, Jun; Xia, Ning-Shao

    2014-01-01

    An Escherichia coli-expressed recombinant bivalent human papillomavirus (types 16 and 18) vaccine candidate has been shown to be safe and immunogenic in preclinical trials. The safety of this vaccine was analyzed in an open-label phase I clinical trial in Jiangsu province, China. Thirty-eight healthy women from 18 to 55 y of age were enrolled and vaccinated at 0, 1, and 6 mo. Adverse events that occurred within 30 d after each injection and serious adverse events that occurred throughout the study were recorded. In addition, blood parameters were tested before and after each injection. All but one woman received all 3 doses. Thirty-two (84.2%) of the participants reported adverse events, all adverse events of which were mild, of short duration and resolved spontaneously. No serious adverse events occurred during the study. Changes in blood parameters after each injection were random, mild, and not clinically significant. These preliminary results show that a new Escherichia coli-expressed recombinant HPV 16/18 bivalent vaccine is well tolerated in healthy women and support further immunogenicity and efficacy studies for this HPV vaccine candidate.

  3. Safety and efficacy of canagliflozin in Japanese patients with type 2 diabetes mellitus: post hoc subgroup analyses according to body mass index in a 52-week open-label study.

    PubMed

    Inagaki, Nobuya; Goda, Maki; Yokota, Shoko; Maruyama, Nobuko; Iijima, Hiroaki

    2015-01-01

    The safety and efficacy of sodium glucose co-transporter 2 inhibitors in non-obese compared with obese patients with type 2 diabetes mellitus is unknown. We conducted post hoc analyses of the results of a 52-week open-label study of Japanese type 2 diabetes mellitus patients treated with 100 or 200 mg canagliflozin. Patients were divided into four subgroups according to their baseline body mass index (BMI): group I, BMI < 22 kg/m(2); group II, BMI ≥ 22 to < 25 kg/m(2); group III, BMI ≥ 25 to < 30 kg/m(2) and group IV, BMI ≥ 30 kg/m(2). The overall safety was similar among the four BMI subgroups, although there were slight differences in terms of the incidences of hypoglycemia, asymptomatic hypoglycemia, female genital infections and proportions of patients with total ketone body levels exceeding 1000 μmol/l at any time for both canagliflozin doses. Hemoglobin A1c, fasting plasma glucose and body weight decreased significantly from baseline to week 52 at both canagliflozin doses. The changes in hemoglobin A1c, and fasting plasma glucose were not significantly different among the four BMI subgroups for either dose. Canagliflozin was tolerated in patients irrespective of their BMI at the start of treatment, although some caution may be needed.

  4. Pesticide use knowledge and practices: A gender differences in Nepal

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Atreya, Kishor

    It is important to understand gender difference on pesticide use knowledge, attitude and practices for identifying pesticide risks by gender and to recommend more gender-sensitive programs. However, very few studies have been conducted so far in Nepal. This study, thus, interviewed a total of 325 males and 109 females during 2005 to assess gender differences on pesticide use knowledge, attitude and practices. More than 50% females had never been to school and only <8% individuals were found trained in Integrated Pest Management (IPM). Almost all males and females did not smoke, drink and eat during pesticides application and also believedmore » that pesticides are harmful to human health, livestock, plant diversity and their environment. However, there were gender differences on household decision on pesticides to be used (p<0.001), care of wind direction during spraying (p=0.032), prior knowledge on safety measures (p=0.016), reading and understanding of pesticides labels (p<0.001), awareness of the labels (p<0.001) and protective covers. Almost all respondents were aware of negative impacts of pesticide use on human health and environment irrespective of gender; however, females were at higher risk due to lower level of pesticide use safety and awareness. It is strongly recommended to initiate gender-sensitive educational and awareness activities, especially on pesticide use practices and safety precautions.« less

  5. Development of cockroach immunotherapy by the Inner-City Asthma Consortium

    PubMed Central

    Wood, Robert A.; Togias, Alkis; Wildfire, Jeremy; Visness, Cynthia M.; Matsui, Elizabeth C.; Gruchalla, Rebecca; Hershey, Gurjit; Liu, Andrew H.; O’Connor, George T.; Pongracic, Jacqueline A.; Zoratti, Edward; Little, Frederic; Granada, Mark; Kennedy, Suzanne; Durham, Stephen R.; Shamji, Mohamed H.; Busse, William W.

    2014-01-01

    Background Cockroach allergy is a key contributor to asthma morbidity in children living in urban environments. Objective We sought to document immune responses to cockroach allergen and provide direction for the development of immunotherapy for cockroach allergy. Methods Four pilot studies were conducted: (1) an open-label study to assess the safety of cockroach sublingual immunotherapy (SLIT) in adults and children; (2) a randomized, double-blind biomarker study of cockroach SLIT versus placebo in adults; (3) a randomized, double-blind biomarker study of 2 doses of cockroach SLIT versus placebo in children; and (4) an open-label safety and biomarker study of cockroach subcutaneous immunotherapy (SCIT) in adults. Results The adult SLIT trial (n = 54; age, 18–54 years) found a significantly greater increase in cockroach-specific IgE levels between the active and placebo groups (geometric mean ratio, 1.92; P < .0001) and a trend toward increased cockroach-specific IgG4 levels in actively treated subjects (P = .09) but no evidence of functional blocking antibody response. The pediatric SLIT trial (n = 99; age, 5–17 years) found significant differences in IgE, IgG, and IgG4 responses between both active groups and the placebo group but no consistent differences between the high- and low-dose groups. In the SCIT study the treatment resulted in significant changes from baseline in cockroach IgE, IgG4, and blocking antibody levels. The safety profile of cockroach immunotherapy was reassuring in all studies. Conclusions The administration of cockroach allergen by means of SCIT is immunologically more active than SLIT, especially with regard to IgG4 levels and blocking antibody responses. No safety concerns were raised in any age group. These pilot studies suggest that immunotherapy with cockroach allergen is more likely to be effective with SCIT. PMID:24184147

  6. Safety, immunogenicity, and clinical outcomes in patients with Morquio A syndrome participating in 2 sequential open-label studies of elosulfase alfa enzyme replacement therapy (MOR-002/MOR-100), representing 5 years of treatment.

    PubMed

    Hendriksz, Christian; Santra, Saikat; Jones, Simon A; Geberhiwot, Tarekegn; Jesaitis, Lynne; Long, Brian; Qi, Yulan; Hawley, Sara M; Decker, Celeste

    2018-04-01

    Elosulfase alfa is an enzyme replacement therapy for Morquio A syndrome (mucopolysaccharidosis IVA), a multisystemic progressive lysosomal storage disorder. This report includes the primary treatment outcomes and immunogenicity profile of elosulfase alfa in patients with Morquio A syndrome from 2 sequential studies, MOR-002 (ClinicalTrials.govNCT00884949) and MOR-100 (NCT01242111), representing >5 years of clinical study data. MOR-002 was an open-label, single-arm phase 1/2 study that evaluated the pharmacokinetics, safety, immunogenicity, and preliminary efficacy of 3 sequential doses of elosulfase alfa (0.1, 1.0, and 2.0 mg/kg/week) in patients with Morquio A syndrome (n = 20) over 36 weeks, followed by an optional 36- to 48-week treatment period using elosulfase alfa 1.0 mg/kg once weekly (qw). During the 0.1 mg/kg dosing phase, 1 patient discontinued due to a type I hypersensitivity adverse event (AE), and that patient's sibling voluntarily discontinued in the absence of AEs. An additional patient discontinued due to recurrent infusion reactions during the 1.0 mg/kg continuation phase. The remaining 17 patients completed MOR-002 and enrolled in MOR-100, an open-label, long-term extension study that further evaluated safety and clinical outcomes with elosulfase alfa administered at 2.0 mg/kg qw. During the course of MOR-100, patients were given the option of receiving elosulfase alfa infusions at home with nursing assistance. Over the course of both studies, all patients experienced ≥1 AE and most patients experienced a drug-related AE, generally of mild or moderate severity. Hypersensitivity reactions reported as related to study drug occurred in 25% of patients. Thirteen patients who chose to receive infusions at home had the same tolerability and safety profile, as well as comparable compliance rates, as patients who chose to receive on-site infusions. All patients developed antibodies to elosulfase alfa. Positivity for neutralizing antibodies was associated with increased drug half-life and decreased drug clearance. Despite formation of antidrug-binding (total antidrug antibodies, TAb) and in vitro neutralizing antibodies (NAb) in all patients, these types of immunogenicity to elosulfase alfa were not correlated with safety or clinical outcomes. In contrast with the reported natural history of Morquio A, no trends toward decreasing endurance, respiratory function, or ability to perform activities of daily living were observed in this cohort over the 5-year period. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  7. Efficacy and safety of alternating norfloxacin and rifaximin as primary prophylaxis for spontaneous bacterial peritonitis in cirrhotic ascites: a prospective randomized open-label comparative multicenter study.

    PubMed

    Assem, M; Elsabaawy, M; Abdelrashed, M; Elemam, S; Khodeer, S; Hamed, W; Abdelaziz, A; El-Azab, G

    2016-03-01

    Primary prevention of spontaneous bacterial peritonitis (SBP) is an important strategy to reduce morbidity and mortality in cirrhotic patients with ascites. Efficacy and safety of alternating rifaximin and norfloxacin as primary prophylaxis is questionable. Three hundred thirty-four cirrhotic patients with high SAAG (≥1.1) ascites, protein level in ascitic fluid less than 1.5 g/dL with advanced liver disease (Child-Pugh score >9 points with serum bilirubin level >3 mg/dL) or renal impairment (serum creatinine level >1.2 mg/dL, blood urea nitrogen level >25 mg/dL, or serum sodium level <130 mEq/L) were included in an open-label, randomized study aimed at comparing alternating use of norfloxacin and rifaximin vs. norfloxacin or rifaximin alone as primary prophylaxis for SBP. Both intention-to-treat and per-protocol efficacy analyses were done after 6 months of treatment by assessment of ascitic fluid neutrophil count. Safety analysis was done for all intention-to-treat populations. Alternating norfloxacin and rifaximin showed superior prophylaxis by intention-to-treat (74.7 vs. 56.4% vs. 68.3%, p < 0.048). Pairwise analysis showed that alternating regimen had lower probability to develop SBP when compared to a norfloxacin-based regimen in intention-to-treat (p = 0.016) and per protocol analysis (p = 0.039). There was no difference among the studied groups regarding the incidence and severity of adverse events reported. Alternating norfloxacin- and rifaximin-based primary prophylaxis for SBP showed higher efficacy with the same safety profile when compared with monotherapy of norfloxacin.

  8. Pharmacokinetic Profile, Safety, and Tolerability of Crisaborole Topical Ointment, 2% in Adolescents with Atopic Dermatitis: An Open-Label Phase 2a Study.

    PubMed

    Tom, Wynnis L; Van Syoc, Merrie; Chanda, Sanjay; Zane, Lee T

    2016-01-01

    Phosphodiesterase-4 (PDE4) is an emerging target in treating inflammatory skin diseases. Crisaborole topical ointment, 2% is a novel, boron-based, topical PDE4 inhibitor under investigation for treatment of mild to moderate atopic dermatitis (AD). Adolescent patients aged 12 to 17 years with treatable AD lesions involving ≥ 10% to ≤ 35% body surface area (BSA) were enrolled into a phase 2a, open-label study comprising pharmacokinetic (PK), safety, tolerability, and efficacy assessments. Crisaborole topical ointment, 2% was applied twice daily to affected areas for 28 days, with dosage based on baseline treatable BSA. PK blood samples were collected on days 1, 2, 4, 6, 8, and 9. Safety assessments included adverse events (AEs), laboratory parameters, and vital signs. Efficacy assessments included the Investigator's Static Global Assessment (ISGA) score and severity of AD signs and symptoms. Twenty-three patients were enrolled; 22 completed the study (1 patient discontinued due to an AE [application site dermatitis]). PK analysis demonstrated limited exposure to crisaborole topical ointment, 2% after 8 days of dosing. Ten patients reported a total of 19 AEs, most commonly application site pain and nasopharyngitis (3 patients each). There were no clinically meaningful changes in laboratory or vital sign parameters. Efficacy was demonstrated by reductions in mean ISGA and AD sign and symptom severity scores. At day 29, eight patients (35%) had achieved an ISGA score ≤ 1 with ≥ 2-grade improvement. Mean treatable BSA declined from 17.6% to 8.2%. These results provide preliminary evidence for the limited systemic exposure, safety, and effectiveness of crisaborole topical ointment, 2% in adolescents with mild to moderate AD. © 2016 Wiley Periodicals, Inc.

  9. 78 FR 18306 - Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... properly labeled and packaged. Meat and poultry products not marked with the mark of inspection and shipped... it displays a currently valid OMB control number. Food Safety and Inspection Service Title... Collection: The Food Safety and Inspection Service (FSIS) has been delegated the authority to exercise the...

  10. Introduction to Pesticides. MP-18.

    ERIC Educational Resources Information Center

    Gale, Alvin F.

    This document is one in a series distributed by the Agricultural Extension Service of the University of Wyoming-Laramie. It provides an introduction to pesticides and is concerned with pesticide development, labeling and safety associated with the use, storage and disposal of these substances and their containers. Safety aspects of handling and…

  11. 24 CFR 3280.208 - Smoke alarm requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 5 2012-04-01 2012-04-01 false Smoke alarm requirements. 3280.208... URBAN DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Fire Safety § 3280.208 Smoke alarm requirements. (a) Labeling. Each smoke alarm required under paragraph (b) of this section must conform with the...

  12. 24 CFR 3280.208 - Smoke alarm requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 5 2013-04-01 2013-04-01 false Smoke alarm requirements. 3280.208... URBAN DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Fire Safety § 3280.208 Smoke alarm requirements. (a) Labeling. Each smoke alarm required under paragraph (b) of this section must conform with the...

  13. 24 CFR 3280.208 - Smoke alarm requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Smoke alarm requirements. 3280.208... URBAN DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Fire Safety § 3280.208 Smoke alarm requirements. (a) Labeling. Each smoke alarm required under paragraph (b) of this section must conform with the...

  14. 24 CFR 3280.208 - Smoke alarm requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 false Smoke alarm requirements. 3280.208... URBAN DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Fire Safety § 3280.208 Smoke alarm requirements. Link to an amendment published at 78 FR 73982, Dec. 9, 2013. (a) Labeling. Each smoke alarm...

  15. Safety Characteristics of Lithium Primary and Secondary Battery Systems. Formulation of a Lithium Battery Safety Matrix

    DTIC Science & Technology

    1986-07-01

    bags. 3) Cushioning of mineral wool , vermiculite or equivalent. Required labeling FLAMMABLE SOLID FLAMMABLE SOLID and DANGEROUS WHEN WET Authorized modes...or equivalent material such as mineral wool . Only permitted, hazardous waste transport companies may carry lithium batteries for disposal. The

  16. Gypcheck environmentally safe viral insecticide for gypsy moth control

    Treesearch

    Richard Reardon; John Podgwaite; Roger Zerillo

    2012-01-01

    This handbook is an update of handbook FHTET-2009-01, Gypchek - Bioinsecticide for the Gypsy Moth, printed in July, 2009. This update contains information on virus production, safety evaluations, results of efficacy and deposition evaluations, commercial production, and a copy of the revised registration label, material safety data sheet, and...

  17. 16 CFR 1118.2 - Conduct and scope of inspections.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Conduct and scope of inspections. 1118.2 Section 1118.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT... to and to copy all relevant records, books, documents, papers, packaging or labeling which: (i) Are...

  18. 49 CFR 575.301 - Vehicle Labeling of Safety Rating Information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... this section is to aid potential purchasers in the selection of new passenger motor vehicles by providing them with safety rating information developed by NHTSA in its New Car Assessment Program (NCAP... placed on new automobiles with the manufacturer's suggested retail price and other consumer information...

  19. A long-term, phase 2, multicenter, randomized, open-label, comparative safety study of pomaglumetad methionil (LY2140023 monohydrate) versus atypical antipsychotic standard of care in patients with schizophrenia

    PubMed Central

    2013-01-01

    Background We compared the time to discontinuation due to lack of tolerability over 24 weeks in patients suffering from schizophrenia treated with pomaglumetad methionil (LY2140023 monohydrate, the prodrug of metabotropic glutamate 2/3 receptor agonist, LY404039) or standard of care (SOC: olanzapine, risperidone, or aripiprazole). Methods Study HBBR was a multicenter, randomized, open-label study comparing the long-term safety and tolerability of LY2140023 with SOC for schizophrenia. Patients had moderate symptomatology with prominent negative symptoms and evidence of functional impairment. Those who met entry criteria were randomized to open-label treatment with either LY2140023 (target dose: 40 mg twice daily [BID]; n = 130) or SOC (n = 131). Results There was no statistically significant difference between LY2140023 and SOC for time to discontinuation due to lack of tolerability (primary objective; P = .184). The Kaplan-Meier estimates revealed comparable time to event profiles. Only 27% of LY2140023 and 45% of SOC patients completed the 24-week open-label, active treatment phase. Twenty-seven patients (20.8%) in the LY2140023 group and 15 patients (11.5%) in the SOC group discontinued due to lack of efficacy (P = .044). Twenty-three patients (17.7%) in the LY2140023 group and 19 patients (14.5%) in the SOC group discontinued due to adverse events (physician and subject decision combined, P = .505). The incidence of serious adverse events was comparable between groups. LY2140023-treated patients reported significantly more treatment-emergent adverse events of vomiting, agitation, and dyspepsia, while SOC-treated patients reported significantly more akathisia and weight gain. The incidence of treatment-emergent parkinsonism (P = .011) and akathisia (P = .029) was significantly greater in SOC group. Improvement in PANSS total score over the initial 6 to 8 weeks of treatment was similar between groups, but improvement was significantly greater in the SOC group at 24-week endpoint (P = .004). LY2140023 and SOC groups had comparable negative symptom improvement at 24-week endpoint (P = .444). Conclusion These data provide further evidence that the potential antipsychotic LY2140023 monohydrate, with a glutamatergic mechanism of action, may have a unique tolerability profile characterized by a low association with some adverse events such as extrapyramidal symptoms and weight gain that may characterize currently available dopaminergic antipsychotics. Trials registration A Long-term, Phase 2, Multicenter, Randomized, Open-label, Comparative Safety Study of LY2140023 Versus Atypical Antipsychotic Standard of Care in Patients with DSM-IV-TR Schizophrenia ClinicalTrials.gov identifier: NCT00845026. PMID:23694720

  20. Safety and efficacy of drugs in pregnancy.

    PubMed

    Knoppert, David

    2011-01-01

    Although most drugs are used to treat chronic or pregnancy-induced conditions during pregnancy and lactation, very few are studied in pregnant or breastfeeding women. The information we have on drugs taken during pregnancy and lactation is usually obtained after market approval through published case reports or case series and from pregnancy exposure or retrospective birth defect registries. Furthermore, generic drugs approved for use in this vulnerable population may be approved based on results from a male trial population. This disregards the changes that can occur during pregnancy which can affect the pharmacokinetics of drugs. In an effort to improve the information provided to prescribers, in 2008 the United States Food and Drug Administration proposed a change in product labelling where information from pregnancy exposure registries would be required. As of 2009, European Medicines Agency requires additional statements on use during pregnancy within drug labelling information. In Canada, it is anticipated that the efficacy and safety of drugs in pregnancy will be included under the Drug Safety and Effectiveness Network initiative, and that this will offer a unified approach for such assessments. Pregmedic, a non-profit organization for the advancement of safe and effective use of drugs in pregnancy, has presented a number of proposals and draft guidelines to Health Canada on the inclusion of pregnant women in pharmacokinetic studies and the establishment of registries for women who take drugs during pregnancy. Pregmedic advocates for ensuring that drugs indicated for women are studied in women.

  1. Understanding parental motivators and barriers to uptake of child poison safety strategies: a qualitative study.

    PubMed

    Gibbs, L; Waters, E; Sherrard, J; Ozanne-Smith, J; Robinson, J; Young, S; Hutchinson, A

    2005-12-01

    To develop an understanding of factors acting as barriers and motivators to parental uptake of child poison safety strategies. A qualitative study involving semistructured interviews and focus groups. A grounded theory approach was used for the collection and analysis of data. Sixty five parents of children under 5 years of age, some of whom had experienced an unintentional child poisoning incident. A range of knowledge based, environmental, and behavioral barriers to comprehensive parental uptake of poison safety practices were identified. As a result there tended to be only partial implementation of safety initiatives in the home. Selection of safety practices was often guided by the interests and behaviors of the child. This made the child vulnerable to changes in the home environment, inadequate supervision, and/or shifts in their own behavior and developmental ability. Personal or vicarious exposure of a parent to a child poisoning incident was a significant motivator for parental review of safety practices. Environmental measures targeting child resistant containers, warning labels, and lockable poisons cupboards will support parents' efforts to maintain poison safety. Additional education campaigns using stories of actual poisoning incidents may help to increase awareness of risk and encourage increased uptake.

  2. Long-term safety of once-daily, dual-release hydrocortisone in patients with adrenal insufficiency: a phase 3b, open-label, extension study

    PubMed Central

    Nilsson, Anna G; Bergthorsdottir, Ragnhildur; Burman, Pia; Dahlqvist, Per; Ekman, Bertil; Engström, Britt Edén; Ragnarsson, Oskar; Skrtic, Stanko; Wahlberg, Jeanette; Achenbach, Heinrich; Uddin, Sharif; Marelli, Claudio

    2017-01-01

    Objective To investigate the long-term safety and tolerability of a once-daily, dual-release hydrocortisone (DR-HC) tablet as oral glucocorticoid replacement therapy in patients with primary adrenal insufficiency (AI). Design Prospective, open-label, multicenter, 5-year extension study of DR-HC conducted at five university clinics in Sweden. Methods Seventy-one adult patients diagnosed with primary AI who were receiving stable glucocorticoid replacement therapy were recruited. Safety and tolerability outcomes included adverse events (AEs), intercurrent illness episodes, laboratory parameters and vital signs. Quality of life (QoL) was evaluated using generic questionnaires. Results Total DR-HC exposure was 328 patient-treatment years. Seventy patients reported 1060 AEs (323 per 100 patient-years); 85% were considered unrelated to DR-HC by the investigator. The most common AEs were nasopharyngitis (70%), fatigue (52%) and gastroenteritis (48%). Of 65 serious AEs reported by 32 patients (20 per 100 patient-years), four were considered to be possibly related to DR-HC: acute AI (n = 2), gastritis (n = 1) and syncope (n = 1). Two deaths were reported (fall from height and subarachnoid hemorrhage), both considered to be unrelated to DR-HC. From baseline to 5 years, intercurrent illness episodes remained relatively stable (mean 2.6–5.4 episodes per patient per year), fasting plasma glucose (0.7 mmol/L; P < 0.0001) and HDL cholesterol (0.2 mmol/L; P < 0.0001) increased and patient-/investigator-assessed tolerability improved. QoL total scores were unchanged but worsening physical functioning was recorded (P = 0.008). Conclusions In the first prospective study evaluating the long-term safety of glucocorticoid replacement therapy in patients with primary AI, DR-HC was well tolerated with no safety concerns observed during 5-year treatment. PMID:28292927

  3. Guselkumab, a human interleukin-23 monoclonal antibody in Japanese patients with generalized pustular psoriasis and erythrodermic psoriasis: Efficacy and safety analyses of a 52-week, phase 3, multicenter, open-label study.

    PubMed

    Sano, Shigetoshi; Kubo, Hiroshi; Morishima, Hitomi; Goto, Ryosuke; Zheng, Richuan; Nakagawa, Hidemi

    2018-05-01

    Generalized pustular psoriasis (GPP) and erythrodermic psoriasis (EP) are the rare and severe subtypes of psoriasis, which are often difficult to treat. The aim of this phase 3, open-label study was to evaluate efficacy and safety of guselkumab, a human interleukin-23 monoclonal antibody, in Japanese patients with GPP and EP. Guselkumab 50 mg was administrated to GPP (n = 10) and EP (n = 11) patients at weeks 0, 4 and thereafter every 8 weeks (q8w). Beginning at week 20, patients were escalated to 100 mg q8w if they met the dose escalation criteria. The primary end-point was the proportion of patients achieving treatment success (Clinical Global Impression score of "very much improved", "much improved" or "minimally improved") at week 16. Safety evaluations included assessment of treatment-emergent adverse events (TEAE) through week 52. At week 16, the proportions of GPP and EP patients achieving treatment success were 77.8% (7/9) and 90.9% (10/11), respectively. Furthermore, guselkumab treatment consistently showed improvement in responses of secondary end-points such as Psoriasis Area and Severity Index, Investigator's Global Assessment, Japanese Dermatological Association severity index and improvement in body surface area involvement. Improvements in quality of life, as assessed by the Dermatology Life Quality Index, were also observed through week 52. The most commonly reported TEAE was nasopharyngitis (28.6%, 6/21). Safety findings were consistent with those observed previously in other studies. In conclusion, guselkumab treatment demonstrated efficacy and showed no safety concerns in Japanese patients with GPP and EP through week 52. © 2018 Janssen Pharmaceutical K.K. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

  4. Off-label use of atypical antipsychotics: cause for concern?

    PubMed

    McKean, Andrew; Monasterio, Erik

    2012-05-01

    Licensed indications for medicines were designed to regulate the claims that can be made about a medicine by a pharmaceutical company. Off-label prescribing (i.e. prescribing a drug for an indication outside of that for which it is licensed) is legal and an integral part of medical practice. In psychiatry, off-label prescribing is common and gives clinicians scope to treat patients who are refractory to standard therapy or where there is no licensed medication for an indication. However, efficacy or safety of such off-label use may not be established. There is a growing list of licensed indications for atypical antipsychotics (AAP) beyond schizophrenia and bipolar affective disorder, and also more evidence for other indications where pharmaceutical companies have not obtained a license. Pharmaceutical companies have promoted AAPs for off-label indications to increase sales and consequently have been fined by the US FDA for this. Since the 1990s, AAP use has expanded considerably, for example, the off-label use of quetiapine alone accounted for an estimated 17% of the AAP spend in New Zealand in 2010. There are a number of potential problems with the expanded use of AAPs outside of schizophrenia and related psychoses. A larger population will be exposed to their adverse effects, which include weight gain, type 2 diabetes mellitus, sudden cardiac death and increased mortality rates in the elderly with dementia. There are also concerns with the abuse of these agents, in particular quetiapine. Given that an increasing percentage of the population is being treated with these agents, off-label prescribing of AAPs is a cause for concern; they have a propensity to cause significant side effects and their efficacy and long-term safety for most off-label indications remains largely unknown, and therefore the risks and benefits of their use should be carefully weighed up prior to prescribing these agents off-label.

  5. Off-label use of TNF-alpha inhibitors in a dermatological university department: retrospective evaluation of 118 patients.

    PubMed

    Sand, Freja Lærke; Thomsen, Simon Francis

    2015-01-01

    Tumor necrosis factor-alpha (TNF)-alpha inhibitors are licensed for patients with severe refractory psoriasis and psoriatic arthritis. However, TNF-alpha inhibitors have also been used off-label for various recalcitrant mucocutaneous diseases. This study aimed to evaluate the efficacy and safety of TNF-alpha inhibitors used for off-label dermatological indications. We retrospectively evaluated patient records of 118 patients treated off-label with TNF-alpha inhibitors in a dermatological university department. Patients presented with severe aphthous stomatitis/genital aphthous lesions (26), chronic urticaria (25), hidradenitis suppurativa (29), acne conglobata (11), dissecting cellulitis of the scalp (two), orofacial granulomatosis (four), sarcoidosis (four), granuloma annulare (two), granulomatous rosacea (one), granuloma faciale (one), subcorneal pustulosis (one), pyoderma gangrenosum (four), Sweet's syndrome (four), Well's syndrome (one), benign familial pemphigus (one), lichen planus (one), and folliculitis decalvans (one). A significant number of these patients went into remission during therapy with TNF-alpha inhibitors. A total of 11 patients (9%) experienced severe adverse effects during therapy. Off-label therapy with TNF-alpha inhibitors may be considered for selected patients with severe recalcitrant mucocutaneous diseases. The risk of severe adverse effects signals that a thorough benefit-risk assessment should be performed before initiating off-label treatment with TNF-alpha inhibitors for these conditions. © 2015 Wiley Periodicals, Inc.

  6. Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings.

    PubMed

    Cook, Daniel M; Gurugubelli, Rama K; Bero, Lisa A

    2009-01-01

    The US FDA increasingly applies risk management to drug safety policy. Little is known about the process by which the FDA approves labelling changes. Although advisory committees can recommend any of the risk management tools, including the use of 'black-box warnings', it is unknown whether they deliberate on these questions or how they apply the principles of risk minimization or management during their considerations of drug licensing. To examine the process by which risk management is considered by the FDA, including the role of FDA advisory committees. We also aimed to identify and describe drug labelling changes and additions, including the prevalence of black-box warnings. We electronically obtained publicly available information regarding drug approvals, drug revisions and advisory committee meetings over 3 years (2004-6) from the FDA. Data in the form of meeting transcripts and full histories of labelling changes were collected on drugs discussed by advisory committees. We then searched and qualitatively analysed the meeting transcripts to identify themes in the discussion. We also created a database of all prescription drug labelling changes for 3 years and examined which drugs have had the most changes. We describe the risk management consideration process and report the frequency and characteristics of labelling changes. Excerpts from the transcripts are selected to illustrate both typical and atypical features of the discussion. A total of 174 black-box changes were made in the 3-year period of our study, of which 77 were new black-box warnings and 97 were revisions in black-box warnings. Of 77 new black-box warning additions, only 11 drugs were discussed by the advisory committees. Of the 17 most frequently revised drug labels in these 3 years, two were discussed in the advisory committee meetings. Advisory meeting discussions revealed confusion about black-box warnings and emphasized potential consequences of the warnings rather than their content. The safety labelling of drugs on the market is changed often. Panels of advisors consider only a few drugs, rarely discuss the labelling requirements, and display confusion about applying black-box warnings. The creation and application of black-box warnings on prescription medications should receive closer attention from the FDA and its advisors.

  7. The effect of billboard design specifications on driving: A pilot study.

    PubMed

    Marciano, Hadas; Setter, Pe'erly

    2017-07-01

    Decades of research on the effects of advertising billboards on road accident rates, driver performance, and driver visual scanning behavior, has produced no conclusive findings. We suggest that road safety researchers should shift their focus and attempt to identify the billboard characteristics that are most distracting to drivers. This line of research may produce concrete guidelines for permissible billboards that would be likely to reduce the influence of the billboards on road safety. The current study is a first step towards this end. A pool of 161 photos of real advertising billboards was used as stimuli within a triple task paradigm designed to simulate certain components of driving. Each trial consisted of one ongoing tracking task accompanied by two additional concurrent tasks: (1) billboard observation task; and (2) circle color change identification task. Five clusters of billboards, identified by conducting a cluster analysis of their graphic content, were used as a within variable in one-way ANOVAs conducted on performance level data collected from the multiple tasks. Cluster 5, labeled Loaded Billboards, yielded significantly deteriorated performance on the tracking task. Cluster 4, labeled Graphical Billboards, yielded deteriorated performance primarily on the color change identification task. Cluster 3, labeled Minimal Billboards, had no effect on any of these tasks. We strongly recommend that these clusters be systematically explored in experiments involving additional real driving settings, such as driving simulators and field studies. This will enable validation of the current results and help incorporate them into real driving situations. Copyright © 2017. Published by Elsevier Ltd.

  8. 9 CFR 317.17 - Interpretation and statement of labeling policy for cured products; special labeling requirements...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Section 317.17 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... of such product. For example, curing mixtures composed of such ingredients as water, salt, sugar... thermally processed to Fo 3 or more; they have been fermented or pickled to pH of 4.6 or less; or they have...

  9. 9 CFR 317.17 - Interpretation and statement of labeling policy for cured products; special labeling requirements...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Section 317.17 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... of such product. For example, curing mixtures composed of such ingredients as water, salt, sugar... thermally processed to Fo 3 or more; they have been fermented or pickled to pH of 4.6 or less; or they have...

  10. 9 CFR 317.17 - Interpretation and statement of labeling policy for cured products; special labeling requirements...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Section 317.17 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... of such product. For example, curing mixtures composed of such ingredients as water, salt, sugar... thermally processed to Fo 3 or more; they have been fermented or pickled to pH of 4.6 or less; or they have...

  11. 76 FR 15364 - Reports, Forms and Record Keeping Requirements; Agency Information Collection Activity Under OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-21

    ... identification on their self-certification label on each piece of motor vehicle glazing. As part of that... manufacturer but is not required. FMVSS No. 209, ``Seat belt assemblies,'' requires safety belts to be labeled... sheet (S4.1(k)). Seat belt assemblies installed as original equipment in new motor vehicles need not be...

  12. 78 FR 49412 - Personal Flotation Devices Labeling and Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ...The Coast Guard proposes to remove references to type codes in its regulations on the carriage and labeling of Coast Guard-approved personal flotation devices (PFDs). PFD type codes are unique to Coast Guard approval and are not well understood by the public. Removing these type codes from our regulations would facilitate future incorporation by reference of new industry consensus standards for PFD labeling that will more effectively convey safety information, and is a step toward harmonization of our regulations with PFD requirements in Canada and in other countries.

  13. Challenges and Path Forward on Mandatory Allergen Labeling and Voluntary Precautionary Allergen Labeling for a Global Company.

    PubMed

    Yeung, Jupiter; Robert, Marie-Claude

    2018-01-01

    For food manufacturers, the label on a food package is a tool meant to alert consumers to the presence of specific allergens, allowing consumers to make informed decisions and not unnecessarily limit their food choices. Mandatory allergen labeling is used when the allergen is an intentionally added ingredient, whereas voluntary allergen labeling is used when the presence of the allergen is unintentional and may be in the finished product as a result of cross-contact. In a globalized economy, ensuring food safety is a growing challenge for manufacturers. When ingredients and technologies are sourced worldwide from multiple business partners, complexity rises, which can increase the chance for errors, leading to potential harm. Threshold science, Voluntary Incidental Trace Allergen Labelling (VITAL) reference doses, fit-for-purpose analytical technology, and common sense enable us to optimize allergen management for the benefit of allergic consumers. This is a good strategy because all stakeholders share the common goal of making foods safe and wholesome for all. Herein, we recommend that (1) senior management make science-based thresholds a priority for both regulatory authorities and the food industry; (2) VITAL 2.0 be adopted as a risk assessment and risk management tool for precautionary allergen labeling (PAL); (3) a standardized message for PAL, i.e., "may contain x," be used to make it easily understandable to allergic consumers so they can make informed food choices; and (4) validated fit-for-purpose allergen methods be used to meet analytical needs. This is an opportunity for us to speak with one voice and demonstrate that food safety is not a competitive issue, but a shared responsibility. This approach could significantly improve allergic consumers' lives.

  14. Packaging and Labeling of Pharmaceutical Products Obtained from the Internet

    PubMed Central

    2011-01-01

    Background For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product’s identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. Objective The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. Methods During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Results Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products’ packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Conclusions Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety. PMID:21324833

  15. Packaging and labeling of pharmaceutical products obtained from the internet.

    PubMed

    Veronin, Michael

    2011-02-15

    For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products' packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety.

  16. 75 FR 17828 - Michelin North America, Inc., Grant of Petition for Decision of Inconsequential Noncompliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-07

    ... inconsequentiality to motor vehicle safety in this case is that there is no effect of the noncompliances on the... retread, repair, and recycling industries must also be considered. Although tire construction affects the... labeling of the tire construction information will have an inconsequential effect on motor vehicle safety...

  17. 49 CFR 571.129 - Standard No. 129; New non-pneumatic tires for passenger cars.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 6 2010-10-01 2010-10-01 false Standard No. 129; New non-pneumatic tires for... VEHICLE SAFETY STANDARDS Federal Motor Vehicle Safety Standards § 571.129 Standard No. 129; New non... rating; and specifies labeling requirements for non-pneumatic spare tires. S2Application. This standard...

  18. 49 CFR 571.129 - Standard No. 129; New non-pneumatic tires for passenger cars.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 6 2011-10-01 2011-10-01 false Standard No. 129; New non-pneumatic tires for... VEHICLE SAFETY STANDARDS Federal Motor Vehicle Safety Standards § 571.129 Standard No. 129; New non... rating; and specifies labeling requirements for non-pneumatic spare tires. S2Application. This standard...

  19. 49 CFR 571.129 - Standard No. 129; New non-pneumatic tires for passenger cars.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 6 2014-10-01 2014-10-01 false Standard No. 129; New non-pneumatic tires for... VEHICLE SAFETY STANDARDS Federal Motor Vehicle Safety Standards § 571.129 Standard No. 129; New non... rating; and specifies labeling requirements for non-pneumatic spare tires. S2Application. This standard...

  20. 49 CFR 571.129 - Standard No. 129; New non-pneumatic tires for passenger cars.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 6 2012-10-01 2012-10-01 false Standard No. 129; New non-pneumatic tires for... VEHICLE SAFETY STANDARDS Federal Motor Vehicle Safety Standards § 571.129 Standard No. 129; New non... rating; and specifies labeling requirements for non-pneumatic spare tires. S2Application. This standard...

  1. Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial.

    PubMed

    Overton, Edgar Turner; Stapleton, Jack; Frank, Ian; Hassler, Shawn; Goepfert, Paul A; Barker, David; Wagner, Eva; von Krempelhuber, Alfred; Virgin, Garth; Meyer, Thomas Peter; Müller, Jutta; Bädeker, Nicole; Grünert, Robert; Young, Philip; Rösch, Siegfried; Maclennan, Jane; Arndtz-Wiedemann, Nathaly; Chaplin, Paul

    2015-04-01

    Background.  First- and second-generation smallpox vaccines are contraindicated in individuals infected with human immunodeficiency virus (HIV). A new smallpox vaccine is needed to protect this population in the context of biodefense preparedness. The focus of this study was to compare the safety and immunogenicity of a replication-deficient, highly attenuated smallpox vaccine modified vaccinia Ankara (MVA) in HIV-infected and healthy subjects. Methods.  An open-label, controlled Phase II trial was conducted at 36 centers in the United States and Puerto Rico for HIV-infected and healthy subjects. Subjects received 2 doses of MVA administered 4 weeks apart. Safety was evaluated by assessment of adverse events, focused physical exams, electrocardiogram recordings, and safety laboratories. Immune responses were assessed using enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT). Results.  Five hundred seventy-nine subjects were vaccinated at least once and had data available for analysis. Rates of ELISA seropositivity were comparably high in vaccinia-naive healthy and HIV-infected subjects, whereas PRNT seropositivity rates were higher in healthy compared with HIV-infected subjects. Modified vaccinia Ankara was safe and well tolerated with no adverse impact on viral load or CD4 counts. There were no cases of myo-/pericarditis reported. Conclusions.  Modified vaccinia Ankara was safe and immunogenic in subjects infected with HIV and represents a promising smallpox vaccine candidate for use in immunocompromised populations.

  2. A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration.

    PubMed

    van Asten, Freekje; Evers-Birkenkamp, Kim U; van Lith-Verhoeven, Janneke J C; de Jong-Hesse, Yvonne; Hoppenreijs, Vincent P T; Hommersom, Richard F; Scholten, Agnes M; Hoyng, Carel B; Klaver, Johannes H J

    2015-03-01

    The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice. The HELIOS study was a 2-year prospective, observational, open-label, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time-points 3, 6, 12, 18 and 24 months after inclusion. Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ-5D questionnaire, which did not significantly change over the study period. The more subjective EQ-VAS questionnaire showed an overall improvement. The VFQ-25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long-term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice. This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  3. Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants.

    PubMed

    Abdelnour, Arturo; Silas, Peter E; Lamas, Marta Raquel Valdés; Aragón, Carlos Fernándo Grazioso; Chiu, Nan-Chang; Chiu, Cheng-Hsun; Acuña, Teobaldo Herrera; Castrejón, Tirza De León; Izu, Allen; Odrljin, Tatjana; Smolenov, Igor; Hohenboken, Matthew; Dull, Peter M

    2014-02-12

    The highest risk for invasive meningococcal disease (IMD) is in infants aged <1 year. Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A, C, W and Y. This phase 3b, multinational, open-label, randomized, parallel-group, multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, concomitantly administered with routine vaccinations to healthy infants. Two-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2, 4, 6 and 12 months. Adverse events (AEs) that were medically attended and serious adverse events (SAEs) were collected from all subjects from enrollment through 18 months of age. In a subset, detailed safety data (local and systemic solicited reactions and all AEs) were collected for 7 days post vaccination. The primary objective was a non-inferiority comparison of the percentages of subjects with ≥1 severe systemic reaction during Days 1-7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone (criterion: upper limit of 95% confidence interval [CI] of group difference <6%). A total of 7744 subjects were randomized with 1898 in the detailed safety arm. The percentage of subjects with severe systemic reactions was 16% after MenACWY-CRM plus routine vaccines and 13% after routine vaccines alone (group difference 3.0% (95% CI -0.8, 6.4%). Although the non-inferiority criterion was not met, post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone (group difference -0.1% [95% CI -4.9%, 4.7%]). Rates of solicited AEs, medically attended AEs, and SAEs were similar across groups. In a large multinational safety study, a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable with a similar safety profile to routine vaccines given alone. Copyright © 2013 Elsevier Ltd. All rights reserved.

  4. Effectiveness and safety of generic version of abacavir/lamivudine and efavirenz in treatment naïve HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2011-2012.

    PubMed

    Galindo, Jaime; Amariles, Pedro; Mueses-Marín, Héctor F; Hincapié, Jaime A; González-Avendaño, Sebastián; Galindo-Orrego, Ximena

    2016-10-03

    Generic drug policies are often associated with concerns about the quality and effectiveness of these products. Phase IV clinical trials may be a suitable design to assess the effectiveness and safety of generic drugs. The objective of this study was to describe the effectiveness and the safety of the generic abacavir/lamivudine and efavirenz in treatment-naïve HIV-infected patients. A monocentric, nonrandomized, open-label, phase IV study in treatment naïve HIV-infected patients 18 years or older with indication to receive abacavir/lamivudine and efavirenz were recruited from a program that provides comprehensive outpatient consultation and continuing care. The primary end-point was to achieve viral load <40 copies/mL at 12 months after baseline to assess effectiveness. Secondary end-point of the study were 1) to asses increasing in T-CD4 lymphocytes levels as accompaniment to asses effectiveness, and 2) to assess both gastrointestinal, skin, and central nervous system symptoms, and lipid profile, cardiovascular risk, renal, and hepatic function as safety profile. Data were determined at baseline, 3, 6, and 12 months. Close clinical monitoring and pharmaceutical care were used for data collection. Wilcoxon matched-pairs signed-rank test was used to compare proportions or medians. Sixty patients were invited to participate in the study; 42 were enrolled and 33 completed the follow-up. Of the nine patients excluded from the study, only one was withdrawn due to adverse events. At 12 months, 31 of 42 patients (73.8 % in intention-to-treat analysis) achieved a viral load of HIV1 RNA <40 copies/mL. There was a significant increase (172 cells/mm 3 ) in the median for CD4 T lymphocyte count. The adverse events were mild and met the safety profile for this antiretroviral regimen, mainly of central nervous system symptoms, skin rash, lipid abnormalities, and an increase of 2 % in the median of the percentage of cardiovascular risk. The clinical outcomes of generic version of abacavir/lamivudine and efavirenz in HIV treatment naïve patients showed the expected safety and effectiveness profile of proprietary ARV drugs. Registro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000202 . Registered 19 November 2015.

  5. Visually impaired individuals, safety perceptions and traumatic events: a qualitative study of hazards, reactions and coping.

    PubMed

    Saur, Randi; Hansen, Marianne Bang; Jansen, Anne; Heir, Trond

    2017-04-01

    To explore the types of risks and hazards that visually impaired individuals face, how they manage potential threats and how reactions to traumatic events are manifested and coped with. Participants were 17 visually impaired individuals who had experienced some kind of potentially traumatic event. Two focus groups and 13 individual interviews were conducted. The participants experienced a variety of hazards and potential threats in their daily life. Fear of daily accidents was more pronounced than fear of disasters. Some participants reported avoiding help-seeking in unsafe situations due to shame at not being able to cope. The ability to be independent was highlighted. Traumatic events were re-experienced through a variety of sense modalities. Fear of labelling and avoidance of potential risks were recurring topics, and the risks of social withdrawal and isolation were addressed. Visual impairment causes a need for predictability and adequate information to increase and prepare for coping and self-efficacy. The results from this study call for greater emphasis on universal design in order to ensure safety and predictability. Fear of being labelled may inhibit people from using assistive devices and adequate coping strategies and seeking professional help in the aftermath of a trauma. Implications for Rehabilitation Visual impairment entails a greater susceptibility to a variety of hazards and potential threats in daily life. This calls for a greater emphasis on universal design in public spaces to ensure confidence and safety. Visual impairment implies a need for predictability and adequate information to prepare for coping and self-efficacy. Rehabilitation professionals should be aware of the need for independence and self-reliance, the possible fear of labelling, avoidance of help-seeking or reluctance to use assistive devices. In rehabilitation after accidents or potential traumatizing events, professionals' knowledge about the needs for information, training and predictability is crucial. The possibility of social withdrawal or isolation should be considered.

  6. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis.

    PubMed

    Ryan, Caitriona; Sobell, Jeffrey M; Leonardi, Craig L; Lynde, Charles W; Karunaratne, Mahinda; Valdecantos, Wendell C; Hendrickson, Barbara A

    2018-06-01

    Adalimumab is approved for the treatment of hidradenitis suppurativa (HS), plaque psoriasis, and other inflammatory conditions. Our objective was to examine the safety of adalimumab administered every other week (EOW) and every week (EW) in patients with HS and psoriasis and to investigate informative data from non-dermatologic indications. The safety of adalimumab 40-mg EOW versus EW dosing was examined during placebo-controlled and open-label study periods in patients with HS (three studies), psoriasis (two studies), Crohn's disease (six studies), ulcerative colitis (three studies), and rheumatoid arthritis (one study). No new safety risks or increased rates of particular adverse events (AEs) were identified with EW dosing. In patients with HS or psoriasis, the overall safety of adalimumab 40-mg EOW and EW was generally comparable. In studies of adalimumab for non-dermatologic indications, including Crohn's disease, ulcerative colitis, and rheumatoid arthritis, the overall AE rates were similar for EW and EOW dosing. In patients with HS or psoriasis, the safety of adalimumab EW and EOW was comparable and consistent with the expected adalimumab AE profile. The safety of adalimumab EW dosing in patients with dermatologic conditions is supported by data comparing adalimumab EW and EOW dosing for Crohn's disease, ulcerative colitis, and rheumatoid arthritis. ClinicalTrials.gov NCT00918255, NCT01468207, NCT01468233, NCT00645814, NCT00077779, NCT00055497, NCT01070303, NCT00195715, NCT00348283, NCT00385736, NCT00408629, and NCT00573794.

  7. Spinal cord stimulation: a review of the safety literature and proposal for perioperative evaluation and management.

    PubMed

    Walsh, Kevin M; Machado, Andre G; Krishnaney, Ajit A

    2015-08-01

    There is currently no consensus on appropriate perioperative management of patients with spinal cord stimulator implants. Magnetic resonance imaging (MRI) is considered safe under strict labeling conditions. Electrocautery is generally not recommended in these patients but sometimes used despite known risks. The aim was to discuss the perioperative evaluation and management of patients with spinal cord stimulator implants. A literature review, summary of device labeling, and editorial were performed, regarding the safety of spinal cord stimulator devices in the perioperative setting. A literature review was performed, and the labeling of each Food and Drug Administration (FDA)-approved spinal cord stimulation system was reviewed. The literature review was performed using PubMed and the FDA website (www.fda.gov). Magnetic resonance imaging safety recommendations vary between the models. Certain systems allow for MRI of the brain to be performed, and only one system allows for MRI of the body to be performed, both under strict labeling conditions. Before an MRI is performed, it is imperative to ascertain that the system is intact, without any lead breaks or low impedances, as these can result in heating of the spinal cord stimulation (SCS) and injury to the patient. Monopolar electrocautery is generally not recommended for patients with SCS; however, in some circumstances, it is used when deemed required by the surgeon. When cautery is necessary, bipolar electrocautery is recommended. Modern electrocautery units are to be used with caution as there remains a risk of thermal injury to the tissue in contact with the SCS. As with MRI, electrocautery usage in patients with SCS systems with suspected breaks or abnormal impedances is unsafe and may cause injury to the patient. Spinal cord stimulation is increasingly used in patients with pain of spinal origin, particularly to manage postlaminectomy syndrome. Knowledge of the safety concerns of SCS and appropriate perioperative evaluation and management of the SCS system can reduce risks and improve surgical planning. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. The MARCOPOLO Study of Ustekinumab Utilization and Efficacy in a Real-World Setting: Treatment of Patients with Plaque Psoriasis in Asia-Pacific Countries

    PubMed Central

    Youn, Sang Woong; Tsai, Tsen-Fang; Theng, Colin; Choon, Siew-Eng; Wiryadi, Benny E.; Pires, Antonio; Tan, Weihao

    2016-01-01

    Background Ustekinumab is a fully human monoclonal antibody approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults. However, factors including efficacy, tolerability, ease of use, and cost burden may affect ustekinumab utilization. Noncompliance may, in turn, affect treatment response. Objective To evaluate ustekinumab utilization in the real-world setting in Asia-Pacific countries. Methods In this phase 4 observational study conducted in Indonesia, Malaysia, Singapore, Korea, and Taiwan, adults with plaque psoriasis receiving ustekinumab were followed for up to 52 weeks. Study endpoints were the proportion of all patients using ustekinumab according to label-recommended intervals and the proportion of Korean patients who achieved a psoriasis area severity index 75 response at week 16. Safety was assessed by monitoring adverse events. Results Overall, 169 patients received ustekinumab (Korea, n=102; other countries, n=67). Just over half (56.2%) of patients used ustekinumab with the label-recommended interval from baseline to week 40; the proportion was higher in Korea (73.5%) than in other countries (29.9%), probably because ustekinumab was provided without charge for Korean patients up to week 40. Noncompliance increased after week 40 in Korea and from week 28 in other Asia-Pacific countries, with cost cited as the most common reason. At week 16, 56.9% of Korean patients achieved a Psoriasis Area Severity Index 75 response. Safety results were in line with those seen in previous studies. Conclusion More than half of all patients in Asia-Pacific countries used ustekinumab as per the label-recommended dose interval, but reimbursement variations between countries may have confounded overall results. PMID:27081271

  9. The safety and tolerability of rotigotine transdermal system over a 6-year period in patients with early-stage Parkinson's disease.

    PubMed

    Giladi, Nir; Boroojerdi, Babak; Surmann, Erwin

    2013-09-01

    This open-label extension (SP716; NCT00599196) of a 6-month, double-blind, randomized study (SP513) investigated the safety and tolerability of rotigotine transdermal system over up to ~6 years in patients with Parkinson's disease (PD; early-stage PD at double-blind enrollment). Eligible patients completing the 6-month study received optimal dose open-label rotigotine (≤ 16 mg/24 h) for up to ~6 years. Adjunctive levodopa was permitted. Primary outcomes included adverse events (AEs) and extent of rotigotine exposure. Analysis of adjunctive levodopa use, dyskinesias [unified Parkinson's disease rating scale (UPDRS) IV], and efficacy (UPDRS II + III total score) were also assessed. Of 381 patients enrolled in the open-label extension, 52 % were still in the study at time of closure; 24 % withdrew because of AEs and 6 % because of lack of efficacy. Patients received rotigotine for a median duration of 1,564.5 days (~4 years, 3 months; range 5-2, 145 days). 69 % of patients started supplemental levodopa; median time to levodopa was 485 days (~1 year, 4 months). Most common AEs (% per patient-year) were somnolence (18 %), application site reactions (12 %), nausea (9 %), peripheral edema (7 %), and fall (7 %). AEs indicative of impulsive-compulsive behavior were recorded in 25 (7 %) patients. Dyskinesias were experienced by 65 (17 %) patients; the majority [47 of 65 (72 %)] reported first dyskinesia after starting levodopa. Mean UPDRS II + III total scores remained below double-blind baseline for 4 years (assessment of all patients). In conclusion, rotigotine was generally well tolerated for up to ~6 years in patients with early-stage PD. The AEs reported were in line with previous studies of rotigotine transdermal system, with typical dopaminergic side effects and application site reactions seen.

  10. Rooting out institutional corruption to manage inappropriate off-label drug use.

    PubMed

    Rodwin, Marc A

    2013-01-01

    Prescribing drugs for uses that the FDA has not approved - off-label drug use - can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use. © 2013 American Society of Law, Medicine & Ethics, Inc.

  11. 9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

  12. 9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

  13. 9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

  14. 9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

  15. Reading the Small Print – Labelling Recommendations for Orthopaedic Implants

    PubMed Central

    Haene, Roger A; Sandhu, Ranbir S; Baxandall, Richard

    2009-01-01

    INTRODUCTION There exist, currently, no clear guidelines regarding standards for surgical implant labelling. Dimensions of the laminar flow canopies in orthopaedic use fixes the distance at which implant labels can be read. Mistakes when reading the label on an implant box can pose health risks for patients, and financial consequences for medical institutions. SUBJECTS AND METHODS Using scientifically validated tools such as the Snellen Chart Formula, a theoretical minimum standard for text on implant labels was reached. This theoretical standard was then tested under real operating conditions. After discovering a minimum practical standard for implant labels, the authors then audited current labels in use on a wide range of orthopaedic implant packages. Furthermore, other non-text-related labelling problems were also noted. RESULTS There is a definite minimum standard which should be observed when implant labels are manufactured. Implants in current use bear labels on the packaging that are of an insufficient standard to ensure patient safety in theatre. CONCLUSIONS The authors have established text parameters that will increase the legibility of implant labels. In the interests of improving risk management in theatre, therefore, the authors propose a standard for orthopaedic implant labelling, and believe this will provide a useful foundation for further discussion between the orthopaedic community and implant manufacturers. PMID:19686615

  16. Long-term safety and efficacy of canakinumab in cryopyrin-associated periodic syndrome: results from an open-label, phase III pivotal study in Japanese patients.

    PubMed

    Yokota, Shumpei; Imagawa, Tomoyuki; Nishikomori, Ryuta; Takada, Hidetoshi; Abrams, Ken; Lheritier, Karine; Heike, Toshio; Hara, Toshiro

    2017-01-01

    To assess the long-term safety and efficacy of canakinumab in Japanese patients with cryopyrin-associated periodic syndrome (CAPS). In this open-label phase 3 study, Japanese patients aged ≥2 years with CAPS received canakinumab 2-8 mg/kg subcutaneously every 8 weeks. The duration of the core treatment phase was 24 weeks followed by 22 months extension phase. The primary objective was the proportion of patients free of clinical and serologic relapse at week 24. The study enrolled 19 Japanese patients (median age, 14 years; range, 2-48 years) with CAPS [MWS, 7 (36.8%); NOMID, 12 (63.2%)] for a median of 109 weeks. Fifteen patients (79%) achieved a complete response by day 15, 18 (94.7%) by week 24 and all by week 48. At the end of the study, 18 (95%) were free from relapse and 11 (57.9%) were assessed as having no disease activity by the PGA. Thirteen (68%) patients (MWS, 4; NOMID, 9) had their canakinumab dose increased during the trial. All patients experienced at least one adverse event (AE), the most common being infections (100%) and 5 (26.3%) reported serious AEs. No deaths were reported and the only patient who discontinued the study early withdrew consent. Regular canakinumab treatment every 8 weeks at dose levels from 2-8 mg/kg, based on the clinical need, represents a successful strategy to induce rapid and complete response while maintain long-term disease control in Japanese patients with CAPS. The safety profile of canakinumab was consistent with that observed from previous studies.

  17. Label it or ban it? Public perceptions of nano-food labels and propositions for banning nano-food applications

    NASA Astrophysics Data System (ADS)

    Chuah, Agnes S. F.; Leong, Alisius D.; Cummings, Christopher L.; Ho, Shirley S.

    2018-02-01

    The future of nano-food largely hinges on public perceptions and willingness to accept this novel technology. The present study utilizes the scientific literacy model and psychometric paradigm as the key theoretical frameworks to examine the factors influencing public support for labeling and banning of nano-food in Singapore. Using data collected from a nationally representative survey of 1001 respondents, the findings demonstrated that attitudes toward technology, preference for natural product, science knowledge, and risk perception were found to substantially affect public support for both labeling and banning of nano-food. Conversely, attention to food safety news on traditional media and attention to nano-news on new media were only associated with public support for labeling of nano-food. Similarly, benefit perception was only significantly associated with public support for banning of nano-food. Theoretically, these findings support the growing body of literature that argues for the significant role played by predispositions, media use, science knowledge, and risk and benefit perceptions on attitude formation toward nano-food. It serves as the pioneering piece to address the aspect of banning in the field of nano-food. Practically, insights drawn from this study could aid relevant stakeholders in enlisting effecting strategies to convey the benefits of nano-food while mitigating the risk perceptions among the public.

  18. Health-related claims on food labels in Australia: understanding environmental health officers' roles and implications for policy.

    PubMed

    Condon-Paoloni, Deanne; Yeatman, Heather R; Grigonis-Deane, Elizabeth

    2015-01-01

    Health and related claims on food labels can support consumer education initiatives that encourage purchase of healthier foods. A new food Standard on Nutrition, Health and Related Claims became law in January 2013. Implementation will need careful monitoring and enforcement to ensure that claims are truthful and have meaning. The current study explored factors that may impact on environmental health officers' food labelling policy enforcement practices. The study used a mixed-methods approach, using two previously validated quantitative questionnaire instruments that provided measures of the level of control that the officers exercised over their work, as well as qualitative, semi-structured, in-depth interviews. Local government; Australia. Thirty-seven officers in three Australian states participated in semi-structured in-depth interviews, as well as completing the quantitative questionnaires. Senior and junior officers, including field officers, participated in the study. The officers reported a high level of autonomy and control of their work, but also a heavy workload, dominated by concerns for public health and food safety, with limited time for monitoring food labels. Compliance of labels with proposed health claims regulations was not considered a priority. Lipsky's theory of street-level bureaucracy was used to enhance understanding of officers' work practices. Competing priorities affect environmental health officers' monitoring and enforcement of regulations. Understanding officers' work practices and their perceptions of enforcement is important to increase effectiveness of policy implementation and hence its capacity to augment education initiatives to optimize health benefits.

  19. Safety of Single-Dose Primaquine in G6PD-Deficient and G6PD-Normal Males in Mali Without Malaria: An Open-Label, Phase 1, Dose-Adjustment Trial.

    PubMed

    Chen, Ingrid; Diawara, Halimatou; Mahamar, Almahamoudou; Sanogo, Koualy; Keita, Sekouba; Kone, Daouda; Diarra, Kalifa; Djimde, Moussa; Keita, Mohamed; Brown, Joelle; Roh, Michelle E; Hwang, Jimee; Pett, Helmi; Murphy, Maxwell; Niemi, Mikko; Greenhouse, Bryan; Bousema, Teun; Gosling, Roly; Dicko, Alassane

    2018-03-28

    The World Health Organization recommendation on the use of a single low dose of primaquine (SLD-PQ) to reduce Plasmodium falciparum malaria transmission requires more safety data. We conducted an open-label, nonrandomized, dose-adjustment trial of the safety of 3 single doses of primaquine in glucose-6-phosphate dehydrogenase (G6PD)-deficient adult males in Mali, followed by an assessment of safety in G6PD-deficient boys aged 11-17 years and those aged 5-10 years, including G6PD-normal control groups. The primary outcome was the greatest within-person percentage drop in hemoglobin concentration within 10 days after treatment. Fifty-one participants were included in analysis. G6PD-deficient adult males received 0.40, 0.45, or 0.50 mg/kg of SLD-PQ. G6PD-deficient boys received 0.40 mg/kg of SLD-PQ. There was no evidence of symptomatic hemolysis, and adverse events considered related to study drug (n = 4) were mild. The mean largest within-person percentage change in hemoglobin level between days 0 and 10 was -9.7% (95% confidence interval [CI], -13.5% to -5.90%) in G6PD-deficient adults receiving 0.50 mg/kg of SLD-PQ, -11.5% (95% CI, -16.1% to -6.96%) in G6PD-deficient boys aged 11-17 years, and -9.61% (95% CI, -7.59% to -13.9%) in G6PD-deficient boys aged 5-10 years. The lowest hemoglobin concentration at any point during the study was 92 g/L. SLD-PQ doses between 0.40 and 0.50 mg/kg were well tolerated in G6PD-deficient males in Mali. NCT02535767.

  20. Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection

    PubMed Central

    2014-01-01

    Background Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. Results The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. Conclusions We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance. PMID:24428898

  1. Long-term treatment of Cushing's disease with pasireotide: 5-year results from an open-label extension study of a Phase III trial.

    PubMed

    Petersenn, S; Salgado, L R; Schopohl, J; Portocarrero-Ortiz, L; Arnaldi, G; Lacroix, A; Scaroni, C; Ravichandran, S; Kandra, A; Biller, B M K

    2017-07-01

    Treating hypercortisolism in patients with Cushing's disease after failed surgery often requires chronic medication, underlining the need for therapies with favourable long-term efficacy and safety profiles. In a randomised, double-blind study, 162 adult patients with persistent/recurrent or de novo Cushing's disease received pasireotide. Patients with mean urinary free cortisol at/below the upper limit of normal or clinical benefit at month 12 could continue receiving pasireotide during an open-ended, open-label phase, the outcomes of which are described herein. Sixteen patients received 5 years of pasireotide treatment. Among these, median (95% confidence interval) percentage change from baseline in mean urinary free cortisol was -82.6% (-89.0, -41.9) and -81.8% (-89.8, -67.4) at months 12 and 60. Eleven patients had mean urinary free cortisol ≤ upper limit of normal at month 60. Improvements in clinical signs were sustained during long-term treatment. The safety profile of pasireotide at 5 years was similar to that reported after 12 months. Fifteen of 16 patients experienced a hyperglycaemia-related adverse event; glycated haemoglobin levels were stable between months 6 and 60. Adverse events related to hyperglycaemia, bradycardia, gallbladder/biliary tract, and liver safety were most likely to first occur by month 6; adverse event severity did not tend to worsen over time. This represents the longest prospective trial of a medical therapy for Cushing's disease to date. A subset of patients treated with pasireotide maintained biochemical and clinical improvements for 5 years, with no new safety signals emerging. These data support the use of pasireotide as an effective long-term therapy for some patients with Cushing's disease.

  2. Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection.

    PubMed

    Xu, Rong; Wang, QuanQiu

    2014-01-15

    Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance.

  3. Effect of consuming a purple-fleshed sweet potato beverage on health-related biomarkers and safety parameters in Caucasian subjects with elevated levels of blood pressure and liver function biomarkers: a 4-week, open-label, non-comparative trial

    PubMed Central

    OKI, Tomoyuki; KANO, Mitsuyoshi; WATANABE, Osamu; GOTO, Kazuhisa; BOELSMA, Esther; ISHIKAWA, Fumiyasu; SUDA, Ikuo

    2016-01-01

    An open-label study with one treatment arm was conducted to investigate changes in health-related biomarkers (blood pressure and liver enzyme activity) and the safety of 4 weeks of consuming a purple-fleshed sweet potato beverage in Caucasian subjects. Twenty healthy adults, 18–70 years of age, with a body mass index >25 kg/m2, elevated blood pressure and elevated levels of liver function biomarkers consumed two cartons of purple-fleshed sweet potato beverage (125 ml, including 117 mg anthocyanin per carton) daily for 4 weeks. Hematology, serum clinical profile, dipstick urinalysis and blood pressure were determined before consumption, at 2 and 4 weeks of consumption and after a 2-week washout period. A trend was found toward lowering systolic blood pressure during the treatment period (p=0.0590). No significant changes were found in diastolic blood pressure throughout the study period. Systolic blood pressure was significantly lower after 4 weeks of consumption compared with before consumption (p=0.0125) and was significantly higher after the 2-week washout period compared with after consumption (p=0.0496). The serum alanine aminotransferase level significantly increased over time, but aspartate aminotransferase and γ-glutamyltransferase levels stayed within the normal range of reference values. Safety parameters of the blood and urine showed no clinically relevant changes. The consumption of a purple-fleshed sweet potato beverage for 4 weeks resulted in no clinically relevant changes in safety parameters of the blood and urine and showed a trend toward lowering systolic blood pressure. PMID:27508114

  4. Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis.

    PubMed

    Ruperto, Nicolino; Lovell, Daniel J; Quartier, Pierre; Paz, Eliana; Rubio-Pérez, Nadina; Silva, Clovis A; Abud-Mendoza, Carlos; Burgos-Vargas, Ruben; Gerloni, Valeria; Melo-Gomes, Jose A; Saad-Magalhães, Claudia; Chavez-Corrales, J; Huemer, Christian; Kivitz, Alan; Blanco, Francisco J; Foeldvari, Ivan; Hofer, Michael; Horneff, Gerd; Huppertz, Hans-Iko; Job-Deslandre, Chantal; Loy, Anna; Minden, Kirsten; Punaro, Marilynn; Nunez, Alejandro Flores; Sigal, Leonard H; Block, Alan J; Nys, Marleen; Martini, Alberto; Giannini, Edward H

    2010-06-01

    We previously documented that abatacept was effective and safe in patients with juvenile idiopathic arthritis (JIA) who had not previously achieved a satisfactory clinical response with disease-modifying antirheumatic drugs or tumor necrosis factor blockade. Here, we report results from the long-term extension (LTE) phase of that study. This report describes the long-term, open-label extension phase of a double-blind, randomized, controlled withdrawal trial in 190 patients with JIA ages 6-17 years. Children were treated with 10 mg/kg abatacept administered intravenously every 4 weeks, with or without methotrexate. Efficacy results were based on data derived from the 153 patients who entered the open-label LTE phase and reflect >or=21 months (589 days) of treatment. Safety results include all available open-label data as of May 7, 2008. Of the 190 enrolled patients, 153 entered the LTE. By day 589, 90%, 88%, 75%, 57%, and 39% of patients treated with abatacept during the double-blind and LTE phases achieved responses according to the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30), Pedi 50, Pedi 70, Pedi 90, and Pedi 100 criteria for improvement, respectively. Similar response rates were observed by day 589 among patients previously treated with placebo. Among patients who had not achieved an ACR Pedi 30 response at the end of the open-label lead-in phase and who proceeded directly into the LTE, 73%, 64%, 46%, 18%, and 5% achieved ACR Pedi 30, Pedi 50, Pedi 70, Pedi 90, and Pedi 100 responses, respectively, by day 589 of the LTE. No cases of tuberculosis and no malignancies were reported during the LTE. Pneumonia developed in 3 patients, and multiple sclerosis developed in 1 patient. Abatacept provided clinically significant and durable efficacy in patients with JIA, including those who did not initially achieve an ACR Pedi 30 response during the initial 4-month open-label lead-in phase.

  5. Latanoprostene Bunod 0.024% in Subjects With Open-angle Glaucoma or Ocular Hypertension: Pooled Phase 3 Study Findings.

    PubMed

    Weinreb, Robert N; Liebmann, Jeffrey M; Martin, Keith R; Kaufman, Paul L; Vittitow, Jason L

    2018-01-01

    To compare the diurnal intraocular pressure (IOP)-lowering effect of latanoprostene bunod (LBN) 0.024% with timolol maleate 0.5% in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). Pooled analysis of two phase 3, randomized, multicenter, double-masked, parallel-group, noninferiority trials (APOLLO and LUNAR), each with open-label safety extension phases. Adults with OAG or OHT were randomized 2:1 to double-masked treatment with LBN once daily (qd) or timolol twice daily (bid) for 3 months followed by open-label LBN treatment for 3 (LUNAR) or 9 (APOLLO) months. IOP was measured at 8 AM, 12 PM, and 4 PM at week 2, week 6, and months 3, 6, 9, and 12. Of the 840 subjects randomized, 774 (LBN, n=523; timolol crossover to LBN, n=251) completed the efficacy phase, and 738 completed the safety extension phase. Mean IOP was significantly lower with LBN versus timolol at all 9 evaluation timepoints during the efficacy phase (P<0.001). A significantly greater proportion of LBN-treated subjects attained a mean IOP ≤18 mm Hg and IOP reduction ≥25% from baseline versus timolol-treated subjects (P<0.001). The IOP reduction with LBN was sustained through the safety phase; subjects crossed over from timolol to LBN experienced additional significant IOP lowering (P≤0.009). Both treatments were well tolerated, and there were no safety concerns with long-term LBN treatment. In this pooled analysis of subjects with OAG and OHT, LBN 0.024% qd provided greater IOP-lowering compared with timolol 0.5% bid and maintained lowered IOP through 12 months. LBN demonstrated a safety profile comparable to that of prostaglandin analogs.

  6. 75 FR 71133 - Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... considerations relevant to lead contamination of NLG traditional pottery, and labeling considerations for food... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0571] Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and the Use of...

  7. 16 CFR § 1404.4 - Requirements to provide performance and technical data by labeling-Notice to purchasers.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... heat. Also keep this insulation away from exhaust flues of furnaces, water heaters, space heaters, or other heat-producing devices. To be sure that insulation is kept away from light fixtures and flues, use... PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS CELLULOSE INSULATION § 1404.4...

  8. Pesticide Health and Safety Information

    Science.gov Websites

    español Pesticide Health and Safety Information Pesticides can be beneficial to society in many ways when pesticides are not used according to label directions, or when one is over-exposed to a pesticide . Examples of harm include: Mothballs may cause health problems when not used in air-tight containers as

  9. 33 CFR Appendix E to Part 273 - Preventive Safety Measures in Handling of Herbicides

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Handling of Herbicides E Appendix E to Part 273 Navigation and Navigable Waters CORPS OF ENGINEERS...—Preventive Safety Measures in Handling of Herbicides 1. Follow the label on each container before using the... accidental poisoning to the public or domestic animals. 3. Smoking is not permitted while herbicides are...

  10. 33 CFR Appendix E to Part 273 - Preventive Safety Measures in Handling of Herbicides

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Handling of Herbicides E Appendix E to Part 273 Navigation and Navigable Waters CORPS OF ENGINEERS...—Preventive Safety Measures in Handling of Herbicides 1. Follow the label on each container before using the... accidental poisoning to the public or domestic animals. 3. Smoking is not permitted while herbicides are...

  11. 33 CFR Appendix E to Part 273 - Preventive Safety Measures in Handling of Herbicides

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Handling of Herbicides E Appendix E to Part 273 Navigation and Navigable Waters CORPS OF ENGINEERS...—Preventive Safety Measures in Handling of Herbicides 1. Follow the label on each container before using the... accidental poisoning to the public or domestic animals. 3. Smoking is not permitted while herbicides are...

  12. 77 FR 3031 - The Goodyear Tire & Rubber Company, Grant of Petition for Decision of Inconsequential Noncompliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-20

    ... inconsequentiality to motor vehicle safety in this case is that there is no effect of the noncompliances on the... retread, repair and recycling industries must also be considered. Although tire construction affects the... labeling of the tire construction information will have an inconsequential effect on motor vehicle safety...

  13. [Development and validation of the Korean patient safety culture scale for nursing homes].

    PubMed

    Yoon, Sook Hee; Kim, Byungsoo; Kim, Se Young

    2013-06-01

    The purpose of this study was to develop a tool to evaluate patient safety culture in nursing homes and to test its validity and reliability. A preliminary tool was developed through interviews with focus group, content validity tests, and a pilot study. A nationwide survey was conducted from February to April, 2011, using self-report questionnaires. Participants were 982 employees in nursing homes. Data were analyzed using Cronbach's alpha, item analysis, factor analysis, and multitrait/multi-Item analysis. From the results of the analysis, 27 final items were selected from 49 items on the preliminary tool. Items with low correlation with total scale were excluded. The 4 factors sorted by factor analysis contributed 63.4% of the variance in the total scale. The factors were labeled as leadership, organizational system, working attitude, management practice. Cronbach's alpha for internal consistency was .95 and the range for the 4 factors was from .86 to .93. The results of this study indicate that the Korean Patient Safety Culture Scale has reliability and validity and is suitable for evaluation of patient safety culture in Korean nursing homes.

  14. Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada.

    PubMed

    Reid, Robert L; Fortier, Michel P; Smith, Lynne; Mirkin, Sebastian; Grubb, Gary S; Constantine, Ginger D

    2010-12-01

    The study was conducted to evaluate bleeding profile and safety of continuous oral contraceptive (OC) containing levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg. Healthy women who participated at seven Canadian sites in 1-year open-label study of LNG 90 mcg/EE 20 mcg daily were eligible for this second-year extension study. Primary end points included bleeding profile and adverse events. Seventy-nine women enrolled without interrupting pill taking; 62 (78.5%) completed. Adverse events were comparable to cyclic OC regimens, except unscheduled vaginal bleeding. Amenorrhea and absence of bleeding increased to about 80% and 90%, respectively, by Pill Pack 18. Mean (median) number of bleeding days for the last two 90-day intervals was 1.1 (0) and 0.7 (0) days, respectively. Continuous LNG 90 mcg/EE 20 mcg had a safety profile similar to low-dose cyclic OCs. Short-term safety profile remained excellent, with increasing rates of amenorrhea and decreasing incidence of unscheduled bleeding and/or spotting. Copyright © 2010 Elsevier Inc. All rights reserved.

  15. Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study.

    PubMed

    Sugimoto, Shinya; Naganuma, Makoto; Kiyohara, Hiroki; Arai, Mari; Ono, Keiko; Mori, Kiyoto; Saigusa, Keiichiro; Nanki, Kosaku; Takeshita, Kozue; Takeshita, Tatsuya; Mutaguchi, Makoto; Mizuno, Shinta; Bessho, Rieko; Nakazato, Yoshihiro; Hisamatsu, Tadakazu; Inoue, Nagamu; Ogata, Haruhiko; Iwao, Yasushi; Kanai, Takanori

    2016-01-01

    Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients. The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks. At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea. This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted. © 2016 S. Karger AG, Basel.

  16. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus.

    PubMed

    Ginzler, Ellen M; Wallace, Daniel J; Merrill, Joan T; Furie, Richard A; Stohl, William; Chatham, W Winn; Weinstein, Arthur; McKay, James D; McCune, W Joseph; Zhong, Z John; Freimuth, William W; Petri, Michelle A

    2014-02-01

    To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with active systemic lupus erythematosus (SLE) treated up to 7 years (n = 177 currently ongoing). Patients (n = 345) who completed a double-blind, placebo-controlled, 52-week study of belimumab 1, 4, or 10 mg/kg and 24-week extension of belimumab (placebo switched to 10 mg/kg; belimumab same dose or switched to 10 mg/kg) could receive belimumab 10 mg/kg in an open-label continuation study (n = 296). Disease activity was analyzed in patients with active SLE at baseline of the initial study. Biomarker and SLE medication changes were evaluated, and adverse events (AE) were monitored throughout the study. Total belimumab exposure over 7 years (double-blind and open-label periods): 1746 patient-years. SLE Responder Index (SRI) response rates at Week 52 in autoantibody-positive patients: placebo, 29%; belimumab, 46% (p < 0.05). In the continuation study, 57% of auto-antibody-positive patients had an SRI response by Year 2 and 65% by Year 7; severe flares occurred in 19% with placebo and 17% with belimumab during the first year, with the annual rate declining to 2%-9% during years 2-7. Anti-dsDNA autoantibodies in patients positive for them at baseline had a progressive decline of 40%-60% from baseline over 2-7 years with belimumab. Corticosteroid use decreased over time with ≥ 50-55% reduction in median dose during years 5-7. Serious and overall annual AE rates, including infections, were generally stable or decreased during 7-year treatment. Disease control and safety profile were maintained in patients with active SLE taking belimumab plus standard therapy for up to 7 years. [ClinicalTrials.gov numbers: NCT00071487 and NCT00583362].

  17. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study.

    PubMed

    Papp, Kim A; Krueger, James G; Feldman, Steven R; Langley, Richard G; Thaci, Diamant; Torii, Hideshi; Tyring, Stephen; Wolk, Robert; Gardner, Annie; Mebus, Charles; Tan, Huaming; Luo, Yingchun; Gupta, Pankaj; Mallbris, Lotus; Tatulych, Svitlana

    2016-05-01

    Tofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis. We sought to report longer-term tofacitinib efficacy and safety in patients with moderate to severe psoriasis. Data from 2 identical phase-III studies, Oral-treatment Psoriasis Trial Pivotal 1 and 2, were pooled with data from these patients in an ongoing open-label long-term extension study. Patients (n = 1861) were randomized 2:2:1 to tofacitinib 5 mg, 10 mg, or placebo twice daily (BID). At week 16, placebo patients were rerandomized to tofacitinib. Pivotal study participants could enroll into the long-term extension where they received tofacitinib at 10 mg BID for 3 months, after which dosing could be 5 or 10 mg BID. At week 28, the proportions of patients randomized to tofacitinib 5 and 10 mg BID achieving 75% or greater reduction in Psoriasis Area and Severity Index score from baseline were 55.6% and 68.8%, and achieving Physician Global Assessment of clear or almost clear were 54.7% and 65.9%. Efficacy was maintained in most patients through 24 months. Serious adverse events and discontinuations because of adverse events were reported in less than 11% of patients over 33 months of tofacitinib exposure. There was no dose comparison beyond week 52. Oral tofacitinib demonstrated sustained efficacy in patients with psoriasis through 2 years, with 10 mg BID providing greater efficacy than 5 mg BID. No unexpected safety findings were observed. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  18. Long-Term Safety and Efficacy of Lubiprostone in Opioid-induced Constipation in Patients with Chronic Noncancer Pain.

    PubMed

    Spierings, Egilius L H; Rauck, Richard; Brewer, Randall; Marcuard, Stefano; Vallejo, Ricardo

    2015-08-29

    Chronic opioid analgesic use often causes opioid-induced constipation (OIC). This open-label extension study evaluated the safety and efficacy of lubiprostone, a chloride channel (ClC-2) activator, for treatment of OIC in patients with chronic noncancer pain. Adults with OIC were enrolled from two 12-week, placebo-controlled, double-blind studies and received lubiprostone 24 μg twice daily for up to 9 months. OIC was defined as < 3 spontaneous bowel movements (SBMs)/week during the 2-week baseline period, of which ≥ 25% were characterized by hard to very hard stool consistency, subjectively incomplete evacuation, and/or moderate or worse straining. Inclusion criteria required consistent treatment with full opioid agonists ≥ 30 days prior to screening and throughout the study. All 439 patients who received lubiprostone were analyzed for safety and efficacy. Overall, 24.6% of patients reported treatment-related adverse events (AEs), most commonly nausea (5.0%), diarrhea (4.6%), headache (1.6%), and vomiting (1.4%). No treatment-related serious AEs were reported. Nausea and diarrhea each led to study discontinuation in 5 patients (1.1%); 2 cases each of nausea and diarrhea were rated as severe. Rescue medication usage decreased from month 1 (33.0%) to month 9 (18.6%). Mean weekly SBM frequency (1.4) was significantly increased from baseline at all months (P < 0.001, range 4.9 to 5.3). Straining, abdominal bloating, abdominal discomfort, stool consistency, constipation severity, and bowel habit regularity were significantly improved from baseline at all months (P < 0.001). Lubiprostone treatment was well tolerated and improved symptoms and signs of OIC in this 9-month, open-label study of patients with chronic noncancer pain. © 2015 World Institute of Pain.

  19. Electronic nicotine delivery systems: regulatory and safety challenges: Singapore perspective.

    PubMed

    Cheah, Nuan Ping; Chong, Norman Wee Lin; Tan, Jing; Morsed, Faridatul Akmam; Yee, Shen Kuan

    2014-03-01

    Many electronic nicotine delivery systems (ENDS) are marketed as safer tobacco alternative products or effective cessation therapies. ENDS samples were evaluated for design features, including nicotine and glycols content. This could be useful in developing a legal framework to handle ENDS. Identification of the nicotine, glycerol and propylene glycol (PPG) contents was conducted using gas chromatography mass spectrometry with quantification performed using flame ionisation techniques. Varying nicotine amounts were found in ENDS cartridges which were labelled with the same concentration. Chemicals such as PPG and glycerol were found to be present in the nicotine-containing liquid of the cartridges. ENDS varied in their contents and packaging information. Limited information was available on the contents of nicotine and other chemicals present in a variety of ENDS sampled. Based on samples tested in this study, many contain misleading information on product ingredients. The results show poor consistency between actual nicotine content analysed on ENDS cartridges and the amount labelled. These findings raise safety and efficacy concerns for current and would-be recreational users or those trying to quit smoking.

  20. Pathways to increase consumer trust in meat as a safe and wholesome food.

    PubMed

    Gellynck, Xavier; Verbeke, Wim; Vermeire, Bert

    2006-09-01

    This paper focuses on the effect of information about meat safety and wholesomeness on consumer trust based on several studies with data collected in Belgium. The research is grounded in the observation that despite the abundant rise of information through labelling, traceability systems and quality assurance schemes, the effect on consumer trust in meat as a safe and wholesome product is only limited. The overload and complexity of information on food products results in misunderstanding and misinterpretation. Functional traceability attributes such as organisational efficiency and chain monitoring are considered to be highly important but not as a basis for market segmentation. However, process traceability attributes such as origin and production method are of interest for particular market segments as a response to meat quality concerns. Quality assurance schemes and associated labels have a poor impact on consumers' perception. It is argued that the high interest of retailers in such schemes is driven by procurement management efficiency rather than safety or overall quality. Future research could concentrate on the distribution of costs and benefits associated with meat quality initiatives among the chain participants.

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