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BMC Medicine Nov 2016We identified anti-obesity medications withdrawn since 1950 because of adverse drug reactions after regulatory approval, and examined the evidence used to support such... (Review)
Review
BACKGROUND
We identified anti-obesity medications withdrawn since 1950 because of adverse drug reactions after regulatory approval, and examined the evidence used to support such withdrawals, investigated the mechanisms of the adverse reactions, and explored the trends over time.
METHODS
We conducted searches in PubMed, the World Health Organization database of drugs, the websites of drug regulatory authorities, and selected full texts, and we hand searched references in retrieved documents. We included anti-obesity medications that were withdrawn between 1950 and December 2015 and assessed the levels of evidence used for making withdrawal decisions using the Oxford Centre for Evidence-Based Medicine criteria.
RESULTS
We identified 25 anti-obesity medications withdrawn between 1964 and 2009; 23 of these were centrally acting, via monoamine neurotransmitters. Case reports were cited as evidence for withdrawal in 80% of instances. Psychiatric disturbances, cardiotoxicity (mainly attributable to re-uptake inhibitors), and drug abuse or dependence (mainly attributable to neurotransmitter releasing agents) together accounted for 83% of withdrawals. Deaths were reportedly associated with seven products (28%). In almost half of the cases, the withdrawals occurred within 2 years of the first report of an adverse reaction.
CONCLUSIONS
Most of the drugs that affect monoamine neurotransmitters licensed for the treatment of obesity over the past 65 years have been withdrawn because of adverse reactions. The reasons for withdrawal raise concerns about the wisdom of using pharmacological agents that target monoamine neurotransmitters in managing obesity. Greater transparency in the assessment of harms from anti-obesity medications is therefore warranted.
Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Obesity; Product Surveillance, Postmarketing; Safety-Based Drug Withdrawals
PubMed: 27894343
DOI: 10.1186/s12916-016-0735-y -
Acta Orthopaedica Feb 2015
Topics: Bone Cements; Humans; Joint Prosthesis; Medical Device Recalls; Orthopedic Procedures; Product Surveillance, Postmarketing; Prostheses and Implants; Registries
PubMed: 25583041
DOI: 10.3109/17453674.2014.1002184 -
Pharmaceutical Research Sep 2023The goal of pharmacovigilance (PV) is to prevent adverse events (AEs) associated with drugs and vaccines. Current PV programs are of a reactive nature and rest entirely...
The goal of pharmacovigilance (PV) is to prevent adverse events (AEs) associated with drugs and vaccines. Current PV programs are of a reactive nature and rest entirely on data science, i.e., detecting and analyzing AE data from provider/patient reports, health records and even social media. The ensuing preventive actions are too late for people who have experienced AEs and often overly broad, as responses include entire product withdrawals, batch recalls, or contraindications of subpopulations. To prevent AEs in a timely and precise manner, it is necessary to go beyond data science and incorporate measurement science into PV efforts through person-level patient screening and dose-level product surveillance. Measurement-based PV may be called 'preventive pharmacovigilance', the goal of which is to identify susceptible individuals and defective doses to prevent AEs. A comprehensive PV program should contain both reactive and preventive components by integrating data science and measurement science.
Topics: Humans; Pharmacovigilance; Vaccines
PubMed: 37349651
DOI: 10.1007/s11095-023-03548-3 -
JAMA Jan 2023Most regulated medical devices enter the US market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are...
IMPORTANCE
Most regulated medical devices enter the US market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are "substantially equivalent" to 1 or more "predicate" devices (legally marketed medical devices with similar intended use). Most recalled medical devices are 510(k) devices.
OBJECTIVE
To examine the association between characteristics of predicate medical devices and recall probability for 510(k) devices.
DESIGN, SETTING, AND PARTICIPANTS
In this exploratory cross-sectional analysis of medical devices cleared by the US Food and Drug Administration (FDA) between 2003 and 2018 via the 510(k) regulatory submission pathway, linear probability models were used to examine associations between a 510(k) device's recall status and characteristics of its predicate medical devices. Public documents for the 510(k) medical devices were collected using FDA databases. A text extraction algorithm was applied to identify predicate medical devices cited in 510(k) regulatory submissions. Algorithm-derived metadata were combined with 2003-2020 FDA recall data.
EXPOSURES
Citation of predicate medical devices with certain characteristics in 510(k) regulatory submissions, including the total number of predicate medical devices cited by the applicant device, the age of the predicate medical devices, the lack of similarity of the predicate medical devices to the applicant device, and the recall status of the predicate medical devices.
MAIN OUTCOMES AND MEASURES
Class I or class II recall of a 510(k) medical device between its FDA regulatory clearance date and December 31, 2020.
RESULTS
The sample included 35 176 medical devices, of which 4007 (11.4%) were recalled. The applicant devices cited a mean of 2.6 predicate medical devices, with mean ages of 3.6 years and 7.4 years for the newest and oldest, respectively, predicate medical devices. Of the applicant devices, 93.9% cited predicate medical devices with no ongoing recalls, 4.3% cited predicate medical devices with 1 ongoing class I or class II recall, 1.0% cited predicate medical devices with 2 ongoing recalls, and 0.8% cited predicate medical devices with 3 or more ongoing recalls. Applicant devices citing predicate medical devices with 3 or more ongoing recalls were significantly associated with a 9.31-percentage-point increase (95% CI, 2.84-15.77 percentage points) in recall probability compared with devices without ongoing recalls of predicate medical devices, or an 81.2% increase in recall probability relative to the mean recall probability. A 1-SD increase in the total number of predicate medical devices cited by the applicant device was significantly associated with a 1.25-percentage-point increase (95% CI, 0.62-1.87 percentage points) in recall probability, or an 11.0% increase in recall probability relative to the mean recall probability. A 1-SD increase in the newest age of a predicate medical device was significantly associated with a 0.78-percentage-point decrease (95% CI, 1.29-0.30 percentage points) in recall probability, or a 6.8% decrease in recall probability relative to the mean recall probability.
CONCLUSIONS AND RELEVANCE
This exploratory cross-sectional study of 510(k) medical devices cleared by the FDA between 2003 and 2018 demonstrated significant associations between 510(k) submission characteristics and recalls of medical devices. Further research is needed to understand the implications of these associations.
Topics: Algorithms; Cross-Sectional Studies; Databases, Factual; Device Approval; Medical Device Recalls; United States; United States Food and Drug Administration
PubMed: 36625811
DOI: 10.1001/jama.2022.22974 -
Environmental Health Perspectives Oct 2019Per- and polyfluoroalkyl substances (PFASs) are common industrial and consumer product chemicals with widespread human exposures that have been linked to adverse health...
BACKGROUND
Per- and polyfluoroalkyl substances (PFASs) are common industrial and consumer product chemicals with widespread human exposures that have been linked to adverse health effects. PFASs are commonly detected in foods and food-contact materials (FCMs), including fast food packaging and microwave popcorn bags.
OBJECTIVES
Our goal was to investigate associations between serum PFASs and consumption of restaurant food and popcorn in a representative sample of Americans.
METHODS
We analyzed 2003-2014 serum PFAS and dietary recall data from the National Health and Nutrition Examination Survey (NHANES). We used multivariable linear regressions to investigate relationships between consumption of fast food, restaurant food, food eaten at home, and microwave popcorn and serum levels of perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), perfluorodecanoic acid (PFDA), perfluorohexanesulfonic acid (PFHxS), and perfluorooctanesulfonic acid (PFOS).
RESULTS
Calories of food eaten at home in the past 24 h had significant inverse associations with serum levels of all five PFASs; these associations were stronger in women. Consumption of meals from fast food/pizza restaurants and other restaurants was generally associated with higher serum PFAS concentrations, based on 24-h and 7-d recall, with limited statistical significance. Consumption of popcorn was associated with significantly higher serum levels of PFOA, PFNA, PFDA, and PFOS, based on 24-h and 12-month recall, up to a 63% (95% CI: 34, 99) increase in PFDA among those who ate popcorn daily over the last 12 months.
CONCLUSIONS
Associations between serum PFAS and popcorn consumption may be a consequence of PFAS migration from microwave popcorn bags. Inverse associations between serum PFAS and food eaten at home-primarily from grocery stores-is consistent with less contact between home-prepared food and FCMs, some of which contain PFASs. The potential for FCMs to contribute to PFAS exposure, coupled with concerns about toxicity and persistence, support the use of alternatives to PFASs in FCMs. https://doi.org/10.1289/EHP4092.
Topics: Alkanesulfonic Acids; Dietary Exposure; Environmental Pollutants; Feeding Behavior; Fluorocarbons; Food Packaging; Humans
PubMed: 31596611
DOI: 10.1289/EHP4092 -
Current Opinion in Nephrology and... Nov 2009Acute phosphate nephropathy (APN) has been identified in renal biopsy specimens of patients exposed to oral sodium phosphate (OSP) bowel purgatives. Biopsy confirmed... (Review)
Review
PURPOSE OF REVIEW
Acute phosphate nephropathy (APN) has been identified in renal biopsy specimens of patients exposed to oral sodium phosphate (OSP) bowel purgatives. Biopsy confirmed cases presented with bland urinary sediment, low-grade proteinuria, and varying degrees of creatinine elevation. Prospective identification of APN is difficult in that definitive diagnosis requires renal biopsy, and biopsy is rarely performed for patients with this clinical presentation.
RECENT FINDINGS
Observational studies evaluating acute kidney injury after OSP exposure using interval changes in creatinine as a surrogate for APN have reported conflicting results. Although these studies have produced estimates of disease occurrence, they have been unable to definitively quantify the overall risk of APN with OSP as compared with alternative bowel-cleansing agents.
SUMMARY
On the basis of association of APN and OSP, the US Food and Drug Administration issued a boxed warning and manufacturers have ceased production and distribution of some OSP products. As this is a temporary solution, more studies are needed to delineate the pathophysiology of this disease and to better identify the subset of the population at risk for APN.
Topics: Acute Disease; Administration, Oral; Biomarkers; Biopsy; Calcium Phosphates; Cathartics; Creatinine; Drug Labeling; Humans; Kidney; Kidney Diseases; Phosphates; Proteinuria; Risk Assessment; Safety-Based Drug Withdrawals; United States; United States Food and Drug Administration; Up-Regulation
PubMed: 19636249
DOI: 10.1097/MNH.0b013e32833096af -
JAMIA Open Oct 2019Access to safe and nutritious food is essential for good health. However, food can become unsafe due to contamination with pathogens, chemicals or toxins, or mislabeling...
OBJECTIVES
Access to safe and nutritious food is essential for good health. However, food can become unsafe due to contamination with pathogens, chemicals or toxins, or mislabeling of allergens. Illness resulting from the consumption of unsafe foods is a global health problem. Here, we develop a machine learning approach for detecting reports of unsafe food products in consumer product reviews from Amazon.com.
MATERIALS AND METHODS
We linked Amazon.com food product reviews to Food and Drug Administration (FDA) food recalls from 2012 to 2014 using text matching approaches in a PostGres relational database. We applied machine learning methods and over- and under-sampling methods to the linked data to automate the detection of reports of unsafe food products.
RESULTS
Our data consisted of 1 297 156 product reviews from Amazon.com. Only 5149 (0.4%) were linked to recalled food products. Bidirectional Encoder Representation from Transformations performed best in identifying unsafe food reviews, achieving an F1 score, precision and recall of 0.74, 0.78, and 0.71, respectively. We also identified synonyms for terms associated with FDA recalls in more than 20 000 reviews, most of which were associated with nonrecalled products. This might suggest that many more products should have been recalled or investigated.
DISCUSSION AND CONCLUSION
Challenges to improving food safety include, urbanization which has led to a longer food chain, underreporting of illness and difficulty in linking contaminated food to illness. Our approach can improve food safety by enabling early identification of unsafe foods which can lead to timely recall thereby limiting the health and economic impact on the public.
PubMed: 31984365
DOI: 10.1093/jamiaopen/ooz030 -
The Journal of Invasive Cardiology Sep 2014Each year, over 1 million percutaneous coronary interventions (PCIs) are performed in the United States. Coronary stents have been shown to reduce restenosis or abrupt...
BACKGROUND
Each year, over 1 million percutaneous coronary interventions (PCIs) are performed in the United States. Coronary stents have been shown to reduce restenosis or abrupt vessel closure and therefore have improved the success of PCI. Rarely, manufacturers recall stents due to unanticipated problems. We sought to study the extent and pattern of stent recall.
OBJECTIVE
To determine the number and rate of stent recall and safety alerts, to identify trends in the rates, and to identify the nature of stent recalls.
SOURCES
The Food and Drug Administration (FDA; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm) and Healthcare Recall Management websites (RASMAS; https://alerts.rasmas.noblis.org/rasmas/c/selectViewAlertList.do) were searched. The search terms for recall were, "coronary stent" or "stent."
STUDY PERIOD
Dates were searched between November 2002 and June 2013.
RESULTS
There were 17 coronary stent recalls involving almost 500,000 units; 12 recalls (71%) were before 2006 and 5 recalls (29%) were after. Thirteen recalls (76%) consisted of class II recalls (moderate hazard); the remaining 4 were equally split between class I (severe hazard) and class III (mild hazard; 12% each). The common reasons for recall were concerns with sterility (29%) followed by wrong labeling/packaging (23%) and impaired delivery of stent (18%). In terms of units involved with recalls, 98% (472,189/481,131) were related to wrong labeling/ packaging or misbranding, while 0.1% (542/481,131) were related to potential for broken struts or crack in inflation port hub or sterility. However, approximately 2% of units were related to the potentially lethal problem of impaired balloon inflation. Recalls involved multiple manufacturers with various stent types.
CONCLUSION
The overall incidence of coronary stent recall is low and has declined over the years. The majority of stent recalls are of moderate hazard. However, due to the possibility of serious injury, clinicians should be aware of recalls.
Topics: Equipment Failure; Humans; Incidence; Medical Device Recalls; Percutaneous Coronary Intervention; Product Packaging; Retrospective Studies; Stents; Sterilization; United States; United States Food and Drug Administration
PubMed: 25198486
DOI: No ID Found -
Nicotine & Tobacco Research : Official... Apr 2020It is unclear whether warnings on electronic cigarette (e-cigarette) advertisements required by the US Food and Drug Administration (FDA) will apply to social media.... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
It is unclear whether warnings on electronic cigarette (e-cigarette) advertisements required by the US Food and Drug Administration (FDA) will apply to social media. Given the key role of social media in marketing e-cigarettes, we seek to inform FDA decision making by exploring how warnings on various tweet content influence perceived healthiness, nicotine harm, likelihood to try e-cigarettes, and warning recall.
METHODS
In this 2 × 4 between-subjects experiment participants viewed a tweet from a fictitious e-cigarette brand. Four tweet content versions (e-cigarette product, e-cigarette use, e-cigarette in social context, unrelated content) were crossed with two warning versions (absent, present). Adult e-cigarette users (N = 994) were recruited via social media ads to complete a survey and randomized to view one of eight tweets. Multivariable regressions explored effects of tweet content and warning on perceived healthiness, perceived harm, and likelihood to try e-cigarettes, and tweet content on warning recall. Covariates were tobacco and social media use and demographics.
RESULTS
Tweets with warnings elicited more negative health perceptions of the e-cigarette brand than tweets without warnings (p < .05). Tweets featuring e-cigarette products (p < .05) or use (p < .001) elicited higher warning recall than tweets featuring unrelated content.
CONCLUSIONS
This is the first study to examine warning effects on perceptions of e-cigarette social media marketing. Warnings led to more negative e-cigarette health perceptions, but no effect on perceived nicotine harm or likelihood to try e-cigarettes. There were differences in warning recall by tweet content. Research should explore how varying warning content (text, size, placement) on tweets from e-cigarette brands influences health risk perceptions.
IMPLICATIONS
FDA's 2016 ruling requires warnings on advertisements for nicotine-containing e-cigarettes, but does not specify whether this applies to social media. This study is the first to examine how e-cigarette warnings in tweets influence perceived healthiness and harm of e-cigarettes, which is important because e-cigarette brands are voluntarily including warnings on Twitter and Instagram. Warnings influenced perceived healthiness of the e-cigarette brand, but not perceived nicotine harm or likelihood to try e-cigarettes. We also saw higher recall of warning statements for tweets featuring e-cigarettes. Findings suggest that expanding warning requirements to e-cigarette social media marketing warrants further exploration and FDA consideration.
Topics: Adult; Commerce; Electronic Nicotine Delivery Systems; Female; Humans; Male; Marketing; Nicotine; Product Labeling; Smokers; Smoking; Social Media; Surveys and Questionnaires; United States; United States Food and Drug Administration
PubMed: 30820571
DOI: 10.1093/ntr/ntz029 -
Clinical and Translational Science Jul 2020Ranitidine has been the topic of recent media reports. Current findings, confirmed by the US Food and Drug Administration, indicate that some ranitidine products contain...
Ranitidine has been the topic of recent media reports. Current findings, confirmed by the US Food and Drug Administration, indicate that some ranitidine products contain a substance that may be carcinogenic. Providers and patients require additional information on the risks of continuing therapy vs. the benefits of the medication. This article comments on what is currently known about the evolving situation of elevated N-nitrosodimethylamine levels in ranitidine and the limits of the existing information to assess best practices.
Topics: Carcinogenesis; Dimethylnitrosamine; Drug Contamination; Drug Recalls; Drug Stability; Gastroesophageal Reflux; Humans; Information Dissemination; Mass Media; Neoplasms; Ranitidine; United States; United States Food and Drug Administration
PubMed: 32107850
DOI: 10.1111/cts.12753