Abstract
There have been a number of highly publicized safety-based drug withdrawals in the United States in recent years. We conducted a review of drugs withdrawn since 1993 and examined trends in drug withdrawals. Our objective was to determine the frequency and characteristics of withdrawn drugs and trends since 1993, and to discuss the implications of the findings. We found that a mean of 1.5 drugs per year have been withdrawn since 1993, and that the number of withdrawals has not increased over time. However, some recent drug withdrawals have impacted large numbers of people. The rate of withdrawals alone is not an adequate measure of the status of drug safety in the US, and there is a serious dearth of data that can be used to examine the impact of drug withdrawals. Although drug withdrawals are an important issue to address, drug safety policies need to be developed within the broader context of drug safety and effectiveness. A comprehensive approach will be needed to address the improvement of drug safety. We propose improvements to the evidence base to increase drug safety and assess how new scientific evidence can be incorporated into drug safety efforts.
Keywords: Prescription drug withdrawals, drug safety, evidence base, policy implications, pharmacoepidemiology, drug surveillance
Current Drug Safety
Title: Drug Withdrawals in the United States: A Systematic Review of the Evidence and Analysis of Trends
Volume: 2 Issue: 3
Author(s): Amalia M. Issa, Kathryn A. Phillips, Stephanie Van Bebber, Hima G. Nidamarthy, Karen E. Lasser, Jennifer S. Haas, Brian K. Alldredge, Robert M. Wachter and David W. Bates
Affiliation:
Keywords: Prescription drug withdrawals, drug safety, evidence base, policy implications, pharmacoepidemiology, drug surveillance
Abstract: There have been a number of highly publicized safety-based drug withdrawals in the United States in recent years. We conducted a review of drugs withdrawn since 1993 and examined trends in drug withdrawals. Our objective was to determine the frequency and characteristics of withdrawn drugs and trends since 1993, and to discuss the implications of the findings. We found that a mean of 1.5 drugs per year have been withdrawn since 1993, and that the number of withdrawals has not increased over time. However, some recent drug withdrawals have impacted large numbers of people. The rate of withdrawals alone is not an adequate measure of the status of drug safety in the US, and there is a serious dearth of data that can be used to examine the impact of drug withdrawals. Although drug withdrawals are an important issue to address, drug safety policies need to be developed within the broader context of drug safety and effectiveness. A comprehensive approach will be needed to address the improvement of drug safety. We propose improvements to the evidence base to increase drug safety and assess how new scientific evidence can be incorporated into drug safety efforts.
Export Options
About this article
Cite this article as:
Issa M. Amalia, Phillips A. Kathryn, Van Bebber Stephanie, Nidamarthy G. Hima, Lasser E. Karen, Haas S. Jennifer, Alldredge K. Brian, Wachter M. Robert and Bates W. David, Drug Withdrawals in the United States: A Systematic Review of the Evidence and Analysis of Trends, Current Drug Safety 2007; 2 (3) . https://dx.doi.org/10.2174/157488607781668855
DOI https://dx.doi.org/10.2174/157488607781668855 |
Print ISSN 1574-8863 |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-3911 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
Voltage-Gated Ion Channels, New Targets in Anti-Cancer Research
Recent Patents on Anti-Cancer Drug Discovery Inhibitors of HDACs - Effective Drugs Against Cancer?
Current Cancer Drug Targets Kounis Syndrome Following Beta-Lactam Antibiotic Use: Review of Literature
Inflammation & Allergy - Drug Targets (Discontinued) Angiotensin II-Vasopressin Interactions in The Regulation of Cardiovascular Functions. Evidence for an Impaired Hormonal Sympathetic Reflex in Hypertension and Congestive Heart Failure
Endocrine, Metabolic & Immune Disorders - Drug Targets Targeting Apoptotic Pathways in Myocardial Infarction: Attenuated by Phytochemicals
Cardiovascular & Hematological Agents in Medicinal Chemistry Vasoconstrictor Therapy for Hepatorenal Syndrome in Liver Cirrhosis
Current Pharmaceutical Design Thioridazine: The Good and the Bad
Recent Patents on Anti-Infective Drug Discovery Pulmonary Hypertension: Clinical Presentation, Diagnosis, Treatment,and Dana Point World Symposium Highlights
Current Respiratory Medicine Reviews Electrocardiographic Assessment and Genetic Analysis in Neonates: a Current Topic of Discussion
Current Cardiology Reviews The Role of Myocardial Collagen Network in Hypertensive Heart Disease
Current Hypertension Reviews Subject Index to Volume 11
Current Medicinal Chemistry Antihypertensive Treatments in Patients Affected by Aortic Valve Stenosis
Current Pharmaceutical Design Recent Inventions on Receptor Tyrosine Kinase RET Modulation
Recent Patents on Biotechnology Thrombus Extraction Catheters vs. Angiojet Rheolytic Thrombectomy in Thrombotic Lesions/SV Grafts
Current Cardiology Reviews 5'-Nucleotidases, Nucleosides and their Distribution in the Brain: Pathological and Therapeutic Implications
Current Medicinal Chemistry The Cellular Electrophysiologic Effect of A New Amiodarone Like Antiarrhythmic Drug GYKI 16638 in Undiseased Human Ventricular Muscle: Comparison With Sotalol And Mexiletine
Current Medicinal Chemistry Prognostic Role of miRNAs in Coronary Artery Disease
Current Topics in Medicinal Chemistry Treatments for Obesity-Related Hypertension
Current Hypertension Reviews Ligand and Structure Based Models for the Identification of Beta 2 Adrenergic Receptor Antagonists
Current Computer-Aided Drug Design Post Cardiovascular Surgery Atrial Fibrillation. Biomarkers Determining Prognosis
Current Medicinal Chemistry