Drug withdrawals in the United States: a systematic review of the evidence and analysis of trends.
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 We conducted a review of drugs withdrawn since 1993 and examined trends in drug withdrawals. Our objective was to determine the frequency and characteristics of withdrawn drugs and trends since 1993, and to discuss the implications of the findings. We found that a mean of 1.5 drugs per year have been withdrawn since 1993, and that the number of withdrawals has not increased over time.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.
Issa
Amalia M
AM
Program in Personalized Medicine and Targeted Therapeutics, University of Houston, 300 Technology Building, Houston, TX 77204-4021, USA. aissa@uh.edu
Phillips
Kathryn A
KA
Van Bebber
Stephanie
S
Nidamarthy
Hima G
HG
Lasser
Karen E
KE
Haas
Jennifer S
JS
Alldredge
Brian K
BK
Wachter
Robert M
RM
Bates
David W
DW
D016907:Adverse Drug Reaction Reporting Systems; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence* / Q000639:trends; D064420:Drug-Related Side Effects and Adverse Reactions; D019317:Evidence-Based Medicine; D006801:Humans; D017891:Pharmacoepidemiology / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence