Trends in Boxed Warnings and Withdrawals for Novel Therapeutic Drugs, 1996 Through 2012 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Source: JAMA Internal Medicine


Our study demonstrates that boxed warnings are common, affecting more than one-third of recent drug approvals. While nearly three-quarters of boxed warnings had been applied to novel therapeutics at the time of approval, more than 40% acquired the warning after a median market period of 4 years. Not surprisingly, the frequency of boxed warnings increased in the post-2004 period, which coincided with the aftermath of the rofecoxib (Vioxx, Merck) withdrawal and subsequent launch of FDA initiatives to strengthen drug safety surveillance, particularly postmarket reporting. Our finding that half of biological products had boxed warnings is consistent with literature suggesting that biological products pose greater risks of serious adverse events compared with other drug types. It should be noted, however, that our study was limited in sample size and excluded biological products under jurisdiction of the Center for Biologics Research and Evaluation. Furthermore, our study included only CDER-regulated drugs and therefore was not a comprehensive review of all drugs approved since 1996. Clinicians should be aware of the prevalence and growing numbers of boxed warnings and the importance of continued adverse event reporting for identifying new safety concerns.