Significant Safety Events Found in a Third of FDA-Approved Drugs, Study Finds

Posted 09 May 2017 By Zachary Brennan

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Among 222 novel therapeutics approved by the US Food and Drug Administration (FDA) from 2001 through 2010, 32% were affected by a postmarket safety event, according to a study published in JAMA on Tuesday.

Biologics, psychiatric therapeutics and those receiving accelerated approval and near–regulatory deadline approval were statistically significantly associated with higher rates of events, the study found.

Of the 222 new drugs and biologics assessed, the study found 123 new postmarket safety events (three withdrawals, 61 boxed warnings and 59 FDA safety communications) during a median follow-up period of 11.7 years. 

The authors, including Dr. Nicholas Downing of Boston’s Brigham and Women’s Hospital and Nilay Shah, PhD, of the Mayo Clinic, highlighted the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.

Downing told Focus via email: “While our analysis cannot tell us if the ‘right number’ of postmarket safety events are being identified, it does highlight the importance of studying the safety of drugs throughout their lifecycle, especially given the inherent residual uncertainty about the safety of new drugs at time of approval.”

But he also noted, “It may be possible to identify postmarket safety events sooner, thereby reducing patients’ exposure to these previously unknown safety risks. Clinical data from electronic medical records and registries, administrative claims data and postmarket clinical trials represent key sources of information about drug safety in the postmarket period. The linkage of such large datasets and the application of precision analytics seems to likely to be worthwhile.”

JAMA

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Categories: Biologics and biotechnology, Drugs, Crisis management, Compliance, Product withdrawl and retirement, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: adverse events, significant safety events, postmarket studies

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