Approximately 32% of drugs approved by the US Food and Drug Administration (FDA) have a newly detected safety issue within 3 years following approval according to a recent study published in the Journal of the American Medical Association (JAMA).

The researchers analyzed drugs approved between 2001 and 2010 with a follow-up period through 2017. Safety issues were detected after approval for 71 of the 222 novel therapeutic drugs approved in that period. Notably, none of the safety issues resulted in drug withdrawal from the market. The safety issues were, “more commonly a black box warning, or drug safety communication issued by the FDA to let physicians and patients know that new safety information has been determined,” explained Joseph Ross, MD, lead researcher and associate professor of medicine and public health.

The researchers noted that biologics, therapeutics to treat psychiatric diseases, drugs near regulatory deadline approval, and drugs approved through the FDA’s accelerated approval pathway were more likely to be flagged for safety concerns after approval. The study draws attention to the recent push for the FDA to accelerate the drug approval process. “It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up,” explained Dr Ross.

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Current FDA approval is dependent on drug testing and clinical trials, which may include fewer than 1000 people over the course of just 6 months or less. Safety issues, which may have eluded the process, are brought to light with higher numbers of participants over longer periods of time.

“The fact that the FDA is issuing safety communications means it is doing a good job of following newly approved drugs and evaluating their safety up in the post-market period,” said Dr Ross, highlighting that the current process of continual monitoring of recently approved drugs is working.


1. Downing NS, Shah ND, Aminawung JA, et al. Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. JAMA. 2017;317(18):1854-1863.