Safety Concerns Arise in Thirty-Two Percent of Drugs After Receiving FDA Approval


Findings highlight the need for continuous safety monitoring of novel therapeutics.

Postmarket safety events occurred in 1 of 3 FDA-approved drugs between 2001 and 2010, according to a study published in JAMA.

The investigators sought to characterize the frequency of postmarket safety events among novel therapeutics approved by the FDA, and to examine whether any novel therapeutic characteristics known at the time of approval were associated with an increased safety risk.

Postmarket safety events were defined as a withdrawal from the market due to safety concerns, a boxed warning, or an FDA issuance of a safety communication.

Of the 222 novel therapeutic drugs approved between 2001 and 2010, three were withdrawn from the market over an average follow-up of 11.7 years, 61 drugs received boxed warnings, and 59 were issued safety communications.

“The fact that so many new safety risks are being identified after FDA approval indicates that the FDA is taking its responsibility of ensuring the safety of new drugs throughout their lifetime seriously,” said lead author Nicholas Downing, MD. “However, these safety risks emerge, on average, 4 years after approval. This means that many patients are exposed to these medications before the risks become clear.”

Overall, postmarket safety events were significantly more frequent among biologics, psychiatric therapeutics, drugs that received accelerated approval, and those with near-regulatory deadline approval.

Drugs with regulatory review times less than 200 days had significantly less frequent safety events.

“This analysis highlights that there is residual uncertainty about the risks and benefits of new drugs at the time of approval, thereby demonstrating the need for all stakeholders engaged in the drug development process to commit to the generation of clinically useful information both before and after regulatory approval,” Downing said.

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