One in Three Drugs Raise Safety Concerns After FDA Approval

Drugs approved by the FDA for treatment were often found to have safety concerns, finds a research team from the Department of Medicine at Brigham and Women’s Hospital.

The research team found that nearly one in three drugs approved between 2001 and 2010 were found to have a postmarket safety event. This also included drugs which were withdrawn from the market due to safety issues.

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‘One in three drugs approved by the FDA were found to raise safety concerns.’

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Of the 222 novel therapeutics which were approved by the FDA during the time period, three of them were withdrawn, and around 61 received boxed warnings and 59 received safety communications.

The research findings were published in the journal JAMA.

"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 Downing, lead author of the study. "However, these safety risks emerge, on average, four years after approval. This means that many patients are exposed to these medications before the risks become clear."

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The team found that three drugs had been withdrawn from the market over an average follow-up period of 11.7 years. Boxed warnings, which are issued when new, life-threatening risks are identified, were issued for 61 drugs, including antipsychotics, SSRIs (selective serotonin reuptake inhibitors) and a class of drugs for the treatment of autoimmune disease. Safety communications, which are issued when new, serious risks are identified, were issued for 59 drugs, including drugs for migraine, erectile dysfunction and diabetes.

Postmarket safety events were significantly more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval and those with near-regulatory deadline approval. Events were significantly less frequent among drugs with regulatory review times less than 200 days.

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"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," said Downing.

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Source-Eurekalert