A review of drugs approved by the Food and Drug Administration (FDA) between 2001 and 2010 found that nearly a third were involved in a postmarket safety event during a median follow-up of 11.7 years.

The researchers identified 222 novel therapeutics approved during the study period (2001–2010): 183 pharmaceuticals and 39 biologics. Seventy-one (32%) of the novel therapeutics were involved in the 123 safety events that occurred during the time period: 3 withdrawals, 61 boxed warnings, and 50 safety communications.

“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,” said Nicholas Downing, MD, of Brigham and Women’s Hospital and lead author of the study. 

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Analysis showed that safety events were significantly more frequent among biologics (incidence rate ratio [IIR] = 1.93; 95% CI, 1.06–3.52; P=0.03) and psychiatric disease treatments (IRR = 3.78; 95% CI, 1.77–8.06; P<0.001), as well as treatments with accelerated approval (IRR = 2.20; 95%CI, 1.15–4.21; P=0.02), or near–regulatory deadline approval (IRR = 1.90; 95%CI, 1.19–3.05;P=0.008).

“This analysis highlights that there is residual uncertainty about the risks and benefits of new drugs at the time of approval,” said Dr. Downing. “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.”

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