Nearly a third of all drugs approved in the last decade by the U.S. Food and Drug Administration subsequently had "postmarket safety events," which included boxed warnings, safety communications and/or withdrawal of the products, according to a study by researchers at the Yale School of Medicine published on the American Medical Association's JAMA Network.
Among 222 "novel therapeutics" approved by the FDA from 2001 through 2010, 32 percent were affected by a postmarket safety event, according to the study. Biologics, psychiatric therapeutics, and accelerated and near–regulatory deadline approval were statistically significantly associated with higher rates of events.
"Postmarket safety events are common after FDA approval, highlighting the importance of continuous monitoring of the safety of novel therapeutics throughout their life cycle," the authors wrote.
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Katie Kuehner-Hebert
Katie Kuehner-Hebert is a freelance writer based in Running Springs, Calif. She has more than three decades of journalism experience, with particular expertise in employee benefits and other human resource topics.
