Nearly one-third of drugs approved by the U.S. Food and Drug Administration (FDA) from 2001 to 2010 had subsequent safety issues leading to some type of action by the FDA, researchers from Yale University reported in a study appearing in JAMA. 

The authors reported that of 222 novel therapeutics approved in those years, 71 warranted a postmarket safety event, with three of the drugs withdrawn and the remainder requiring a black-box warning on side effects or a safety announcement about newly detected risks. The median time from approval to a postmarket event for affected drugs was 4.2 years, and such action was more common for psychiatric drugs, biologics, and drugs granted accelerated approval status. Accelerated approvals typically rely on surrogate endpoints, Kaiser Health News noted in a report on the study. The researchers had previously observed that the FDA approves drugs faster than the counterpart regulator in Europe, and many pivotal trials involve fewer than 1,000 patients with follow-up of 6 months or less. The Washington Post noted that safety problems often appear years later, after drugs are used by many more individuals. "No drug is completely safe, and during premarket evaluation, we are not going to pick up all the safety signals," lead author Joseph Ross told the Post. Learn more...

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