About a third of FDA-approved drugs go on to have major safety issuesEnlarge (credit: Victor)
About a third of the drugs that the Food and Drug Administration deems safe and effective go on to have major safety issues years after their approval, researchers report in JAMA.
The finding lands amid pressure from lawmakers and the Trump Administration to hasten the already fast-pace of the agency’s drug reviews.
Among 222 novel therapeutics approved by the agency between 2001 and 2010, 71 (or 32 percent) had safety events arise a median of 4.2 years later.
Safety events assessed in the study were marked by any of three FDA actions: withdrawing a drug entirely from the market; adding a boxed warning to a drug’s label, which is often added for life-threatening health risks; or issuing a safety communication, which is for serious, but non-life-threatening health risks.
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