Food and Drug Administration

The odds of a drug having a significant safety issue after winning FDA approval are nearly 1 in 3, study finds

The odds of a drug having a significant safety issue after winning FDA approval are nearly 1 in 3, study finds

Almost one-third of new drugs approved by U.S. regulators over a decade ended up years later with warnings about unexpected — sometimes life-threatening — side effects or complications, according to a new analysis in the Journal of the American Medical Assn.

Researchers looked at potential problems that cropped up during the routine monitoring that's done once a medicine has been approved by the Food and Drug Administration and is on the market. The results, published Tuesday, covered all 222 prescription drugs approved by the FDA from 2001 through 2010.

The 71 drugs that were flagged...

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