CHICAGO (AP) – Almost one-third of new drugs approved by U.S. regulators over a decade ended up later with warnings about sometimes serious side effects.
That’s according to a new analysis published Tuesday in the Journal of the American Medical Association.
It involves all 222 prescription drugs approved by the Food and Drug Administration from 2001 to 2010. Researchers looked at potential problems that cropped up during routine monitoring that’s done once a medicine is on the market. There were safety issues with 71 drugs including top-sellers for depression, rheumatoid arthritis, infections and blood clots.
Three drugs were withdrawn and black-box warnings and less serious safety announcements were issued for dozens of other drugs.
Critics say the study raises questions about how thoroughly drugs are tested.
The FDA says it’s reviewing the results.
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