FDA Approved Drugs Have Nearly 1 In 3 Chance Of Having A “Significant Safety Issue”

(Los Angeles Times) 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 included top sellers for treating depression, arthritis, infections and blood clots. Safety issues included risks for serious skin reactions, liver damage, cancer and even death.

“The large percentage of problems was a surprise,” and they included side effects not seen during the review process, said senior author Dr. Joseph Ross, an associate professor of medicine and public health at Yale University.

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