Many FDA Approved Drugs Have Late, Unexpected Warnings

FILE - This Oct. 14, 2015, file photo, shows the Food & Drug Administration campus in Silver Spring, Md. The FDA is reconsidering whether doctors who prescribe painkillers like OxyContin should be required to take safety training courses, according to federal documents released Friday, April 29, 2016. (AP Photo/Andrew Harnik, File)

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, a new analysis found. The results covered all 222 prescription drugs approved by the U.S. Food and Drug Administration from 2001 through 2010. The researchers looked at potential problems that cropped up during routine monitoring that’s done once a medicine is on the market. The 71 flagged drugs 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 Dr. Joseph Ross, the study’s lead author and an associate professor of medicine and public health But Ross said the results suggest that the FDA “is kind of doing a great job” at scrutinizing drugs after approval.