CHICAGO (AP) -- New research estimating that 20 percent of recently approved prescription drugs have serious and even life-threatening side effects suggests doctors should prescribe older medication whenever possible.
"It's like playing Russian roulette when a doctor prescribes a newly approved drug that doesn't have a big breakthrough," said Dr. Sidney Wolfe of Public Citizen Health Research Group, a co-author of the study.
The findings, published in Wednesday's Journal of the American Medical Association, should prompt the Food and Drug Administration to consider raising its threshold for approving new drugs when safe and effective alternatives exist, the researchers said. They said pressure from pharmaceutical companies and doctors' failure to closely read warning labels are partly to blame.
An accompanying editorial by two FDA experts said the analysis overstates the problem.
Safety studies that are conducted before a drug wins approval typically involve a few thousand patients and may not detect all side effects, especially relatively rare ones, Drs. Robert Temple and Martin Himmel said.
"Frequent post-marketing label changes are therefore inevitable and should be anticipated," they wrote.
The researchers, led by Dr. Karen Lasser of Cambridge Hospital and Harvard Medical School, analyzed 548 drugs approved from 1975 through 1999. Of these, 56, or more than 10 percent, were later given a serious-side-effect warning or taken off the market for safety reasons. The number climbed to about 20 percent when the researchers took into account drugs that were approved toward the end of the period studied.
"When a drug that comes on the market has a 1-in-5 chance that it's going to have to be banned or get a black-box warning is pretty worrisome," Wolfe said.
Most troublesome new drugs do not represent any advance in treatment and are at best no better than older, safer drugs already on the market, he said.
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