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Public Often Unaware of a Drug's Safety Record -- Or Lack of One
Date:9/13/2011

to be aware that almost any drug has potential side effects," he said. "And for newly approved drugs there's often insufficient information about serious risks, some of which may have gone undetected during the approval process and won't be detected until they're used in the real-world setting on a wide-scale basis."

His organization supports a "do-not-use-for-seven-years rule," Carome said. "Unless a new drug is a breakthrough medication for a condition for which there were no previously good options, we recommend that people not take it for at least seven years."

Harvard University's Daniel Carpenter, a professor of government, said "the term 'FDA-approved' gives patients a mental and emotional security about a drug." But it's possible that people attach too much subconscious trust to this stamp of approval, he added.

"So I'm in sympathy," he continued, "with the policy recommendation that patients ought to be made aware, for example, that we know less about an FDA-approved drug that has been on the market for a day or a year than we do about drugs that have been on the market for five or 10 years."

But how to get that message across effectively in real-world practice will need a lot more research, he said.

Writing in the same journal issue, Dr. Deborah Grady, of the department of medicine at the University of California, San Francisco, recommended that the job of selecting the safer, better drug be left to properly trained clinicians.

More information

For more on the FDA drug approval process, visit the U.S. Food and Drug Administration.

SOURCES: Steven Woloshin, M.D., M.S., co-director, Outcomes Group, VA Medical Center, White River Junction, Vt., and Dartmouth Institute for Health Policy and Clinical Practice, Hanover, N.H.; Michael Carome, M.D., deputy director, Public Citizen's Health Res
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