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

By Alan Mozes
HealthDay Reporter

MONDAY, Sept. 12 (HealthDay News) -- Many patients mistakenly believe that medications approved by the U.S. Food and Drug Administration are foolproof and free of harmful side effects, a new study finds.

But when informed of safety concerns about a drug, they tend to make a safer choice.

"There are important gaps in what people know about approved drugs, and a lot of misconceptions," said study co-author Dr. Steven Woloshin, co-director of the Outcomes Group at the VA Medical Center in White River Junction, Vt.

"Until they are given good information, people may be exposing themselves to drugs that may confer less benefit than they think they are getting, or more harm than they think they are being exposed to," added Woloshin, who is also with the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, N.H.

Far from a foolproof seal of safety and benefit, FDA-approved drugs often run into trouble after they show up in pharmacies and medicine cabinets, he and his colleague Dr. Lisa M. Schwartz report in the Sept. 12 issue of Archives of Internal Medicine.

One driver of this dynamic is the 1992 Prescription Drug User Fee Act (PDUFA), which now mandates that the FDA approve new drugs within 10 months of submission or face funding cuts.

Such fast-tracking can compromise safety, as noted in a study published in the New England Journal of Medicine in March 2008. That investigation revealed that drugs funneled through quickly in order to meet PDUFA deadlines were five times more likely to get taken off the market because of safety issues after winning FDA approval. Such meds are also more likely to need dosage alterations and get slapped with a black-label warning post-FDA approval.

Vioxx, for instance, was yanked from the market in 2004 when concerns arose about potential cardiac side effects six months following
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