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Re-activateA rash from antibiotics. Constipation from blood-pressure drugs. An "out-of-body" feeling from decongestants. Many of us have experienced mild and transient side effects from medications. But one in six Americans who has ever taken a prescription drug has experienced a side effect that was serious enough to send him or her to the doctor or hospital, was life-threatening, or caused a significant disability or incapacity, according to a recent Consumer Reports phone survey of more than 1,000 consumers.
Collecting reports about serious side effects is an important function of the Food and Drug Administration's MedWatch system. Often a drug's full safety profile emerges only after it has been on the market awhile and taken by a large number of patients.
Seventy-two percent of the consumers we polled said they would know where to report a side effect. Among them, 79 percent would tell their doctor and 16 percent would contact a pharmacist. Only 35 percent were aware that they could also report serious side effects directly to the FDA. It's important to do this because MedWatch captures only a fraction of the cases. For example, in 2004 the FDA received about 423,000 adverse-event reports even though drug reactions accounted for nearly 700,000 emergency-room visits.
In 2007 Congress made it mandatory for print drug ads to include a toll-free number for reporting side effects. Consumers Union, publisher of this newsletter, thinks that this regulation should be expanded to include TV drug ads.You can report a serious side effect to the FDA's online Medwatch progam, or by phone at 800-332-1088.
—Ronni Sandroff, Director/Editor, Health Information
This article first appeared in the June 2008 issue of Consumer Reports On Health.
For more information, read about Consumer Union's testimony last week before the FDA, and see Adwatch—our video series on the facts behind the drug ads.
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