HEALTHDoctors key to triggering FDA's warning signalsThe agency's MedWatch program monitors the safety of drugs and medical devices and sounds the alarm when problems surface.By Susan J. Landers, AMNews staff. Nov. 17, 2003. Washington -- The Food and Drug Administration has eyes all over the country. They just happen to belong to physicians. Physicians are often the first ones to detect serious adverse reactions by their patients to prescribed drugs, medical products or dietary supplements, and the FDA would like to hear about those reactions via its MedWatch program. MedWatch also alerts physicians and others about newly revealed drug problems and, in that capacity, has taken on a role in the fight against counterfeit drugs with alerts about fake Procrit and Lipitor posted on its Web site and e-mailed to electronic subscribers last spring. About 25,000 physicians, patients and others filed reports last year with MedWatch when they suspected a medication or medical device caused a serious reaction. About 18,000 of those reports involved drugs. The rest were split among biologic products, medical devices and special nutritional products. MedWatch can help connect a report from a doctor in Tacoma, Wash., with reports from physicians in Yuma, Ariz., Tallahassee, Fla., and Portland, Maine, said Norman S. Marks, MD, the program's medical director. "Those four reports can become a signal that our safety evaluators can then explore more scientifically with epidemiological studies," he said. "Depending on the strength of the evidence, that information can become an FDA regulatory action." The FDA counts on reports from physician offices across the nation as an important part of its postmarketing surveillance for drugs and medical devices that have received the agency's imprimatur. [...]Full text of AMNews content is available to AMA members and paid subscribers.
Copyright 2003 American Medical Association. All rights reserved.
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