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GAO-01-286R 1 (2001-01-19)

handle is hein.gao/gaocrptamze0001 and id is 1 raw text is: SGAO Accountability * Integrity Reliability United States General Accounting Office Washington, DC 20548 January 19, 2001 The Honorable Tom Harkin The Honorable Olympia J. Snowe The Honorable Barbara A. Mikulski United States Senate The Honorable Henry A. Waxman House of Representatives Subject: Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women The Food and Drug Administration (FDA) approves drugs for sale in the United States based on its determination that the clinical benefits of a drug outweigh its potential health risks. To make this decision, FDA reviews supporting data collected from several thousand patients during the drug's development. Once a drug is approved for marketing and used by potentially hundreds of thousands of patients, however, the type, rate, and severity of adverse events caused by the drug can be much different than those detected during the drug's development. In some cases, FDA or drug manufacturers have acted to remove from the market drugs that have been shown to have unacceptable health risks once they were in widespread use. You requested that we identify drug products withdrawn from the market in the United States since January 1, 1997, and that we note which of the withdrawn drugs posed greater health risks for women than for men. We collected this information from publicly available sources, primarily FDA documents and research articles from the medical literature. We also consulted drug safety experts. We looked only at prescription pharmaceuticals, not at vaccines or over-the-counter medicines.' We conducted our work from December 2000 to January 2001 in accordance with generally accepted government auditing standards. 'Although not included in our sample of withdrawn drugs, ingredients are occasionally removed from nonprescription drugs because they are proven to pose serious health risks. For example, on Nov. 6, 2000, FDA took steps to remove phenylpropanolamine (PPA) from all drug products and requested that all drug companies discontinue marketing products containing PPA. PPA, which could be found in many over-the-counter (OTC) and prescription cough and cold medications and OTC weight loss products, was reported to increase the risk of hemorrhagic stroke (bleeding into the brain or tissue around the brain) in women but not in men. See W.N. Kernan and others, Phenylpropanolamine and the Risk of Hemorrhagic Stroke, New England Journal of Medicine, Vol. 343, No. 25 (2000), pp. 1826- 32. GAO-01-286R Drugs Withdrawn From Market

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