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Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women

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Correspondence issued by the General Accounting Office with an abstract that begins "The Food and Drug Administration (FDA) approves drugs for sale in the United States when it determines 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 thousands of patients, however, the type, rate, and severity of adverse events caused by the drug can be much different than those seen during the drug's development. In some cases, FDA … continued below

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United States. General Accounting Office. January 19, 2001.

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This text is part of the collection entitled: Government Accountability Office Reports and was provided by the UNT Libraries Government Documents Department to the UNT Digital Library, a digital repository hosted by the UNT Libraries. It has been viewed 776 times, with 22 in the last month. More information about this text can be viewed below.

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Correspondence issued by the General Accounting Office with an abstract that begins "The Food and Drug Administration (FDA) approves drugs for sale in the United States when it determines 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 thousands of patients, however, the type, rate, and severity of adverse events caused by the drug can be much different than those seen during the drug's development. In some cases, FDA or drug manufacturers have removed from the market drugs that have been shown to have unacceptable health risks once they were in widespread use. GAO found that 10 prescription drugs have been withdrawn from the U.S. market since January 1, 1997. Eight of the 10 prescription drugs posed greater health risks for women than for men: four of these may have led to more adverse events in women because they were prescribed more often to women than to men, while the other four had more adverse events in women even though they were widely prescribed to both men and women. Of the two remaining withdrawn drugs, one belongs to a class of drugs known to pose a greater health risk for women, but GAO was unable to find direct evidence that the adverse events that contributed to its withdrawal occurred predominantly in women. GAO found no evidence that the health risks for the remaining withdrawn drug differed for women and men."

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Government Accountability Office Reports

The U.S. Government Accountability Office (GAO) is an independent, nonpartisan agency that works for the U.S. Congress investigating how the federal government spends taxpayers' money. Its goal is to increase accountability and improve the performance of the federal government. The Government Accountability Office Reports Collection consists of over 13,000 documents on a variety of topics ranging from fiscal issues to international affairs.

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  • January 19, 2001

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  • June 12, 2014, 7:50 p.m.

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United States. General Accounting Office. Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women, text, January 19, 2001; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc297960/: accessed December 11, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.

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