Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women

PDF Version Also Available for Download.

Description

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

Creation Information

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

Context

This text is part of the collection entitled: Government Accountability Office Reports and was provided by UNT Libraries Government Documents Department to Digital Library, a digital repository hosted by the UNT Libraries. More information about this text can be viewed below.

Who

People and organizations associated with either the creation of this text or its content.

Publisher

Provided By

UNT Libraries Government Documents Department

Serving as both a federal and a state depository library, the UNT Libraries Government Documents Department maintains millions of items in a variety of formats. The department is a member of the FDLP Content Partnerships Program and an Affiliated Archive of the National Archives.

Contact Us

What

Descriptive information to help identify this text. Follow the links below to find similar items on the Digital Library.

Description

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."

Subjects

Language

Item Type

Identifier

Unique identifying numbers for this text in the Digital Library or other systems.

Collections

This text is part of the following collection of related materials.

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.

What responsibilities do I have when using this text?

When

Dates and time periods associated with this text.

Creation Date

  • January 19, 2001

Added to The UNT Digital Library

  • June 12, 2014, 7:50 p.m.

Usage Statistics

When was this text last used?

Yesterday: 0
Past 30 days: 2
Total Uses: 9

Where

Geographical information about where this text originated or about its content.

Place Name

Publication Place

Map Information

  • map marker Automatically generated Place Name coordinates.
  • map marker Automatically generated Publication Place coordinates.
  • Repositioning map may be required for optimal printing.

Mapped Locations

Interact With This Text

Here are some suggestions for what to do next.

Start Reading

PDF Version Also Available for Download.

Citations, Rights, Re-Use

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.. (digital.library.unt.edu/ark:/67531/metadc297960/: accessed August 23, 2017), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Government Documents Department.