Excluding Women from Drug Trials Leads to Unknown Risks, Side Effects

A study published this week by the Congressional General Accounting Office (GAO) reports that because women were not adequately included in clinical trials, women were more adversely affected by drugs that were pulled from the shelves because of severe side effects and health risks. Because of the underrepresentation of women in clinical trials, the affects of drugs on women are not known as well as the drugs’ affects on men. The GAO study is a follow up to the 1993 requirements that drug companies include more women in clinical trials and drug studies. Senator Tom Harkin (D-IA), who requested the report, said, “The [Food and Drug Administration] clearly needs to do a better job of determining how drugs affect men and women differently.”

Since 1997, 10 prescription drugs have been removed from the market; eight of the ten drugs pose a greater risk to women than men. Four of the eight drugs are riskier to women because they are more frequently prescribed to women. The other four drugs are used widely by both women and men, yet women had more adverse side effects from the drugs. “It is critical to discover sex-related variations before drugs are approved and in widespread use,” said Representative Hen Waxman (D-CA). “Women need to be certain that when they take a prescription drug, it has been found safe and effective for them.”


Associated Press Ð February 9, 2001; Reuters Ð February 9, 2001

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