Withdrawn drugs more dangerous to women

April 1, 2001

Pharmaceutical Representative

A General Accounting Office examination of prescription drugs withdrawn from the U.S. market determined that most posed more health risks to women than to men. According to the GAO, ten prescription drugs have been withdrawn since January 1997, eight of which caused more adverse events in women; four of the drugs' users were mostly women, and four were widely prescribed to both men and women.

A General Accounting Office examination of prescription drugs withdrawn from the U.S. market determined that most posed more health risks to women than to men. According to the GAO, ten prescription drugs have been withdrawn since January 1997, eight of which caused more adverse events in women; four of the drugs' users were mostly women, and four were widely prescribed to both men and women.

"This report should encourage both the [Food and Drug Administration] and the pharmaceutical industry to continue monitoring the manner in which clinical trials are conducted, and incorporate the investigation of sex differences into every aspect of health research and care," said Phyllis Greenberger, president of the Washington-based Society for Women's Health Research.

The GAO's findings concur with the society's encouragement of research on sex differences in safety and efficacy studies, and also in earlier phases of research. Numerous differences in the incidence, manifestation and treatment of disease and health problems have been uncovered in the last decade. According to the SWHR, biologic sex can be a crucial factor in influencing response to drugs, and analysis of response by sex must be a critical part of all phases of drug research and development.

Said Raymond Woosley, associate dean for clinical research at Georgetown University Medical Center, "The conclusions reached in the GAO analysis of recent drug withdrawals verify the important role of biologic sex as a powerful predictor of the toxicity of four of the ten drugs they studied." PR