Drug Safety for Women: New FDA Policies

-The U.S. Food and Drug Administration (FDA) has made measurable progress taking into consideration sex and gender differences in drug trial development and review of the data, and in supporting inclusion of women in clinical trials. It has also advanced comprehensive drug safety reviews and post market surveillance and risk assessment, according to a report in the peer-reviewed Journal of Women’s Health. Click here to read the article now. Click here to read the article now.

Erin South, PharmD, and coauthors from the U.S. Food and Drug Administration examined drugs withdrawn from the market for safety-related reasons from 2001-2018. They found the following: “Two major reasons for drug market withdrawal, 1) QT prolongation resulting in risk of TdP [Torsades de Pointes] or other abnormal heart rhythms and 2) drug-induced liver injury (DILI), which are known to occur more often in females than males, have not contributed to the market withdrawal of any drug approved over the past decade.”

“Policy changes put in place by the FDA “to promote drug safety for women had measurable and sustainable effects,” state Alyson McGregor, MD, Warren Alpert Medical School of Brown University and Bruce Becker, MD, Brown University School of Public Health, in an accompanying editorial. The authors’ “findings of a 67% reduction in yearly post market drug withdrawals due to unanticipated adverse drug reactions in women supports the effectiveness of the FDA’s changing policies.”

About the Journal

Journal of Women’s Health, published monthly, is a core multidisciplinary journal dedicated to the diseases and conditions that hold greater risk for or are more prevalent among women, as well as diseases that present differently in women. Led by Editor-in-Chief Susan G. Kornstein, MD, Executive Director of the Virginia Commonwealth University Institute for Women’s Health, Richmond, VA, the Journal covers the latest advances and clinical applications of new diagnostic procedures and therapeutic protocols for the prevention and management of women’s healthcare issues. Complete tables of content and a sample issue may be viewed on the Journal of Women’s Health website. Journal of Women’s Health is the official journal of the Society for Women’s Health Research.

About the Publisher

Mary Ann Liebert, Inc., publishers is known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research. A complete list of the firm’s more than 90 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.

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