Risks Related to the Use of Finasteride (Propecia) in Pregnant Women

to the editor: In the Clinical Evidence Handbook on polycystic ovary syndrome (PCOS), the author discusses the off-label use of finasteride (Propecia) to reduce hirsutism in patients with PCOS. It should be emphasized that finasteride is not indicated for use in women, and is classified by the U.S. Food and Drug Administration as pregnancy risk Category X. According to the finasteride product information: “Abnormalities of external male genitalia were reported in animal studies. Pregnant women are advised to avoid contact with crushed or broken tablets.”¹ Many patients with PCOS suffer from infertility; however, many of these patients regain fertility as a result of their medical treatments. Women who choose to take finasteride for hirsutism related to PCOS should be informed of the potential risks associated with this treatment and take precautions to prevent an unplanned pregnancy.

In reply: Thanks to Dr. Keller for his recent letter regarding the safety of finasteride (Propecia), and particularly the lack of specific reference to the risks of taking an antiandrogen medication in women at risk of pregnancy, and the concomitant risks to a male fetus. Dr. Keller is, of course, correct. The prescription of finasteride to women of child-bearing age should be accompanied by counseling on the use of effective contraceptive methods.