Propecia Pregnancy Category X - Consumer Justice Foundation

Propecia Pregnancy Category X

Written by Faith Anderson on January 24, 2012
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Merck’s Hair Loss Drug, Propecia

Propecia (generic – finasteride) is a prescription medication used to stimulate hair regrowth in men struggling with male pattern baldness, a common condition many men face, characterized by the thinning of hair on the scalp. The active ingredient in Propecia, finasteride, was originally approved by the FDA in 1992 as Proscar, a treatment for enlarged prostate. In 1997, finasteride garnered FDA approval as Propecia, which is currently manufactured by Merck & Co. Propecia is a synthetic 5-alpha reductase inhibitor, which inhibits the enzyme that converts testosterone to dihydrotestosterone.

Propecia Side Effect Warnings and Birth Defect Risk

According to Propecia side effect warnings, the hair loss drug is not indicated for use by women and is actually known to cause birth defects in a developing male baby. Because of this danger, Propecia is classified as a pregnancy category X medication by the FDA, which means that there are proven fetal risks associated with the medication. In fact, women who are pregnant or planning to become pregnant have been warned not to even handle broken or crushed Propecia tablets, as the drug can be absorbed through the skin. At this point, it is not known whether Propecia passes into breast milk, so women who are breastfeeding are advised against taking the medication. Propecia warnings also indicate that the medication may pass into the semen of men, but a pregnant woman’s contact with the semen of a man taking Propecia does not seem to be an issue for concern at this time.

Additional Propecia Side Effect Information and Pregnancy Risks

Propecia functions by blocking the conversion of testosterone into dihydrotestosterone (DHT), thereby decreasing the amount of DHT in the body. Since DHT plays an active role in perpetuating inherited male pattern baldness, Propecia can theoretically stimulate hair regrowth in men with this condition by preventing its production. Unfortunately, because DHT is critical for male genital development, if taken during pregnancy, Propecia may cause serious abnormalities to the external genitals of a male fetus. Although most women know that Propecia has only been approved for use in men, they may not be aware that even touching or handling broken or crushed Propecia tablets can cause devastating birth defects in their children. This Propecia birth defect risk combined with the risk of permanent sexual dysfunction side effects in men suggests that the potential risks associated with Propecia treatment may significantly outweigh any possible benefits of the treatment.

Posted Under: FDA - Food and Drug Administration
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