FDA Strengthens Propecia Label - Consumer Justice Foundation

FDA Strengthens Propecia Label

Written by Faith Anderson on April 13, 2012

PropeciaHair Loss Drug Found to Cause Sexual Dysfunction

The active ingredient in Merck & Co.’s Propecia is finasteride, which was originally approved by the FDA under brand name Proscar. Proscar is a treatment for enlarged prostate, and is used to reduce the risk of urinary retention or need for surgery in those patients. In 1997, the FDA additionally approved finasteride to treat male pattern baldness under the brand name Propecia. Propecia belongs to a class of drugs called 5-alpha reductase inhibitors and works by blocking a hormone called dihydrotestosterone. Finasteride has been shown to reduce the risk of prostate cancer, but the FDA updated the drug’s warning label in June 2011 to include the potential increased risk of a more serious type of prostate cancer.

Finasteride and Propecia Linked to Permanent Side Effects

In 2011, the Journal of Sexual Medicine published a Propecia side effect study which had alarming results. The study observed 71 otherwise-healthy men aged 21-46 who reported the new onset of sexual side effects associated with Propecia. Each participant experienced adverse sexual side effects that lasted for more than three months even after use of the drug was discontinued. According to researchers, 94% of men taking Propecia experienced low libido, 92% experienced decreased arousal, 92% suffered from erectile dysfunction, and 69% suffered from problems with orgasm.

The revised warning label for Propecia says some men who took the drug developed libido disorders, orgasm disorders and ejaculation disorders that persisted even after they were no longer taking the medication. The labels for both Propecia and Proscar also now include a description of reported cases of poor semen quality and male infertility that got better or normalized after patients stopped taking the drug. “The cases suggest a broader range of adverse effects than previously reported in patients taking these drugs,” the FDA concluded.

Posted Under: FDA - Food and Drug Administration
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