The FDA announced its decision on Thursday to update the label for Propecia, a popular hair loss drug, to reflect the risk of irreversible sexual side effects in patients, even after use of the drug is terminated. According to the FDA, patients who use Propecia to treat their male pattern baldness may suffer from sexual …
The FDA announced its decision on Thursday to update the label for Propecia, a popular hair loss drug, to reflect the risk of irreversible sexual side effects in patients, even after use of the drug is terminated. According to the FDA, patients who use Propecia to treat their male pattern baldness may suffer from sexual side effects like erectile dysfunction, decreased libido, problems with ejaculation, and orgasm disorders. Even more alarming, these side effects may persist even after the patients are no longer taking the medication. The FDA also included in the Propecia label a description of reported cases of poor semen quality and male infertility linked to Propecia that improved or normalized after patients got off the medication.
Safety Concerns for Merck & Co.’s Hair Loss Drug, Propecia
Propecia is a hair loss drug commonly used by men to treat male pattern baldness. The active ingredient in Propecia is finasteride, a drug first approved by the FDA in 1992 as Proscar, a treatment for enlarged prostate. In 1997, the FDA approved an additional indication for finasteride under the brand name Propecia, and the drug has become a popular method of treatment for male pattern baldness. Propecia belongs to a class of drugs called 5-alpha reductase inhibitors, which function by blocking the hormone dihydrotestosterone, and is currently manufactured by drug company Merck & Co.
Propecia Linked to Irreversible Sexual Dysfunction Side Effects
Prior to announcing the label change, the FDA reviewed 421 post-marketing reports of sexual dysfunction associated with Propecia that were submitted between 1998 and 2011. Of these, 59 cases reported sexual dysfunction side effects that continued for at least three months even after the use of Propecia was discontinued. According to the FDA, “the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs.” The FDA’s research isn’t the only to have examined the adverse effects of Propecia, however.
Just last year, the Journal of Sexual Medicine published a study in which researchers found that 94% of the seventy-one Propecia users observed experienced low libido, 92% suffered from decreased arousal, 92% suffered from erectile dysfunction, and 69% experienced problems with orgasm. All participants in the study reported the new onset of sexual side effects associated with Propecia that lasted for more than three months even after use of the medication was stopped. The average duration of the side effects was an alarming forty months.