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USDA warns two drugs for men may have sexual side effects

04-14-2012 • www.rawstory.com, By Agence France-Presse

Two Merck drugs for treating male baldness and enlarged prostate will now carry extended labels to add more possible sexual side effects, US regulators said.

The changes involve Propecia and Proscar, both of which contain the active ingredient finasteride, after patients reported additional adverse effects that were not apparent at the time of the drugs’ approval, the US Food and Drug Administration said Friday.

The new Propecia label will include “libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug,” the FDA said. Propecia is a drug to treat male baldness.

Proscar, which treats symptoms of enlarged prostate, will now have a label that adds “decreased libido that continued after discontinuation of the drug.”

In addition, both labels are being revised to “include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation,” the FDA said.

FDA spokeswoman Stephanie Yao said the drugs were previously known to cause adverse sexual events in a small number of patients, and that information was included on labels at the time of approval.