FDA Warn Proscar and Propecia Labels Potential Side Effects. Men who use Propecia (finasteride 1 mg) and Proscar (finasteride 5mg) are being warned today that the drugs can cause a variety of male sexual side effects, including some that may persist after use of the drugs have been discontinued.
According to the U.S. Food & Drug Administration (FDA), the labels for both Proscar and Propecia are being updated to include new warnings about these potentially long-lasting sexual side effects, including libido disorders, ejaculation disorders, and orgasm disorders.
According to the FDA, the label for Propecia will now warn that problems with libido, ejaculation and orgasm may continue after the drug is discontinued. A warning will be added to the Proscar label regarding decreased libido that may also persist once use of the drug is stopped. The labels for both medications will also be updated to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.
The FDA decided to update the Proscar and Propecia labels after 421 postmarketing reports
The FDA decided to update the Proscar and Propecia labels after 421 postmarketing reports of sexual dysfunction among Propecia users between 1998 and 2011, 59 of which reported that the side effects lasted for at least three months after they stopped taking the drug. The agency also said it reviewed 131 cases of erectile dysfunction and 68 cases of lowered libido reported by users of Proscar.
The FDA maintains that both Proscar and Propecia are still safe drugs, asserting that only a small number of men who use the medications will experience sexual side effects.
Both Proscar and Propecia are marketed by Merck & Co. Propecia is approved to treat male pattern baldness, while Proscar is prescribed to men with enlarged prostate.