The U.S. Food and Drug Administration has announced changes to the professional labels for Propecia (finasteride 1 mg, generally prescribed for male-pattern baldness) and Proscar (finasteride 5 mg, generally prescribed for benign prostatic hyperplasia) to expand the list of sexual adverse events that have been reported.
The label changes reflect the reporting of adverse sexual events that continue in patients who have stopped using the drug. The changes include:
• A revision to the Propecia label to include libido disorders, ejaculation disorders and orgasm disorders that continued after discontinuation of the drug.
• A revision to the Proscar label to include decreased libido that continued after discontinuation of the drug.
• Revisions to both labels to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.
Clear causal links between finasteride and sexual adverse events have not been established, the FDA noted, but the reported cases suggest a broader range of adverse effects than previously reported in patients taking these drugs.
“Information about these adverse events may be important to individual patients,” the FDA wrote. “Therefore, prescribers and patients need to be aware of them as part of a discussion of risk and benefits of finasteride when determining the best treatment options.”