FDA Orders New Warning Labels for Propecia and Proscar Over Male Sexual Function Damage

Baldness drug Propecia and enlarged prostate drug Proscar, both manufactured by Merck & Company, will now both carry a new warning linking the two drugs to sexual dysfunction after treatment this according to the Food and Drug Administration. The warning for Propecia will include a warning regarding libido disorders, ejaculation disorders, and orgasm disorders that continue after discontinuation of the drug. A revision to the Proscar label will include a warning about decreased libido that continues after discontinuation of the drug. Finally, a revision to both the Propecia and Proscar labels will include a description of reports of male infertility and/or poor semen quality that normalizes or improves after discontinuation of the drugs.

Proscar was approved in 1992 for treatment of in men with benign prostatic hyperplasia (also referred to as BPH or an enlarged prostate).

Propecia was approved in 1997 for the treatment of men with male pattern hair loss.

Helpful links:

FDA: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=propecia&utm_content=6

Bloomberg Article:

http://www.bloomberg.com/news/2012-04-12/merck-s-baldness-drug-linked-to-sex-concerns-after-use.html