Long-term Sexual Dysfunction Warning Added to Propecia, Proscar

New label changes to Propecia, Merck’s hair loss drug, and its predecessor Proscar, will warn men about the risk that sexual side effects caused by the medications may be permanent, continuing even after the medication is no longer used. 

The label update was announced this week by the FDA, and has been long called for by health experts and Propecia sexual side effects lawyers, who have criticized the fact that Merck had stronger warnings on Propecia labels in other countries than the medication carried in the United States.

Propecia (finasteride) is approved for the treatment of male pattern baldness. It is a low-dose version of Proscar, approved in 1992 for the treatment of benign prostatic hyperplasia.

The label changes will report that Propecia has been linked to libido disorders, ejaculation disorders and orgasm disorders that may continue after discontinuation of the drug. The Proscar label will mention that it has been linked to decreased libido that continued after use of the drug has ceased. Both drugs will also include reports of sexual dysfunctions that improved after men stopped using them.

The FDA noted that the cases it has reviewed suggest a “broader range of adverse effects than previously reported in patients taking these drugs.” However, the agency also pointed out that a causal link between Propecia and erectile dysfunction or other sexual side effects has not been established.

The FDA reviewed 421 reported cases of sexual dysfunction that were sent in to the agency’s Adverse Events Reporting System between 1998 and 2011. There were 59 cases where men experienced long-term sexual dysfunction side effects for three months or longer after they stopped taking Propecia. There were 131 cases of erectile dysfunction and 68 cases of decreased libido linked to Proscar between 1998 and 2010. These adverse events likely only represent a small fraction of the total number of sexual problems experienced from Propecia and Proscar, as most men may be hesitant to speak with their doctors about the dysfunction.

Prior to this most recent label change, warnings provided to consumers and the medical community in the United States suggested that reports of erectile dysfunction and other sexual problems that may occur with Propecia were temporary and resolve after men stop taking the drug. However, the drug carries stronger warnings in a number of other countries, providing information about reports of persistent erectile dysfunction.

A number of men throughout the United States are currently pursuing a Propecia lawsuit against Merck for failing to adequately warn about the risks associated with the medication. Many plaintiffs allege that if they had been provided with accurate information about the risk of long-term sexual dysfunction, they never would have taken the prescription drug to help restore hair loss and improve their appearance.

On March 29, the U.S. Judicial Panel on Multidistrict Litigation heard arguments over whether the Propecia litigation should be consolidated before one judge for pretrial proceedings.  Dozens of lawsuits have already been filed, and some expect that hundreds of additional complaints will be brought in the coming year by otherwise health young men have experience sexual dysfunction and damage to their quality of life.