Public Citizen Files Lawsuit Pushing FDA to Act on Propecia

A new lawsuit filed against the FDA contends that the male pattern baldness drug Propecia (1 mg) should either be taken off the market or its prescribing information should include warnings about the risk of long-term erectile dysfunction, depression and suicide.

The consumer watchdog group Public Citizen filed the suit Sept. 8 in the U.S. District Court for the District of Columbia on behalf of the Post-Finasteride Syndrome Foundation. The complaint asks the FDA to act on a petition the foundation filed in 2017, which has gone unanswered.

The 2017 petition asked the FDA to either withdraw 1 mg oral Propecia from the market or include a Black Box warning and send out a “Dear Healthcare Provider” letter, alerting clinicians to the risks associated with the medication.

The petition included information on about a dozen men whose suicides were considered related to Propecia use and contraindications for patients with a history of sexual dysfunction and depression.