Lawsuit Seeks FDA Propecia Recall Over Risk of Depression, Erectile Dysfunction and Suicide

A group advocating for patients suffering from the side effects of Propecia has filed a lawsuit calling for the FDA to recall the hair loss drug, indicating that any benefits are outweighed by the serious health risks, including depression and suicide.

Propecia (finasteride) is a prescription medication marketed by Merck to help men restore natural hair loss that occurs with male pattern baldness.

The active pharmaceutical ingredient was originally developed by Merck as a niche treatment for enlarged prostate, and marketed as Proscar in 1992. However, it is now most widely used for treatment of male pattern baldness under the brand name Propecia, and aggressively marketed in direct-to-consumer advertisements that encourage men to contact their doctors about the prescription.

The complaint (PDF) was filed against the U.S. Food and Drug Administration by the Post-Finasteride Syndrome Foundation (PFSF) on September 8, in the U.S. District Court for the District of Columbia.

According to PFSF, it filed a citizen’s petition with the FDA in September 2017, calling on the agency to withdraw its approval of Propecia, which would trigger a nationwide recall. The group’s petition noted that if the FDA did not decide to issue a recall, it should require drug manufacturers to add boxed warnings to the drug with adequate safety warnings.

“Nearly four years have passed since PFSF filed its petition, and FDA has neither granted nor denied it,” the lawsuit states. “In this action, PFSF seeks a declaration that FDA has acted unlawfully by withholding action on PFSF’s petition and an order requiring FDA to act on the petition.”

The FDA is generally required to respond to a citizen’s petition within 150 to 180 days.

The lawsuit notes that court records indicate both Merck and the FDA knew about the increased risk of suicide linked to Propecia use as far back as 2011. However, the agency decided not to add a suicide warning to the drug’s label. Those warnings are already present on versions of the drug sold in Europe and Canada, which both recommend Propecia users stop taking the drug if they experience signs of depression.

PFSF’s petition presented evidence from Vigibase, a database that tracks adverse effects of drugs sold worldwide. The database indicated that, as of 2017, there had been 2012 cases of suicidal ideation, 31 suicide attempts and 46 cases of actual suicides linked to Propecia and Proscar use.

In addition, another study by researchers at Northwestern University determined 0.8% of men taking Propecia developed erectile dysfunction lasting more than 90 days, and one-third of those continued to suffer erectile dysfunction for more than 90 days after discontinuing the drug.

While men generally take the medication to help improve their appearance and overall quality of life, the drug maker previously faced a number of Propecia lawsuits filed by men who allege that they have been left with permanent sexual complications, such as erectile dysfunction, decreased libido, genital shrinkage and problems with cognition.

According to allegations raised in the complaints, Merck has failed to adequately warn consumers or the medical community about the link between Propecia and sexual dysfunction, which may continue long after the medication is no longer used.

Prior warning information provided by the drug maker suggested that sexual dysfunction associated with the medication was rare, and that the problems resolve after use of the medication is discontinued.

Even after many men reported experiencing permanent sexual issues after Propecia use, Merck continued to provide information suggesting that the problems were temporary until the Propecia sexual dysfunction warning label was updated in April 2012. While the warning included the risk of sexual dysfunction, it did not include warnings for suicide risks. Even then, the warning indicates sexual dysfunction resolves after Propecia treatment is ended, which the PFSF lawsuit claims is not true, as noted by the number of reports of persistent erectile dysfunction reported by users.