FDA to Keep Propecia on the Market With Updated Warnings

The FDA has rejected a request by a patient advocacy group to pull Merck’s male pattern hair loss oral drug Propecia (finasteride) from the market, but the agency will require updated labeling to list possible adverse reactions.

The Post-Finasteride Syndrome group filed a complaint against the FDA in September 2021, four years after submitting a citizens’ petition to the agency urging it to withdraw its approval of Propecia, or else to revise the drug’s safety information.

In the complaint, the group noted that the agency had failed to act on the petition and argued that the drug’s risks outweigh its benefits, citing potential side effects that include depression and suicidal ideation.

The agency has rejected the request to remove the drug from the market, citing insufficient evidence of a causal link between Propecia and the side effects. However, the agency will require the drug’s label information to include suicidal ideation and behavior in the adverse reactions section.