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# Pull Propecia and Generics from Market: Foundation
- URL: https://www.fdaweb.com/pull-propecia-and-generics-from-market-foundation/
- Published: 2017-09-19T12:00:00.000Z
- Updated: 2026-09-14T22:51:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139663

The Post-Finasteride Syndrome Foundation is asking FDA to immediately withdraw marketing approval for Merck’s Propecia and generic formulations of finasteride 1 mg for androgenic alopecia “because the risk of serious injury from the drug outweighs its limited benefits.” The foundation says that an alternative request would be to immediately require amendment of “false and misleading safety information, and addition of Boxed Warnings, Warnings, Precautions, and Contraindications to the product label” for Propecia and its generic forms.

The foundation’s petition to FDA defines post-finasteride syndrome (PFS) as a heterogeneous disorder with variability in the type of symptoms experienced by different individuals with it. “PFS is a life-changing syndrome characterized by sexual dysfunction and psychoneurocognitive symptoms that first develop during Propecia use and continue indefinitely for years after the drug has been discontinued,” it says. “There are no known effective treatments and the syndrome is indiscriminate in that it develops in men without any prior medical or psychiatric history, pre-existing sexual dysfunction, or any other apparent risk factors. We estimate that tens of thousands of men worldwide who have taken Propecia or finasteride, 1 mg or 1.25 mg, for the treatment of androgenic alopecia have developed PFS.”

The petition concludes that Propecia is an unacceptably dangerous drug that can cause life-altering adverse drug reactions in individuals leading to severe permanent disability, and in rare cases death by suicide. It says that weighing the potential serious risks against the drug’s limited benefits should mandate its immediate removal from the market to protect public health. “The public health concerns regarding Propecia are especially problematic considering that Propecia is a cosmetic drug that does not treat a medical condition,” the foundation says.