Citizen Petition to the FDA regarding Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) safety labelling
Post-Finasteride Syndrome Foundation (PFS Foundation)
PFS Foundation — FDA docket FDA-2017-P-5787 (mirror at georgesdebled.org)2017-09-18
Summary (paraphrased)
The patient advocacy group's formal petition asking FDA to withdraw approval of Propecia 1 mg for hair loss, or alternatively to overhaul its labelling. The petition requests boxed warnings for persistent erectile dysfunction, depression and suicidal ideation said to continue for years after discontinuation, contraindications for patients with sexual dysfunction or depression, a REMS, and rewritten mechanism-of-action and clinical-trial sections. Its statement of grounds argues that post-finasteride syndrome is a life-changing condition of sexual and psychoneurocognitive symptoms beginning on the drug and continuing after stopping, and lays out claims about 5-alpha-reductase inhibition affecting neurosteroid pathways beyond androgen metabolism.
Why it’s in the corpus
The patient-org filing that forced the 2022 FDA ruling (LIT-E-008); its "statement of grounds" is the most detailed single statement of the PFS case from the advocacy side, and it directly caused the suicidal-ideation label addition.
Related records
- Regulatory document
Re: Docket No. FDA-2017-P-5787 — Response to the Post-Finasteride Syndrome Foundation citizen petition
U.S. Food and Drug Administration (FDA) · FDA (letter to PFS Foundation, hosted as PDF on citizen.org)
FDA's 2022 decision letter on the PFS Foundation's 2017 citizen petition asking for withdrawal of Propecia 1 mg or stronger labelling. The agency denied the petition in part and granted it in part. It recounts the 2010–2012 labelling history (depression added…
LIT-0722022-06-08PFSLiterature sweep · Oct 2026 - Video
C-SPAN recorded the opening panel of the MAHA Institute's Mental Health and Overmedicalization Summit in Washington, DC (May 2026), where four young adults described harms they attribute to psychiatric drugs taken from childhood or adolescence. Cooper Davis…
CUR-0012026-05PSSDCurator additions - Peer-reviewed paper
Post-finasteride syndrome: a surmountable challenge for clinicians
Traish, Abdulmaged M. · Fertility and Sterility · 113(1):21-50
Systematic evaluation of 250+ articles (1989–2019) on finasteride/dutasteride concludes PFS is a real constellation of persistent sexual, neurological, physical and mental effects in a susceptible subset, proposing endocrine disruption plus epigenetic…
PFS-0012020PFSCore corpus