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)2022-06-08
Summary (paraphrased)
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 2011; post-discontinuation erectile dysfunction 2011/2012; infertility/seminal-quality language 2012; Proscar update 2013), declines to find the evidence sufficient to establish causality between finasteride and persistent sexual problems, depression, or suicide, but requires "suicidal ideation and behavior" to be added to the adverse reactions of all finasteride 1 mg products — the labelling win that came out of the petition. It also explains why no boxed warning, REMS, or market withdrawal was ordered.
Why it’s in the corpus
The definitive US regulatory document on finasteride safety: it is both the ruling on the patient-led petition and the complete official history of every FDA finasteride label change, with citations to the approval packages. Pairs with LIT-E-009.
Related records
- Gray literature
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)
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Mining US FDA adverse-event reports (1998–2013) for men aged 18–45 on low-dose (1 mg) finasteride, the authors applied disproportionality analysis to detect signals for persistent sexual dysfunction and suicidal ideation. Of 4,910 reports, 577 described…
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