Finasteride-dutasteride Article 31 referral — PRAC assessment report (EMA/PRAC/55203/2025)
European Medicines Agency, Pharmacovigilance Risk Assessment Committee (PRAC)
EMA (ema.europa.eu)2025-05
Summary (paraphrased)
The full PRAC assessment behind the 2025 EU-wide review of finasteride and dutasteride, triggered by France's ANSM over suicidal ideation. The report evaluates 325 EudraVigilance cases of suicidal ideation (313 finasteride, 13 dutasteride) against roughly 270 and 82 million patient-years of exposure. It documents a large burden of co-reported sexual adverse effects (erectile dysfunction, loss of libido, ejaculation disorders) and notes that a pattern of combined sexual and psychiatric effects persisting despite drug withdrawal appeared in 187 of the cases. The report also discusses cases in patients under 18 and the absence of an identifiable common risk factor among completed suicides.
Why it’s in the corpus
The primary technical document of the biggest EU regulatory action on finasteride to date. Its case-level discussion of sexual dysfunction persisting alongside psychiatric effects after withdrawal is directly on axis for the corpus and cites the exact case counts the corpus can quote.
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