Finasteride- and dutasteride-containing medicinal products — referral
European Medicines Agency (EMA)
EMA (ema.europa.eu)2025-06-19
Summary (paraphrased)
EMA's public announcement that the CMDh endorsed PRAC's Article 31 referral outcome on finasteride and dutasteride. Suicidal ideation was confirmed as a side effect of finasteride 1 mg and 5 mg tablets, with frequency unknown. The announcement states that product information for finasteride 1 mg will warn patients to seek medical advice for sexual function problems such as decreased sex drive or erectile dysfunction, which are known side effects and may contribute to mood changes, and that a patient card will be added to 1 mg packs. Dutasteride gets precautionary class-effect wording on mood changes despite insufficient evidence of a direct link.
Why it’s in the corpus
The citable public face of the 2025 EU action: explicit regulatory text linking sexual dysfunction to mood changes on finasteride, plus the patient-card measure. High-value for any timeline of regulatory responses.
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