Finasteride, dutasteride – New measures to minimise the risk of suicidal ideation (Direct Healthcare Professional Communication)
Marketing authorisation holders, in agreement with EMA and the Health Products Regulatory Authority (HPRA, Ireland)
HPRA (assets.hpra.ie)2025-09-12
Summary (paraphrased)
The Irish implementation letter sent to health professionals following the 2025 EU referral. It states that suicidal ideation is an adverse reaction of oral finasteride, seen mainly in men treated for androgenetic alopecia, and asks doctors to advise such patients to stop and seek help if mood symptoms appear. It explicitly flags that sexual dysfunction which may contribute to mood alterations, including suicidal ideation, has been reported in some alopecia patients, and instructs prescribers to counsel patients about sexual dysfunction and consider discontinuation. A patient card for finasteride 1 mg packs is announced, and precautionary class-effect wording is added for dutasteride.
Why it’s in the corpus
Shows how the EU Article 31 outcome translated into national prescriber-level communications — a distinct, citable document type (DHPC) for the corpus's regulatory set, with the sexual-dysfunction-to-mood pathway stated in prescriber instructions.
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