Finasteride and Dutasteride – updated safety warnings for psychiatric side effects and sexual dysfunction

• The MHRA has identified suicidal thoughts and behaviours as a safety concern with finasteride and dutasteride, requiring additional risk minimisation measures in clinical practice.
• Psychiatric adverse effects and sexual dysfunction should be discussed with patients before initiating 5-alpha reductase inhibitors and monitored during treatment.
• Prescribers should review current patients on these medications and consider whether continued use remains appropriate given the updated safety profile.

The MHRA has reviewed the evidence for finasteride and dutasteride and the risk of suicidal thoughts and behaviours and has recommended further measures to minimise this risk.

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