Updated Safety Warnings for Finasteride and Dutasteride
The MHRA has completed a review of finasteride and dutasteride, two commonly prescribed medications for benign prostatic hyperplasia and male-pattern hair loss, and has identified important new safety information regarding psychiatric side effects and sexual dysfunction.
Key Points
- The MHRA has reviewed evidence linking finasteride and dutasteride to suicidal thoughts and behaviours
- Updated safety warnings and risk-minimisation measures have been recommended
- Healthcare providers and patients should be aware of psychiatric symptoms as potential adverse effects
- Sexual dysfunction remains a documented risk with these medications
Affected Medications
- Finasteride (including branded products such as Propecia and Proscar)
- Dutasteride (including branded products such as Avodart)
Recommended Actions
All clinicians prescribing or managing patients on finasteride or dutasteride should:
- Review the full MHRA safety update for detailed guidance on psychiatric monitoring and patient counselling
- Ensure informed consent conversations include discussion of psychiatric risks and sexual dysfunction
- Advise patients to report any mood changes, suicidal ideation, or other concerning symptoms immediately
- Consider baseline mental health assessment where appropriate, particularly in patients with a history of psychiatric illness
Further Information
For the complete MHRA safety update, including detailed clinical guidance and pharmacovigilance data, visit the MHRA Drug Safety Update.