MHRA strengthens finasteride and dutasteride safety warnings
UK prescribers must discuss updated finasteride and dutasteride safety risks
Change
The UK’s MHRA updated product information for finasteride 1 mg and dutasteride 0.5 mg to strengthen warnings on psychiatric and sexual dysfunction risks and add precautionary dutasteride advice.
Why it matters
The update makes sexual dysfunction, mood disorders, depression and suicidal thoughts part of the safety discussion for finasteride treatment. Dutasteride product information now carries a precautionary warning because mood alterations have been reported with finasteride, a medicine in the same class. Existing finasteride patient alert cards remain in place, and suspected adverse reactions continue to route through the Yellow Card scheme.
Implications
- — UK prescribers using finasteride 1 mg or dutasteride 0.5 mg must discuss the updated psychiatric and sexual dysfunction safety information with patients — treatment decisions must reflect the revised MHRA product information.
- — Pharmacists and patient-safety teams handling finasteride patients must reinforce the stop-treatment and medical-advice instruction for depression or suicidal thoughts — the MHRA safety update makes this patient action explicit.
- — Product-information and pharmacovigilance teams for UK finasteride and dutasteride medicines must align patient-facing and professional materials with the updated warnings — outdated risk communication conflicts with the revised MHRA safety advice.
Who is affected
- — UK prescribers using finasteride or dutasteride
- — Pharmacists and patient-safety teams handling finasteride patients
- — Product-information and pharmacovigilance teams for finasteride and dutasteride medicines