Overview
- The MHRA issued a new Drug Safety Update on Monday, tightening advice after reviewing psychiatric and sexual side effects linked to finasteride.
- Product information will change, with finasteride 1mg now warning that sexual dysfunction can contribute to mood disorders, while dutasteride adds a class-precaution about mood changes reported with finasteride.
- Patients taking finasteride 1mg who develop depression or suicidal thoughts should stop the medicine and contact a clinician, and those on finasteride 5mg or dutasteride should seek medical advice quickly.
- Yellow Card reports to May 31, 2025 record 170 cases of suicidal ideation for finasteride with 19 fatal reports of suicide, compared with five non-fatal reports for dutasteride.
- Finasteride patient alert cards introduced in 2024 remain in packs, and heavy monthly prescribing of finasteride 5mg and dutasteride for prostate enlargement tops 400,000 items, which underscores the need for clear guidance and prompt side‑effect reporting.