The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated safety advice for finasteride and dutasteride, strengthening warnings about potential side effects including sexual dysfunction, depression, and suicidal thoughts. The announcement was made this afternoon following a comprehensive review of evidence, which included the outcome of a European regulatory review.
Updated Guidance for Patients and Healthcare Professionals
The new Drug Safety Update aims to provide clearer guidance for both healthcare professionals and patients. Finasteride is prescribed at a dose of 1mg for male pattern hair loss and at 5mg for benign prostatic hyperplasia. Dutasteride (0.5mg) is used to treat benign prostatic hyperplasia.
Key Changes to Product Information
- Strengthened warnings for finasteride 1mg to clarify that sexual dysfunction may contribute to mood disorders, and that sexual dysfunction has been reported both with and without mood alterations.
- A precautionary warning added to dutasteride product information noting that mood alterations have been reported with a medicine in the same class, finasteride.
Dr Alison Cave, MHRA Chief Safety Officer, stated: “The MHRA has taken significant action to raise awareness of the risks of sexual dysfunction, depression and suicidal thoughts associated with finasteride, including issuing a Drug Safety Update and introducing patient alert cards in 2024.”
She added: “Following an additional detailed review of the evidence, we have now strengthened product information for both finasteride 1mg and dutasteride to provide clearer guidance on these potential risks and to support informed discussions between healthcare professionals and patients.”
“Patient safety is our top priority. We expect prescribers to discuss the relevant safety information with patients so they can make informed decisions about their treatment, and we continue to encourage patients and healthcare professionals to report suspected side effects through the Yellow Card scheme.”
Patients currently taking finasteride who experience depression or suicidal thoughts are advised to stop treatment and seek medical advice immediately. Any concerns about sexual side effects should be discussed with a healthcare professional. Suspected adverse reactions can be reported to the MHRA via the Yellow Card scheme.
