MHRA strengthens safety warnings for finasteride and…

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated safety advice to strengthen warnings about potential psychiatric and sexual dysfunction linked to finasteride and to provide precautionary advice on a similar product, dutasteride.

Following an additional detailed review of the evidence, including the outcome of a European regulatory review, the MHRA has published a new Drug Safety Update and is updating product information for medicines containing finasteride and dutasteride to provide clearer guidance for healthcare professionals and patients.

Finasteride is used to treat male pattern hair loss at a dose of 1mg, and benign prostatic hyperplasia at a dose of 5mg. Dutasteride (0.5mg) is used to treat benign prostatic hyperplasia.

The updates include:

• strengthened warnings in the product information for finasteride 1mg for androgenetic alopecia to clarify that sexual dysfunction may contribute to mood disorders, and that sexual dysfunction has also been reported with and without mood alterations
• a precautionary warning added to the product information for dutasteride to note that mood alterations have been reported with a medicine in the same class, finasteride

Existing UK patient alert cards for finasteride, introduced in 2024, remain in place. These cards highlight the risks of sexual dysfunction, depression and suicidal thoughts and advise patients on what action to take if side effects occur.

Dr Alison Cave, MHRA Chief Safety Officer, said: 

“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.

“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 taking finasteride who experience depression or suicidal thoughts should stop treatment and seek medical advice. Any concerns about sexual side effects should be discussed with a healthcare professional.

Suspected adverse reactions can be reported to the MHRA through the Yellow Card scheme.

Notes

• Healthcare professionals and patients can find more information in the Drug Safety Update.
• The MHRA completed a safety review into finasteride in 2024, following which strengthened warnings and patient alert cards were introduced.
• The latest updates follow consideration of a European regulatory review under Article 31 and expert advice from the Commission on Human Medicines.
• Product information updates apply to finasteride 1 mg and dutasteride 0.5 mg medicines.
• The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
• The MHRA is an executive agency of the Department of Health and Social Care.

source: GOV