The Medicines and Healthcare products Regulatory Agency (MHRA) has strengthened its warnings about potential psychiatric and sexual dysfunction linked to finasteride, and to provide precautionary advice on dutasteride.
Finasteride is used to treat male pattern hair loss at a dose of 1mg, and benign prostatic hyperplasia at a dose of 5mg, while Dutasteride (0.5mg) is used to treat benign prostatic hyperplasia.
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.
Following a detailed review of the evidence, including the outcome of a European regulatory review, the MHRA has published a new Drug Safety Update.
The regulator is also updating product information for medicines containing finasteride and dutasteride to provide clearer guidance for healthcare professionals and patients.
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 was added to the product information for dutasteride, noting that mood changes have been reported with a medicine in the same class, finasteride.
