EMA To Review Finasteride and Dutasteride Over Concerns of Suicidal Thoughts

The European Medicines Agency (EMA) has initiated a review of finasteride and dutasteride due to concerns about suicidal ideation (suicidal thoughts) and behaviors. In Europe, medicines containing finasteride and dutasteride are marketed under various trade names such as Propecia (Organon), Proscar (Organon), and Avodart (GSK). Finasteride is available in 1 mg tablets and as a solution for application to the skin, used to treat androgenic alopecia (hair loss due to male hormones) and benign prostatic hyperplasia (BPH). BPH is a condition where the prostate is enlarged, causing urinary flow problems.

In the US, Organon’s Propecia is approved for male pattern hair loss, and Proscar is approved for BPH. Several generics of finasteride are also available from Dr. Reddy’s, Cipla, Aurobindo, Hetero and others. Dutasteride is approved for BPH but is often used off-label to treat hair loss. Several approved generics of dutasteride are available from Zydus, Strides, Aurobindo and others.

Finasteride and dutasteride share a similar mechanism of action. They work by preventing the enzyme 5-alpha reductase (5-AR), from converting the male hormone testosterone into 5-alpha-dihydrotestosterone (DHT). DHT is involved in hair loss and enlargement of the prostate. By inhibiting this enzyme, these medications slow hair loss, stimulate hair growth, and reduce prostate size. Psychiatric side effects are a known risk of both finasteride and dutasteride. As per an EMA notification, the agency will now review all available data on suicidal ideation and behaviours with finasteride and dutasteride and issue a recommendation on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU.

The review of medicines containing finasteride and dutasteride was initiated at the request of the French medicines agency (ANSM). The review is being conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), which is responsible for evaluating safety issues for human medicines. PRAC’s recommendations will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position on the benefit-risk balance of these medicines.

EMA: Finasteride- and dutasteride-containing medicinal products – referral