HQ Team
October 5, 2024: The European Medicines Agency is reviewing two medical compounds meant to treat hair loss and prostate enlargement following concerns regarding suicidal ideation and behaviours.
The oral medications containing finasteride and dutasteride, have a known risk of psychiatric side effects, including depression, according to an EMA statement.
During the review, the Pharmacovigilance Risk Assessment Committee will assess all available data linking finasteride and dutasteride to suicidal ideation and behaviours.
The review of medicines has been initiated at the French medicines agency’s (ANSM) request.
Benefit-risk balance
It will also evaluate the impact of suicidal ideation and behaviours on the benefit-risk balance of these medicines, taking into consideration the conditions they are used to treat.
Tablets containing finasteride and finasteride solution for application to the skin are used to treat the early stages of androgenic alopecia — hair loss due to male hormones — in men aged 18 to 41 years.
Finasteride tablets and capsules containing dutasteride are used to treat men with benign prostatic hyperplasia, a condition in which the prostate is enlarged and can cause problems with the flow of urine.
“Suicidal ideation has also recently been added as a possible side effect of unknown frequency in the product information for Propecia and Proscar, the first two finasteride-containing medicines authorised in several countries of the European Union.”
Propecia, Proscar
Finasteride is the main ingredient in Organon’s hair loss product Propecia, and its product for benign prostatic hyperplasia, Proscar.
Products containing Dutasteridethe medicine include GSK’s Avodart, which is approved in the US for benign prostatic hyperplasia and is sometimes used off-label to treat hair loss.
The EMA stated that measures were in place to minimise the risk for finasteride medicines, including warnings in the product information for healthcare professionals to monitor patients for psychiatric symptoms.
Steps to stop treatment if symptoms occur and recommendations for patients to seek medical advice if they experience psychiatric symptoms were also made available to the public.
