EMA/PRAC latest meeting highlights

The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors.

Tablets containing 1mg 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. Tablets containing 5mg finasteride and capsules containing 0.5mg dutasteride are used to treat men with benign prostatic hyperplasia (BPH), a condition in which the prostate is enlarged and can cause problems with the flow of urine.

Medicines containing finasteride and dutasteride taken by mouth have a known risk of psychiatric side effects, including depression. 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 authorized in several countries of the European Union (EU).