Are certain Hair Loss drugs causing suicidal thoughts? EU drugs regulator begins review

During the review, PRAC will assess all available data linking finasteride and dutasteride to suicidal ideation and behaviours. 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.

After reviewing all available data on suicidal ideation and behaviours with finasteride and dutasteride, EMA will issue a recommendation on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU.

Tablets containing 1 mg of 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 5 mg finasteride and capsules containing 0.5 mg 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 authorised in several countries of the European Union (EU). To minimise the risks, measures are already in place for finasteride medicines, including warnings in the product information for healthcare professionals to monitor patients for psychiatric symptoms and stop treatment if symptoms occur, and recommendations for patients to seek medical advice if they experience psychiatric symptoms.

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