European Medicines Agency Investigates Potential Link Between Hair Loss Drugs and Suicidal Thoughts

EMA Review Initiated:
The European Medicines Agency (EMA) has started a review of finasteride and dutasteride, drugs used to treat male balding and enlarged prostate, due to concerns over their potential link to suicidal thoughts and behaviors.

Regulatory Background:
The review was prompted by the French medicines agency, which cited new safety reports that alter the risk profile of finasteride. The EMA will assess all available data to determine if the authorizations for these drugs should be maintained, changed, suspended, or withdrawn in the European Union.

Known Risks:
Finasteride and dutasteride are known to have psychiatric side effects, including depression. Suicidal ideation has already been added as a possible side effect in the product information for Propecia and Proscar, which contain finasteride.

Previous Concerns:
This is not the first time concerns have been raised about the psychiatric symptoms of these drugs. In June 2022, the US FDA ordered a warning about suicidal thoughts and behaviors on the drug labels but declined to remove Propecia from the market.

Patient Awareness:
The UK’s Medicines and Healthcare products Regulatory Agency introduced a patient alert card in April 2024 to increase awareness among men taking finasteride about potential psychiatric and sexual side effects.