The European drugs regulator's safety committee confirmed on May 8, 2025, that suicidal thoughts are a side effect of Organon's anti hair-loss drug finasteride. This confirmation follows an EU-wide review of the drug.
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) agreed that suicidal ideation should be included as a side effect for finasteride 1 mg and 5 mg tablets. Finasteride is branded as Propecia by Organon.
This regulatory action reinforces existing warnings about psychiatric side effects for finasteride. The confirmation could lead to further scrutiny and potential impacts on the prescribing information and market perception of the drug.
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