The European Medicines Agency (EMA) announced on October 4, 2024, that it is reviewing anti hair-loss drugs, including Organon's Propecia (finasteride) and its generic versions, due to concerns regarding the risk of suicidal thoughts. The EMA will recommend whether the marketing authorizations for these drugs should be withdrawn, suspended, or maintained across the region.
Oral anti-baldness drugs containing finasteride and dutasteride have a known risk of psychiatric side effects. Propecia, specifically, already carries warnings about the risk of suicidal thoughts.
Organon stated it will collaborate closely with the European Medicines Agency and stands behind the safety and efficacy of its finasteride medicines. This review could impact the sales and market positioning of Propecia within the European Union.
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