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EU Launches Safety Review Of Finasteride And Dutasteride Over Suicidal Thoughts And Behavior

 
• By Ian Schofield

France’s regulatory agency, which triggered the review, says it believes that the addition of suicidal ideation to the product information for finasteride and reports of cases of completed suicide “seriously alter” the product’s benefit-risk profile. 

Businessman showing risk level indicator rating since low to high for risk management and assessment review concept
The EU is weighing the risks of two 5-alpha reductase inhibitors • Source: Shutterstock

The European Medicines Agency has launched a safety review of medicines containing finasteride and dutasteride after the French regulator raised concerns about continuing reports of psychiatric disorders including suicidal ideation and sexual dysfunction, despite the measures that have been taken to address these potential side-effects.

The EMA said its drug safety committee, the PRAC, would analyze all available data linking the two substances to suicidal ideation and behavior and evaluate the impact on the drugs’ benefit-risk balance,

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