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