Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 May 2025

Finasteride and dutasteride tablets: Measures to minimise risk of suicidal thoughts Following an EU-wide review of available data on finasteride and dutasteride medicines, EMA’s safety committee (PRAC) has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1 and 5 mg tablets but concluded that the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses. The frequency of the side effect is unknown, meaning that it is not possible to estimate it from available data. A warning about mood changes, including depression, depressed mood and suicidal ideation, is already included in the product information for finasteride medicines. Patients who experience mood changes should seek medical advice and, if taking finasteride 1 mg, should also stop treatment. Most cases of suicidal ideation were reported in people using 1 mg finasteride to treat hair loss due to male hormones. The product information for finasteride 1 mg will now also alert patients about the need to seek medical advice if they experience problems with sexual function (such as decreased sex drive or erectile dysfunction) that have been reported to contribute to mood alterations and suicidal ideation in some patients. A patient card will be included in the 1 mg finasteride package to remind patients of these risks and to advise them about the appropriate course of action.  Although a link between suicidal ideation and dutasteride was not...