Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines

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. The frequency of the side effect is unknown, meaning that it is not possible to estimate it from available data. Most cases of suicidal ideation were reported in people using 1 mg finasteride tablets, which are used to treat androgenetic alopecia (hair loss due to male hormones). 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. The product information for finasteride 1 mg tablets 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), which are known side effects of the medicine and may contribute to mood changes. A patient card will be included in the packages of 1 mg finasteride tablets to remind patients of these risks and to advise them about the appropriate course of action. The recommendations follow a review of the risks of suicidal thoughts and behaviours with finasteride and dutasteride medicines. The PRAC agreed that suicidal ideation should be included as a side effect of finasteride tablets...