The European Medicines Agency (EMA) has announced new safety measures for finasteride- and dutasteride-containing medicines to decrease the risk of suicidal ideation. These updates aim to increase awareness among healthcare professionals and patients regarding possible mood-related side effects associated with these treatments.
Lower-dose oral finasteride (1 mg) is used to treat early-stage male pattern hair loss (androgenetic alopecia), while a topical finasteride spray (2.275 mg/mL) is approved for the same indication. Higher-dose oral finasteride (5 mg), alone or combined with tadalafil or tamsulosin, is indicated for benign prostatic hyperplasia (BPH) and the prevention of related urologic events. Dutasteride, available only in oral form and sometimes combined with tamsulosin, is also indicated for BPH management. Both finasteride and dutasteride products carry known risks of psychiatric side effects, which are reflected in their product information.
Suicidal ideation has been reported in some patients using oral finasteride, mainly in those treated for androgenetic alopecia (male pattern hair loss). Patients who experience symptoms such as depressed mood, depression, or suicidal thoughts should stop the medication and seek medical advice immediately. Sexual dysfunction, which may contribute to mood changes, has also been reported and should be discussed with a healthcare professional.
To reinforce patient awareness, a new patient information card will be included in finasteride 1 mg packaging to highlight the risks of depression, suicidal thoughts, and sexual dysfunction. Although current evidence does not confirm a direct link between dutasteride and suicidal ideation, patients taking dutasteride are also advised to seek medical help if they notice any changes in their mood.
Finasteride and dutasteride are frequently used 5-alpha reductase inhibitors indicated for male pattern hair loss and benign prostatic hyperplasia. The EMA’s review of reported cases found that most instances of suicidal ideation occurred among patients using finasteride for hair loss. The review reached conclusion that suicidal ideation should be considered a potential adverse reaction to these medicines, though its frequency cannot be estimated from available data.
Healthcare professionals are asked to monitor patients for any mood changes, counsel them about possible side effects, and report suspected adverse reactions through national pharmacovigilance systems.
