The [EMA] concluded that a causal relationship between oral finasteride 1 mg and suicidal thoughts has been confirmed and that a positive benefit-risk ratio in the indication androgenic alopecia remains positive when appropriate risk mitigation measures are implemented. However, analysis of the data clearly revealed new aspects of the risks associated with psychiatric disorders and sexual dysfunction. These risks significantly alter the safety profile of oral finasteride 1 mg for the approved indication for androgenic alopecia… The expected benefits of stabilizing hair loss in this benign condition do not outweigh the severity of these risks, with potentially fatal consequences, in the target population of young, healthy patients. Consequently, Belgium considers that the benefit-risk ratio of finasteride 1 mg in androgenic alopecia is negative.
—New Risk Mitigation Measures for Finasteride and Dutasteride, FAMPH News: May 12, 2025