Starting April 16, finasteride 1 mg, a treatment prescribed to nearly 30,000 men to slow hair loss, will be subject to stricter regulations in France. All dispensing of the medication will now require a certificate co-signed by the patient and their doctor, attesting that the potential risks, particularly psychiatric and sexual risks, have been clearly explained. This document must be presented at the pharmacy and renewed annually.
This new procedure also applies to patients already undergoing treatment. However, they have until mid-June to consult their doctor and obtain the required certificate.
This tightening of regulations comes after several years of warnings from the French National Agency for Medicines and Health Products Safety (ANSM). The health authority regularly warns of adverse effects that can include suicidal thoughts. Despite these warnings, specialists believe that the overall benefit-risk ratio of finasteride remains favorable.
Pascal Lemontel
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