Regulatory Update: France’s FDA-Equivalent Agency Reissues Finasteride Warning

February 2, 2019

Dear Friends:

Prompted by an increasing number of adverse drug-reaction reports to finasteride, France’s FDA-equivalent agency yesterday issued a letter to 100,000 health professionals reminding them that patients treated with the drug are at risk for developing psychiatric disorders and persistent sexual disorders.

The Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), in conjunction with 17 finasteride manufacturers—including Merck & Co.’s local subsidiary, MSD France—sent its Letter to Health Professionals (English translation here) to general practitioners, dermatologists, psychiatrists, endocrinologists, andrologists, urologists, neurologists, geriatricians and community pharmacists nationwide.

The letter noted that “Adverse effects, such as psychiatric disorders, as well as sexual-function disorders, have been reported during and after the use of finasteride.” Specifically:

  • “Psychiatric Disorders: Anxiety, mood changes including depressive mood, depression and, less frequently, suicidal thoughts. The appearance of such symptoms should be closely monitored.”
  • “Sexual Disorders: Sexual dysfunction (including erectile dysfunction, ejaculation and decreased libido). Disorders of sexual function in some patients may persist after stopping treatment.”

In October 2017, ANSM issued its first finasteride warning, noting that “Changes in mood, particularly depression, and suicidal ideation, have been reported by patients taking Propecia.” Additionally, “finasteride treatment should be discontinued in the presence of any psychiatric symptoms,” and that “it is possible to observe persistent sexual disorders after stopping finasteride treatment.

Anyone living in the US who suffers from PFS should report his symptoms to the US Food and Drug Administration; anyone living outside the US who suffers from PFS should report his symptoms to the US Food and Drug Administration as well as to his national drug-regulatory agency, as directed on our Report Your Side Effects page.

Finally, If you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact the PFS Foundation as soon as possible via our Patient Support hotline:

Thank you.

Related News

France’s Le Monde to 300,000 Readers: Finasteride Users Beware (Feb. 1, 2019)

Regulatory Update: Germany’s FDA Equivalent Issues ‘Red Hand Letter’ on Finasteride ADRs (July 6, 2018)

French Warning of Propecia-Induced Depression and Suicidal Ideation Prompts Wave of Media Attention (Dec. 19, 2017)

Korea Mandates Propecia Label Change Based on Reports of Depression and Suicidal Ideation (July 15, 2017)

European Medicines Agency Recommends Adding Depression and Suicidal Ideation to Finasteride Label (April 10, 2017)