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Regulation overview

History (highlights)

1992: Proscar approved by U.S. Food and Drug Administration

1997: Propecia approved by FDA

2001: Merck submits Supplementary New Drug Application to FDA with 5-year extension trial data

2008: Sweden adds warning of persistent sexual dysfunction associated with finasteride (1 mg)

2012: US FDA requires a revision to the Propecia label including: “decrease in sex drive that continued after stopping the medication;” “problems with ejaculation that continued after stopping medication;“ and “difficulty in achieving an erection that continued after stopping the medication.”

2021: US FDA requires the addition of hematospermia (blood in semen) to the Postmarketing Experience section of the Propecia label. (Source: FDA letter)


US FDA requires “addition of suicidal ideation and behavior to…the ADVERSE REACTIONS (Postmarketing Experience) section of the Propecia labeling.” (Sources: FDA response (p. 43) • Reuters story)

French regulator ANSM announces the addition of a red box warning to packaging, a new patient information site and patient information sheet.


Health Canada publishes a safety review which found a “possible link between the use of finasteride and the risks of suicidal ideation and self-injury.”

The UK’s Medicines and Healthcare Products Agency (MHRA) will launch a safety review of finasteride (Source: The Daily Mail)

France’s ANSM announces that red boxed warnings have been added to packaging of finasteride 1 mg. The warning states “unwanted sexual and/or psychiatric effects can arise during and after treatment” and includes a QR code linking to an information packet. Organon, the authorized marketer, takes the drug off the market in France, but it remains available in generic form.

On June 2, PFS Network holds an FDA Patient Listening Session on post-finasteride syndrome, with representatives from 16 FDA offices attending. Summary (PDF) • About Patient Listening Sessions

See also a general timeline and a history of label changes in the U.S.

Regulatory bodies

  • United States: Food and Drug Administration (FDA)
  • Canada: Health Canada
  • Europe: European Medicines Agency (EMA)
  • France: Agence nationale de sécurité du médicament et des produits de santé (ANSM)
  • Sweden: Swedish Medical Products Agency
  • United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA)
  • Australia: Therapeutic Goods Administration
  • Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
  • Korea: Ministry of Food and Drug Safety (MFDS)


How to access clinical trial data from RIAT Initiative

Posts on regulation