REGULATORY ACTIVITY

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Regulation overview

History (highlights)

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

1997: Propecia approved by FDA

1998–99: Finasteride (1 mg) approved in numerous countries in Europe, South America and Asia as well as Canada and Australia (Source: Supplemental NDA for Propecia pp. 130–131 via Propecia Litigation Library)

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)

2022

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.

2023

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.

Approvals by country

Source: Supplemental NDA for Propecia, March 27, 2001, pp. 130–132. Via Propecia Litigation Library.

Table D-1. “Countries Where Finasteride (1-mg) Tablets has Received Marketing Approval for the Treatment of Male Pattern Hair Loss”

CountryApproval date
Argentina27-Feb-1998
Aruba23-Feb-2000
Australia26-Jun-1998
Brazil29-Apr-1998
Bulgaria14-Jul-1999
Canada26-Jun-1998
Colombia18-Mar-1999
Costa Rica22-Jun-1998
Croatia23-Nov-1998
Curacao13-Feb-2000
Cyprus17-Aug-1999
Czech Republic21-Apr-1999
Chile16-Jun-1999
Denmark04-Nov-1998
Dominican Republic15-Oct-2000
Ecuador11-Aug-1998
El Salvador02-Jun-1999
Estonia11-Dec-1998
Finland02-Nov-1998
France23-Dec-1998
Germany10-Dec-1998
Guatemala24-Aug-1998
Honduras25-Aug-1999
Hong Kong02-Feb-1999
Iceland17-May-1999
Israel25-Aug-1998
Italy17-Feb-1999
Jamaica21-Oct-1999
Korea13-Mar-2000
Kuwait16-Mar-1999
Lithuania27-Nov-1998
Malaysia06-Oct-1999
Mexico11-Sep-1997
New Zealand30-Nov-1997
Nicaragua22-Jul-1999
Panama16-Jul-1999
Peru08-Mar-1999
Philippines28-Jun-1999
Poland24-Nov-1999
Portugal28-Dec-1998
Romania16-Jun-1998
Singapore05-Aug-1998
Slovak Republic28-Oct-1999
Slovenia19-Mar-1999
South Africa05-May-1999
Spain02-Feb-1999
Sweden17-Apr-1998
Switzerland21-Oct-1998
Taiwan08-Sep-1999
Thailand15-Feb-1999
Trinidad/Tobago25-Oct-1999
Turkey29-Jan-2001
United Kingdom20-Sep-1999
United States19-Dec-1997
Venezuela08-Sep-1999

Table D-3. “Countries With Applications Pending for Finasteride 1 mg”

CountryFiling date
Bolivia21-Jul-1998
China17-Mar-1998
Egypt07-Jan-2000
Haiti02-Nov-2000
Hungary03-Jun-1997
Latvia07-May-1998
Uruguay23-Oct-1998

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)

Research

How to access clinical trial data from RIAT Initiative


Posts on regulation

  • 2023 – year in review

    Fitness influencers and physicians raised alarms about risks of finasteride for hair loss this year, reaching millions of people through tweets, videos and podcasts. On the regulatory front, in France boxed warnings were added to finasteride packaging. Health Canada added a warning about suicidality while the UK regulator launched a safety review. Forty-four relevant research… Read more

  • Regulators are waking from their slumber

    Agencies in France, the United Kingdom, Canada and the United States are strengthening warnings about finasteride risks Read more

  • FDA quashed internal warning on suicidality linked to Propecia; changed course in 2022

    In 2010, Merck requested to add a warning of depression to the Propecia label. A safety group within FDA concurred, but FDA’s dermatology products group did not support the change. Over a decade later, FDA required the addition of ‘suicidal ideation and behavior’ to the Propecia label. Read more

  • The Merck files, part 2: Merck responds to regulatory concerns about persistent adverse effects of Propecia

    In 2006, the Swedish Medical Products Agency asked Merck for an analysis of all adverse events affecting the male reproductive system which persisted after stopping Propecia. In subsequent documents, there is a back-and-forth between Merck and the Agency as to the validity of these reports and the overall safety concern. Merck used an arsenal of… Read more

  • The Merck files, part 1: An inside look at the development of Propecia

    Merck first developed finasteride for benign prostatic hyperplasia, a condition typically found in men aged 55 and older. After receiving approval for the application in 1992 and bringing the drug to market as Proscar, Merck decided to seek approval of finasteride for male pattern hair loss—to be branded as Propecia. In a 1994 memo below,… Read more

  • The Merck files: a series

    Selected documents from Propecia litigation were released by court order in 2021. This series walks through these documents, revealing Merck’s strategy for discounting safety concerns arising from clinical trials and adverse event reports. The collection is divided into three parts: 1. An inside look at the development of Propecia (1994–2001) 2. Merck responds to regulatory… Read more

  • Adverse effects on the Propecia label: a history of changes

    In its Drugs@FDA database, FDA has at least nine versions of the Propecia label going back to 2001. This post will trace the history of changes to adverse effects in the label for consumers. A summary of label changes: 2001 – “Side effects went away in men who stopped taking Propecia” “A small number of… Read more

  • 2012 revision of Propecia label contained new warnings, even though FDA said it didn’t

    It seems the 2012 statement from FDA — that these labeling changes are not new warnings — was incorrect. Read more