REGULATORY ACTIVITY
Overview • US FDA • Health Canada • European Medicines Agency (EMA) • France • Germany • Sweden • United Kingdom • Australia • Japan • Korea • Document library • Posts
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)
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)
US FDA announces a Patient Listening Session on post-finasteride syndrome.
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)
Research
How to access clinical trial data from RIAT Initiative
Posts on regulation
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 arguments to discount these reports and claim its own data is superior to postmarketing data. 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 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 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” 2002 – Testicular pain … Read more 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