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U.S. Food and Drug Administration
A summary of label changes:
- 2001 – “Side effects went away in men who stopped taking Propecia”
- 2002 – Testicular pain added
- 2004 – Breast adverse events added
- 2010 – Breast enlargement added
- 2011 – First mention of depression; rare instances of breast cancer
- 2012 – Added reports of sexual adverse events that “continued after stopping the medication” and “male infertility / poor quality of semen”
- 2014 – Angioedema added to prescriber label
- 2021 – Hematospermia added to prescriber label
- 2022 – FDA requires 1) addition of suicidal ideation and behavior to postmarketing events; 2) addition of sexual adverse events to Patient Counseling Information
Learn more: Adverse effects in the Propecia label: a history of changes
See documents on FDA approval of Proscar and Propecia in the document library.
Posts on FDA
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
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