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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