In an announcement today, the FDA has explained its decision to revise the labeling of hormone replacement therapy (HRT) products based on reevaluation of older studies in light of new data. The FDA recognizes a difference between the risks associated with oral HRT products vs. vaginally applied HRT products and the labeling changes reflect this difference.

The FDA explains the value of HRTs and notes that the patient population that is actually bothered most by severe menopausal symptoms is largely women who are younger than those for whom data had been gathered to support development of the current labeled warnings. The FDA also recognized that, due to the warnings, the use of HRTs has declined over time and postulated that the decrease in use is based on the warnings contained in current labeling.

To gain a full understanding of the history of HRT labeling and the FDA’s rationale for the label revisions, please see the announcement here. The summary of proposed changes to HRT labeling are provided below.

  • For all MHTs (systemic and local vaginal products):
    • Specifically, in the label’s Boxed Warning, the Agency’s most prominent safety-related warning:
      • Remove the language related to cardiovascular diseases, breast cancer, and probable dementia
      • Remove language related to endometrial cancer except in the systemic estrogen-alone drugs
      • Remove the recommendation to use the lowest effective dose for the shortest amount of time
    • In the labeling as a whole:
      • Remove the probable dementia warning

In addition to the above changes:

  • For systemic products:
    • In the labeling as a whole:
      • Add consideration of starting hormone therapy for moderate to severe vasomotor symptoms (VMS) in women < 60 years old or < 10 years since menopause
      • Add Women’s Health Initiative (WHI) data for women 50-59 years old
      • Retain the Boxed Warning about endometrial cancer in the systemic estrogen-alone products
      • Retain information about cardiovascular diseases and breast cancer warnings
  • For local vaginal estrogen products:
    • In the labeling as a whole:
      • Condense safety information and prioritize information most relevant to the local vaginal formulation

These changes represent a significant revision from previous required labeling for HRT products and reflect the most current FDA thinking on the actual risks associated with products relative to their substantial benefits to women who suffer from significant menopausal symptoms.