FDA on hormone therapy: facts vs. fear

The black box warning on hormone treatments for menopause could soon be gone, as an FDA expert panel recommended that the agency’s policy on the issue follow more-recent science. That science has shown that benefits of the treatment outweigh the potential risk of heart issues (risks that were suggested in a study almost a quarter of a century ago). Even the original study’s authors agree that the alarm over the study wasn’t justified. 

The panel’s recommendation — which is non-binding, but carries significant weight — came on the heels of a July 16 public meeting hosted by FDA Commissioner Marty Makary and Deputy Commissioner Sara Brenner. The panel at that meeting concluded that the black-box warning on low-dose estrogen products is based on outdated information and a misinterpreted  study, leading to decades of women being unnecessarily denied (or avoiding) estrogen therapy that could have significantly improved their qualities of life.

The panelists also called for FDA to approve testosterone therapy for women, emphasizing that women deserve equitable access to therapies that have long been available for men. (The agency is planning an open comment period on this topic as early as next week.)

You can watch a recording of the panel discussion here.