FDA announces removal of 'black box' warnings on some hormone therapies for menopause | full video
What this video covers
This CBS News segment captures the November 10, 2025 press conference at which HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced that the FDA would remove “black box” warnings — the agency’s most serious safety label — from many hormone therapy drugs used for menopause and perimenopause symptoms.
Makary argued the warnings, which dated to findings from the 2002 Women’s Health Initiative trial, had created a “fear machine” that kept women from a treatment he described as life-changing. He added a backstory not widely known: that the breast-cancer headline was released to the media before the underlying data was published, and that researchers met beforehand at a Chicago hotel where, he said, one scientist warned a colleague, “If you stir baseless fear around something so sensitive, that is breast cancer, you can’t put that genie back in the bottle.” He noted the trial’s estrogen-alone arm showed a 24% reduction in breast cancer and claimed no clinical trial has ever shown HRT increases breast-cancer mortality. The FDA’s position was that subsequent analysis showed a more nuanced risk picture, including a September 2025 re-analysis finding that women in their 50s taking estrogen faced no increased heart risk, while risks were clearer in women in their 70s.
The announcement was not without controversy. Critics noted the FDA had convened an invited panel of largely like-minded experts rather than a standing advisory committee, and that nearly 80 researchers later wrote to the agency requesting a formal committee meeting. Others argued the decision blurred distinctions between different hormone therapy formulations and delivery methods.
As announced, the boxed warning for endometrial cancer on systemic estrogen-alone products would remain in place, and the original warning language would still appear lower down in prescribing information.
Key points
- Kennedy and Makary announced removal of black-box warnings from many menopause hormone therapy products.
- Makary claimed the 2002 WHI findings were misrepresented, creating lasting fear of the drugs.
- The FDA cited a September 2025 re-analysis showing age-dependent risk: no increased heart risk in women in their 50s, clearer risk in women in their 70s.
- Newer low-dose formulations — creams, rings, tablets — were to get labels reflecting their own risk profiles.
- Critics argued the invited expert panel was ideologically narrow and that an official advisory committee should have weighed in.
- The endometrial-cancer boxed warning on systemic estrogen-alone products was retained.
- Makary framed the move as “stopping the fear machine” steering women away from treatment.