FDA removes black box warnings from three additional menopause treatments

The US Food and Drug Administration has removed black-box warnings for cardiovascular disease, breast cancer, and dementia from three additional menopause estrogen patches on October 30, 2026, the Guardian reported. [1]

According to the Guardian, the agency did not convene an advisory committee before making the decision. FDA officials offered few details regarding the scientific basis for removing the warnings during a press briefing, raising concerns among some experts about a lack of transparency. [1]

The decision follows the removal of black-box warnings from six other menopause treatments earlier in February, the Guardian reported. The agency's action comes as patients across the United States continue to struggle with access to care. [1]

As FTMQ News reported earlier, patients in other countries have also faced challenges with menopause care. Hundreds of thousands of women in Spain have experienced severe shortages of hormone replacement therapies for several months following supply chain disruptions. [2]