Changes to ‘black box’ warning on hormone therapy for menopause symptoms expected soon, FDA chief says

The FDA may act "soon" on the black box warning on hormone replacement products for women with menopause symptoms. Maansi Srivastava/The Washington Post/Getty Images

The US Food and Drug Administration plans to make changes soon to the lengthy black box warning on many hormone replacement products for women with menopause symptoms, Commissioner Dr. Martin Makary said.

“We are in serious discussions now about what to do about the black box warning, and I think you’ll hear something on it very soon,” Makary told CNN Chief Medical Correspondent Dr. Sanjay Gupta in the “ Chasing Life ” podcast.

The black box warning is the strongest type of alert the FDA puts on a drug label. Since 2003, labels of menopause treatments that contain estrogen – including pills, patches, sprays and creams