US FDA Approves Labeling Changes to Menopause Hormone Therapies

FDA OKs Safety Warning Update for Menopause Hormone Therapies

(MedPage Today) -- The FDA on Thursday approved label changes for six hormone replacement therapies (HRTs) that remove boxed warnings for cardiovascular disease, breast cancer, and probable dementia. For more than two decades, the boxed warnings...

FDA removes box warning for 6 menopausal therapies

The FDA has lifted longstanding and the most severe warnings off of hormone replacement therapies for menopausal women.

FDA Approves Labeling Changes to Menopausal Hormone Therapy Products

White Oak, Md., Feb. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as...

US FDA approves labeling changes to menopause hormone therapies

The U.S. Food and Drug Administration said on Thursday it has approved labeling changes to six menopause hormone therapies to remove references to risks of cardiovascular disease, breast cancer, and probable dementia.

FDA Approves Drug Labeling Changes to 6 Menopausal Hormone Therapy Products

The label change removes boxed warnings of cardiovascular disease, breast cancer, and probable dementia from certain hormone replacement therapy products.

FDA updates labels on multiple menopausal hormone therapies | Contemporary OB/GYN

The label changes to 6 menopausal HRTs "clarify risk considerations for these drugs," according to a statement from the FDA.