RFK Jr. says FDA taking ‘black box’ warnings off menopause hormone therapy drugs
How menopause treatment will change after major announcement
- The U.S. Food and Drug Administration is removing broad “black box" warnings from over 20 hormone replacement therapy (HRT) products used to alleviate menopause symptoms.
- These warnings, which previously warned of risks such as cardiovascular disease, breast cancer, and probable dementia, will no longer appear on estrogen-related products.
- Health and Human Services Secretary Robert F. Kennedy Jr. stated this decision marks a return to "evidence-based medicine," aiming to empower women in managing their health.
- The original warnings were implemented after a 2002 study, but subsequent research and re-analysis indicated no increased heart problem risk for women in their fifties using estrogen-based drugs.
- While warnings for endometrial cancer on systemic estrogen-alone products will remain, the FDA has also approved two new drugs to expand treatment options for menopausal symptoms.