Home / Health / FDA Lifts Hormone Therapy Safety Warnings
FDA Lifts Hormone Therapy Safety Warnings
13 Feb
Summary
- FDA approved labeling changes for six menopause hormone therapies.
- References to cardiovascular, cancer, and dementia risks were removed.
- This aims to boost patient and doctor confidence in HRT treatments.
The U.S. Food and Drug Administration announced on February 12, 2026, that it has approved labeling updates for six menopause hormone therapies. These updates will remove references to potential risks associated with cardiovascular disease, breast cancer, and probable dementia.
The FDA initiated this move in November, seeking to eliminate the most stringent "black box" warnings. The agency aims to improve access to these treatments, which have faced significant avoidance from patients and healthcare providers due to safety fears.
The approved therapies include a mix of estrogen-only, progestogen-only, and combination treatments. These include Prometrium, Divigel, Cenestin, Enjuvia, Bijuva, and Estring. Hormone replacement therapy (HRT) replenishes declining hormones during menopause to alleviate symptoms like hot flashes and vaginal dryness.
Historically, HRT was widely prescribed, even for chronic disease prevention. However, its use declined dramatically after a 2002 study linked it to increased risks of cancer, strokes, and other serious conditions. As of 2020, only about 2 million out of approximately 41 million U.S. women aged 45 to 64 used hormone therapy.
