US FDA approves labeling changes to menopause hormone therapies

Feb 12 (Reuters) – 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.

The FDA had initiated the removal of the strictest “black box” warnings in November in a move to boost access to these treatments long shunned by patients and doctors over safety fears.

The agency said 29 drug companies have submitted proposed labeling changes.

The first group of six hormone therapies includes estrogen-only and progestogen-only products such as Prometrium, Divigel, Cenestin and Enjuvia, along with the combination therapy Bijuva and the topical vaginal estrogen treatment Estring.

Hormone replacement therapy, or HRT, replenishes the hormones, primarily estrogen, that decline with menopause to relieve symptoms like hot flashes and vaginal dryness.

HRT was widely prescribed, including to protect women from chronic diseases, especially heart disease, for decades. But its use plunged after a 2002 Women’s Health Initiative study found it could raise the risk not only of breast and ovarian cancer, but also of strokes and other serious conditions.

Of about 41 million U.S. women aged 45 to 64 in 2020, only about 2 million received a hormone-therapy prescription, the agency said.

(Reporting by Mariam Sunny in Bengaluru; Editing by Shailesh Kuber)