(Reuters) -The U.S. Food and Drug Administration has initiated the removal of the agency’s strictest “black box” warnings from hormone therapies given to women to treat menopause symptoms, according to the health regulator’s website.
The FDA’s decision follows a comprehensive review of scientific literature, an expert panel in July, and a public comment period.
The agency said it is working with drug manufacturers to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia.
Hormone replacement therapy for menopause replenishes the hormones, primarily estrogen, that decline with menopause to relieve symptoms like hot flashes and vaginal dryness.
All menopause treatments containing estrogen carry a warning that it increases the risk of strokes, blood clots and perhaps dementia. It also warns of the possibility of breast cancer.
In addition to the removal of boxed warnings, the FDA is also approving two new drugs for menopausal symptoms which include a generic version of Pfizer’s Premarin and a non-hormonal treatment for moderate to severe vasomotor symptoms, such as hot flashes, associated with menopause.
A black box warning is the most severe the FDA can place for a prescription medication, indicating serious or potentially fatal side effects.
“With the exception of vaccines or antibiotics, there’s no medication that can improve the health of women on a population level more than hormone replacement therapy,” FDA Commissioner Marty Makary said in a post on X.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shailesh Kuber)
