Nov 10 (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 ( PFE ) 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.