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US to remove warnings from menopause hormone therapy - World News


US to remove warnings from menopause hormone therapy - World News

The United States will remove strong safety warnings on many hormone therapies used to alleviate menopausal symptoms, saying the risks have been exaggerated, authorities announced on Nov. 10.

Hormone Replacement Therapy (HRT) replaces estrogen that the female body stops producing during menopause with the aim of alleviating symptoms including hot flashes, brain fog, insomnia, night sweats and joint pain.

Previously used routinely, prescription and use of the therapies have plummeted worldwide since a landmark trial in the early 2000s pointed to risks associated with specific HRT formulations.

Since then "black box warnings," the strongest warning the U.S. Food and Drug Administration can require on prescription drugs, have sounded alarm over increased HRT risks including of certain cancers, cardiovascular conditions and probable dementia.

But critics have pointed to flaws with the early 2000s Women's Health Initiative, whose trials were halted as risks appeared: Namely it focused on women who were a decade-post-menopause and in their 60s, when cardiovascular risks increase regardless.

Today guidance generally indicates that healthy newly menopausal or perimenopausal women, people broadly in their 40s or 50s, are among potential candidates for treatment.

There also are newer, more localized or lower-dose forms of the therapies available.

"We're challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts," U.S. health chief Robert F. Kennedy Jr said in introducing the measure.

Many experts had urged revisiting the black box label, which they say can scare women for whom benefits may outweigh risks.

Others have voiced concern that changes shouldn't come without a rigorous review process.

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