RFK Jr. says FDA taking ‘black box’ warnings off menopause hormone remedy medication | EUROtoday

Health and Human Services Secretary Robert F. Kennedy Jr. introduced Monday that the U.S. Food and Drug Administration would take away “broad black box” warnings from hormone substitute remedy merchandise for menopause.

The estrogen-related merchandise used to deal with scorching flashes and different signs for many years will now not carry a warning label about heart problems, breast most cancers and possible dementia.

The warning won’t be eliminated for the danger of endometrial most cancers for systemic estrogen-alone merchandise.

“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” Kennedy mentioned in an announcement.

“For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT,” he added. “We are returning to evidence-based medicine and giving women control over their health again.”

Kennedy and FDA Commissioner Marty Makary mentioned that the labels had scared ladies off from the therapy.

“Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk,” mentioned Makary.

The announcement comes following an professional literature overview carried out in July. The FDA is now working with drugmakers to replace and reprint labels.

The FDA additionally mentioned it had authorised two new medication to develop therapy choices for menopausal signs, together with a generic model of Premarin and a non-hormonal medicine to deal with scorching flashes and different signs associated to blood vessels widening and constricting.

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