Health and Human Services Secretary Robert F. Kennedy Jr. announced Monday that the U.S. Food and Drug Administration would remove “broad black box” warnings from hormone replacement therapy products for menopause.
The estrogen-related products used to treat hot flashes and other symptoms for decades will no longer carry a warning label about cardiovascular disease, breast cancer and probable dementia.
The warning will not be removed for the risk of endometrial cancer for systemic estrogen-alone products.
“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 said in a statement.
“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.”
As women experience menopause in their forties and fifties, their ovaries produce less of the sex- and reproductive-regulating hormones estrogen and progesterone.
Hormone replacement therapy products can restore declining hormones and relieve uncomfortable symtpoms, including night sweats and bone loss.
But Kennedy and FDA Commissioner Marty Makary said that the labels had scared women off from the treatment.
“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,” said Makary.
Monday’s announcement comes following an expert literature review conducted in July. The FDA is now working with drugmakers to update and reprint labels.
The FDA also said it had approved two new drugs to expand treatment options for menopausal symptoms, including a generic version of Premarin and a non-hormonal medication to treat hot flashes and other symptoms related to blood vessels widening and constricting.
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