FDA to Remove Black Box Warnings on Hormone Replacement Therapy

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Pharmacist rifling through medication storage drawers — The FDA will remove black box warning labels on HRT products, which the agency states has sown confusion around hormone therapy for menopause. Lupe Rodriguez/Stocksy

The Food and Drug Administration (FDA) announced the removal of black box warnings on hormone replacement therapy (HRT) treatments for menopause.
The federal agency has requested that HRT manufacturers update wording regarding various risks, such as cardiovascular disease, breast cancer, and dementia.
Experts say removing the warnings could help reduce stigma around HRT and facilitate a dialogue between individuals and healthcare professionals.

The Food and Drug Administration (FDA) announced on Monday that it will remove the strictest black box warning labels for hormone replacement therapy (HRT) products used to treat menopause symptoms.

Black box warnings are issued by the FDA to highlight serious risks of major injury or death associated with a medication.

Black box warning labels have been included on HRT products for more than two decades, which the agency said has sown fear and confusion around hormone therapy, the FDA stated in a news release.

“For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT,” Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement. “We are returning to evidence-based medicine and giving women control over their health again.”

FDA Commissioner Marty Makary, MD, MPH, said that millions of women have been denied the potential health benefits of HRT during menopause due to “distorted” risk factors included on the warning labels.

“For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear,” Makary said in a statement.

The FDA is requesting that HRT manufacturers update the language on black box warnings pertaining to cardiovascular disease, breast cancer, and dementia risks. However, the FDA is not seeking to remove the warnings regarding endometrial cancer on systemic estrogen-alone products.

This decision is based on an FDA assessment of current literature and a comprehensive review by a panel of experts, which includes a reanalysis of data from younger cohorts who began HRT treatment within 10 years of entering menopause. Here’s what you need to know.

Black warning labels and hormone therapy stigma

HHS states that removing black box warnings from HRT products could help address the underutilization of these products to treat menopause symptoms. Experts are in agreement.

“The FDA removal of the black box warning for HRT will increase clinician awareness and education across all fields of medicine, and will ultimately expand access to appropriate, individualized treatment for those experiencing menopause,” said Nataki Douglas, MD, reproductive endocrinologist and chief scientific officer at Extend Fertility.

HRT was first approved by the FDA to treat certain menopause symptoms in 1941. However, studies conducted in the 1990s by the Women’s Health Initiative (WHI) found that there were potential risks of cardiovascular disease, breast cancer, and pulmonary embolism. Following these studies, the use of HRT fell by 45%.

“Initially, the ‘black box’ warning cautioned women and healthcare providers that hormone therapy would increase their risks of blood clots, breast cancer and strokes, which was based on the notorious and faulty WHI study done in 2002,” said Sherly Ross, MD, a board certified OB-GYN and women’s health expert noted this about the initial use of the black box warning and what the removal means.

“After over 20 years of waiting, we now have a restored trust and confidence in safely using hormone therapy for menopausal women as a recommended medication for quality of life and healthy aging,” Ross told Healthline.

Future of menopause treatment

Experts say that removing the black box warnings from HRT products will improve menopause treatment outcomes for symptoms ranging from hot flashes to night sweats and sleep issues.

“For the 6,000 [U.S.] women entering menopause every day, they will not only get relief from the disruptive symptoms of menopause, but will also have a reduced risk of heart disease, cognitive decline, and bone fractures,” Ross said.

She said the benefits of hormone therapy become even more pronounced when the medication is prescribed within the first 10 years of menopause onset.

“Starting hormone therapy is an individualized process that should be discussed with a qualified healthcare provider, weighing the benefits versus the risks,” Ross said.

Douglas echoed these remarks, calling the black box removal an “important first step” that raises awareness among clinicians and patients alike about the evidence-based benefits and risks of HRT.

“It will encourage more open and informed patient–provider discussions and lead to increased referrals of perimenopausal and postmenopausal individuals to specialists who provide menopause-focused care,” Douglas told Healthline.