Is Hormone Replacement Therapy Safe?

There is a lot of confusion about whether or not hormone replacement therapy is safe. The medications carry an intimidating “black box” warning that scares many women away from getting relief that might be beneficial.

But, changes to ‘black box’ warning on hormone therapy for menopause symptoms are expected soon, FDA chief says

The FDA may act “soon” on the black box warning on hormone replacement products for women with menopause symptoms. Maansi Srivastava/The Washington Post/Getty Images

Is Hormone Replacement Therapy Safe in 2025? FDA May Update Warning

The US Food and Drug Administration plans to make changes soon to the lengthy black box warning on many hormone replacement products for women with menopause symptoms, Commissioner Dr. Martin Makary said.

“We are in serious discussions now about what to do about the black box warning, and I think you’ll hear something on it very soon,” Makary told CNN Chief Medical Correspondent Dr. Sanjay Gupta in the “Chasing Life” podcast.

 

Why the Black Box Warning?

The black box warning is the strongest type of alert the FDA puts on a drug label. Since 2003, labels of menopause treatments that contain estrogen – including pills, patches, sprays and creams – have warned that their use can increase the risk of uterine and breast cancers, as well as strokes and blood clots. The labels also warn about an increased risk of dementia for women over the age of 65.

  • The warning was added after a large government-funded study found that women taking estrogen pills after menopause had higher risks for some kinds of cancers, heart disease and stroke compared with women who took a placebo.
  • The study participants had an average age of 63, so many were past menopause when they started the therapy.
  • After the study and the label change, prescriptions for hormone replacement therapy drugs for women dropped by more than 70%, and doctors became reluctant to prescribe them.
  • “It’s really a tragedy. It’s maybe one of the greatest screw-ups of modern medicine,” Makary said. “It’s resulted in 50 million women being denied this incredible therapy.”
  • US Food and Drug Administration Commissioner Dr. Martin Makary said the agency is in “serious discussions” about the black box warning on hormone therapy for menopause symptoms.

 

Why the Warning May Be Withdrawn?

US Food and Drug Administration Commissioner Dr. Martin Makary said the agency is in “serious discussions” about the black box warning on hormone therapy for menopause symptoms. Brendan Smialowski/AFP/Getty Images

The result has been undertreatment of symptoms that can be debilitating for women in midlife. In the late 1990s, more than 1 in 4 postmenopausal women were taking hormones to manage symptoms such as hot flashes, mood swings and night sweats. By 2020, that number had dropped to about 1 in 25, one study found.

  • Newer analyses of the original study, called the Women’s Health Initiative, have since found that hormone therapy started in women younger than 60, or within 10 years of starting menopause, may safely help manage menopausal symptoms such as hot flashes and poor sleep as long as the women don’t have specific contraindications such as a history of hormone-sensitive breast or uterine cancer.
  • Makary also said hormone replacement therapy may also have important benefits like reducing bone loss, heart disease risk and memory loss,

CNN report on how the FDA may update its warning on hormone replacement therapy

Need help navigating menopause or hormone therapy options? Contact Certified Nutritionist Lorie Eber at Eberlorie@gmail.com — expert support is just an email away.