Drugs

Changes Coming to HRT Boxed Warning: Makary

FDA commissioner Martin Makary says changes easing the Boxed Warning on hormone replacement therapies should be announced soon. “We are in serious discussion now about what to do about the black box warning, and I think you’ll hear something on it very soon,” Makary said on a CNN podcast.

Since 2003, a Boxed Warning for menopause treatments that contain estrogen has stated that the products can increase the risk of uterine and breast cancers, as well as strokes and blood clots. The labeling also warns of an increased risk of dementia for women over 65.

CNN reports the Boxed Warning was added after a large government-funded study found that women taking estrogen pills after menopause had a higher risk for some cancers, heart disease, and stroke compared with women taking a placebo. After the study and labeling change, it says, 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,” Makary said. “It’s maybe one of the greatest screw-ups of modern medicine. It’s resulted in 50 million women being denied this incredible therapy.”

The report says newer analyses of the original Women’s Health Initiative study found that hormone therapy started in women younger than 60 or within 10 years of starting menopause may safely help manage menopausal symptoms as long as the women don’t have specific contraindications such as a history of hormone-sensitive breast or uterine cancer.

“Women live longer and feel better on hormone replacement therapy when started before age 60,” Makary said.

A change to the Boxed Warning would be in line with the July recommendations from the agency’s Expert Panel on Menopause and Hormone Replacement Therapy in Women.

“I am begging FDA, and all of us are begging, please remove the Box[ed] label,” said University of Virginia School of Medicine professor of obstetrics and gynecology JoAnn Pinkerton at the panel session. “And please stop harming women.”

CNN says some women’s health experts believe the agency overreached when it put the Boxed Warning on labels for all forms of estrogen replacement, since low doses delivered by vaginal tablets, creams, or rings can safely treat some menopausal symptoms. There is evidence, however, indicating that a warning statement may still be needed for pills containing estrogen that are taken orally.

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