FDA scraps "black box" warning from menopause hormone therapy

The Food and Drug Administration on Monday said that it's removing the "black box" warning on hormone replacement therapy for menopause.

Why it matters: The change could make women more willing to take — and doctors more willing to prescribe — hormone treatments that ease the many symptoms of menopause.

Driving the news: FDA said it is removing references to risks of cardiovascular disease, breast cancer and probable dementia on product labels.

• FDA will keep the warning of endometrial cancer risk on the packaging of systemic estrogen.
• The products currently have the highest-level safety risk warning on their label, the so-called black box, which alerts patients to the potential of serious side effects.
• The agency also said it approved two new drugs for menopausal symptoms: a generic version of the hormone therapy Premarin, and a non-hormonal treatment for moderate to severe vasomotor symptoms, such as hot flashes, associated with menopause.

Context: Hormone treatments for menopause have been required to include a warning of potential life-threatening side effects on packaging since 2003, after a federally-funded study suggested the treatments increased the risk of breast cancer, stroke and heart disease.

• The study led many providers to stop prescribing the treatments.
• More recently, doctors and women's health advocates have argued that the study results have been taken out of context, and the benefits of these therapies outweigh the risks for many.
• "We now know, after having reevaluated that data and doing additional research, that menopause hormone therapy is safe for a much broader range of people than we had previously understood," said Nora Lansen, chief medical officer at Elektra Health, a menopause care telehealth company.

Monday's decision follows a July endorsement to remove the warning, issued by an expert panel of doctors handpicked by FDA.

• FDA Commissioner Marty Makary has made it clear that he thinks the black box warning requirement is a "screw up."

What they're saying: "With the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy," Makary and other senior agency officials wrote in an editorial published Monday in JAMA.

The other side: Some physicians continue to interpret the research as showing more harm than good from these therapies, and argue against medicalizing menopause.

Zoom out: Conversations about menopause and women's health during midlife have gone from taboo to mainstream in recent years.

• A January report from Women's Health Access Matters and KPMG found that the menopause market — including drugs, holistic treatments and apps — is forecasted to reach $27 billion by 2030.

Go deeper: Menopause makes it on the policy map