Momentum grows to modernize menopause care as FDA weighs new guidance

BY HPN Staff

The Food and Drug Administration (FDA) may soon make changes to what is known as the “black box warning” on hormone replacement therapy (HRT) for women in menopause.

Commissioner Dr. Martin Makary recently said the FDA is having “serious discussions” about the warning that “their use can increase the risk of uterine and breast cancers, as well as strokes and blood clots,” among other concerns. 

The warning was added when a 2002 government study reported the use of estrogen pills after menopause had a higher risk for some cancers, heart disease and stroke. Many of the study’s participants were past menopause when they started therapy.

Newer research has shown women younger than 60 or within 10 years of menopause may not have those same risks.

Why it matters

Menopause is the cessation of menstruation in women for 12 months as ovarian function declines, typically between the ages of 45 and 55. Symptoms include hot flashes, mood changes, sleep disturbance, and tendinopathy. Symptoms can be so severe that they disrupt daily life.

Menopause symptoms are often misdiagnosed due to a lack of physician training. This can drive up health care spending as patients seek testing and treatment for separate conditions and make repeat visits to their doctors. A Johns Hopkins survey showed that only 20% of OB/GYN doctors received menopause training during residency. Likewise, Mayo Clinic reported that only 7% of residents felt prepared to help women manage menopause.

Advocates say more efficient care will lead to overall cost savings. A recent study showed that women in menopause have 47% higher health care costs than those in other stages of life. However, when women receive appropriate treatment, such as hormone replacement therapy, those costs are reduced by 11%.

The bigger picture

The news comes as lawmakers are looking at new legislation to help the 1.3 million women who enter menopause each year.

• At least 15 state legislatures are considering new laws to address gaps in health care for women in menopause. 
• More than two dozen bills have been considered in statehouses across the nation this year, including raising public awareness, educating health care providers, and expanding insurance coverage for menopause treatment.
• At the federal level, the bipartisan “Advancing Menopause Care and Mid-Life Women’s Health Act” would authorize $275 million over five years to fund research, workforce training and public information.

Zooming in

As awareness of menopause grows, research and treatment options are expanding.

While new research shows that HRT, once avoided due to links to breast cancer, may offer benefits, though not suitable for all women.

New hormone-free treatments are also emerging. Recently, the FDA approved a new drug to treat hot flashes called Lynkuet, expected to hit the market in November.

“There is a need for more individualized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options,” Christine Roth, Bayer’s executive vice president of global product strategy and commercialization, said.