The Food and Drug Administration will remove black box warnings from hormone replacement therapy (HRT) products, which are often used to treat menopause, the Department of Health and Human Services announced on Monday.
During menopause, the ovaries stop making high levels of estrogen. HRT products are designed to replace the hormones that the body isn’t making enough of, according to the Cleveland Clinic. This can help reduce symptoms like hot flashes, vaginal dryness, insomnia and bone loss.
However, during the early 2000s, a Women’s Health Initiative study on HRT products found a “statistically non-significant increase in the risk of breast cancer diagnosis,” leading to the FDA applying black box warnings on HRT products, according to HHS’ announcement. Black box warnings are issued to drugs that may cause serious harm or death. Participants in the study were given a hormone formulation that was not commonly used. In addition, the average age of participants was 63 years, which is more than a decade over the average age of women experiencing menopause.
HHS said the FDA is removing the black box warnings after a “comprehensive review” of scientific literature, an expert panel held in July and a public comment period. The agency will work with companies to eliminate references to risks of cardiovascular disease, breast cancer and dementia on the labels.
“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” said Robert F. Kennedy Jr., HHS secretary, in a statement. “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”
Studies show that starting HRT within 10 years of the onset of menopause, usually before age 60, can lower a woman’s risk of all-cause mortality and fractures. It may also reduce the chances of heart disease by up to 50%, Alzheimer’s by 35% and bone fractures by more than 50%.
HHS also announced that the FDA is approving two new drugs for menopause. This includes a generic version of Premarin (an HRT product), as well as a non-hormonal treatment for those who can’t use hormone therapy.
An executive at Carrot Fertility, a fertility and family-building company, applauded HHS’ announcement. The company launched a menopause and midlife health clinic in February and offers access to HRT products if considered appropriate.
“For nearly 15 years, this misleading label has prevented a generation of women from receiving the critical care they need before and during menopause,” said Dr. Asima Ahmad, the co-founder and chief medical officer of Carrot. “This has resulted in poorer physical health, emotional well-being and lost productivity at work — just as many women hit major career peaks and milestones. The data is clear — when prescribed and monitored appropriately, hormone therapy can significantly improve the experience of going through midlife transitions.”
Photo: Getty Images, Sarah Silbiger
