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 Monday.
During menopause, the ovaries stop producing high levels of estrogen. HRT products are designed to replace hormones that the body does not produce in sufficient quantities, according to the Cleveland Clinic. This can help reduce symptoms such as hot flashes, vaginal dryness, insomnia, and bone loss.
However, in 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 the FDA to apply black box warnings on HRT products, according to the HHS announcement. Black box warnings are issued for drugs that can cause serious harm or death. Study participants were given a hormonal formulation that was not commonly used. Additionally, the average age of the participants was 63 years old, more than a decade above the average age of women experiencing menopause.
HHS said the FDA is removing the black box warnings after a “comprehensive review” of the scientific literature, an expert panel held in July, and a public comment period. The agency will work with companies to remove references to risks of cardiovascular disease, breast cancer and dementia on labels.
“Today, we advocate for all women experiencing menopausal symptoms and seek to learn about their options and receive potentially life-changing treatment,” HHS Secretary Robert F. Kennedy Jr. said in a statement.. “For more than two decades, bad science and bureaucratic inertia have resulted in women and doctors having an incomplete view of HRT. We are returning to evidence-based medicine and giving women again control over their health.”
Studies show that starting HRT within 10 years of the onset of menopause, usually before age 60, can reduce a woman’s risk of fractures and all-cause mortality. It can 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 menopause medications. This includes a generic version of Premarin (a HRT product), as well as a non-hormonal treatment for those who cannot use hormone therapy.
An executive at Carrot Fertility, a fertility and family-building company, applauded the HHS announcement. The company opened a menopause and midlife health clinic in February and offers access to HRT products if deemed 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, co-founder and chief medical officer of Carrot. “This has resulted in poorer physical health, emotional well-being, and loss of productivity at work, just as many women reach important career peaks and milestones. The data is clear: when properly prescribed and monitored, hormone therapy can significantly improve the experience of navigating midlife transitions.”
Photo: Getty Images, Sarah Silbiger