FDA to remove warnings on HRT products used for menopause

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 doesn’t produce enough, 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 of HRT products found a “statistically insignificant increase in the risk of breast cancer diagnosis,” leading the FDA to implement black box warnings on HRT products, according to the HHS announcement. Black box warnings are issued for drugs that have the potential to cause serious harm or death. Study participants received a hormonal formulation that was not commonly used. Additionally, the average age of participants was 63, more than a decade older than the average age of postmenopausal women.

HHS said the FDA was 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 eliminate references to the risks of cardiovascular disease, breast cancer and dementia on labels.

“Today, we stand up for every woman experiencing menopausal symptoms who is seeking to learn about her options and receive treatment that could change her life,” Robert F. Kennedy Jr., HHS Secretary, said in a statement.. “For more than two decades, bad science and bureaucratic inertia have led women and doctors to have an incomplete view of HRT. We are returning to evidence-based medicine and putting women in control of their health.”

Studies show that starting HRT within 10 years of the onset of menopause, usually before age 60, can reduce the risk of all-cause mortality and fractures. It can also reduce the risk of heart disease by up to 50%, Alzheimer’s by 35% and bone fractures by more than 50%.

HHS also announced that the FDA approved two new menopause medications. This includes a generic version of Premarin (an 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 launched 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 intensive care they need before and during menopause,” said Dr. Asima Ahmad, co-founder and chief medical officer of Carrot. “This has led to poorer physical health, emotional well-being, and loss of productivity at work – just as many women have reached peaks and milestones in their careers. The data is clear – when prescribed and monitored appropriately, hormone therapy can significantly improve the experience of midlife transitions.”

Photo: Getty Images, Sarah Silbiger