The U.S. Department of Health and Human Services announced Monday that the U.S. Food and Drug Administration will remove black box warnings on hormone replacement therapy (HRT) products, which are commonly used to treat menopause.
During menopause, the ovaries stop producing high levels of estrogen. According to the Cleveland Clinic, hormone replacement therapy products are designed to replace hormones that the body is not producing enough. This can help reduce symptoms such as hot flashes, vaginal dryness, insomnia, and bone loss.
However, in the early 2000s, a study of HRT products conducted by the Women's Health Initiative found “no statistically significant increased risk of breast cancer diagnosis,” leading the FDA to apply a black box warning to HRT products, according to an HHS announcement. A black box warning is issued for drugs that may cause serious injury or death. Study participants received a less commonly used hormone preparation. Additionally, the average age of participants was 63, more than a decade older than the average age of menopausal women.
HHS said the FDA is removing the black box warning after a “comprehensive review” of the scientific literature, an expert panel convened in July and a public comment period. The agency will work with companies to remove references to cardiovascular disease, breast cancer and dementia risks from labels.
“Today, we stand up for every woman experiencing menopausal symptoms who wants to know her options and receive potentially life-changing treatment,” U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. said in a statement.. “For more than two decades, bad science and bureaucratic inertia have left women and doctors with an incomplete view of HRT. We are returning to evidence-based medicine to put women in control of their health again.”
Studies show that starting HRT within 10 years of the onset of menopause (usually before age 60) reduces a woman's risk of all-cause mortality and fractures. It can also reduce the chance of heart disease by up to 50%, Alzheimer's disease by 35%, and fractures by more than 50%.
HHS also announced that the FDA is approving two new drugs to treat menopause. This includes generic versions of Premarin, an HRT product, as well as non-hormonal treatments for patients who cannot use hormone therapy.
An executive at fertility and home-building company Carrot Fertility applauded HHS's announcement. The company launched menopause and midlife health clinics in February and offers HRT products where it sees fit.
“For nearly 15 years, this misleading label has prevented a generation of women from getting the critical care they need before and during menopause,” said Dr. Asima Ahmad, co-founder and chief medical officer of Carrot. “This has led to worsening physical health, emotional well-being, and decreased productivity at work – just as many women reach the peak and milestones of their careers. The data is clear – when prescribed and monitored appropriately, hormone therapy can significantly improve the experience of the midlife transition.”
Photo: Getty Images, Sarah Silbig
