FDA Removes Warning Label from Hormone Therapy for Menopause
The Food and Drug Administration (FDA) announced on Monday that hormone therapies for menopause will no longer carry a black box warning regarding serious risks, including breast cancer, heart attack, and stroke. This significant change comes after a thorough review of current scientific evidence, which FDA officials believe shows that the previous warnings were based on outdated research.
In a press conference, FDA Commissioner Marty Makary stated, “We are going to stop the fear machine steering women away from this life changing, even life saving, treatment.” The decision aims to encourage women to consider hormone therapy, which is commonly prescribed to alleviate symptoms of menopause such as hot flashes, mood swings, and sleep difficulties. These therapies replace estrogen and progesterone—hormones that naturally decline during menopause—and are available in various forms, including pills, patches, gels, and creams.
Outdated Warnings and Recent Research
The warning labels were initially introduced following a 2002 clinical trial that halted due to a detected increase in health risks among women undergoing hormone therapy. However, critics argue that this trial was biased, focusing mainly on older women in their 60s and 70s, while many women typically begin hormone therapy in their 40s or 50s. Recent studies have not found the same level of risk associated with the current formulations of hormone therapy.
In an editorial published in the medical journal JAMA, Makary and three other FDA officials noted that the removal of these warnings applies to products containing only estrogen or progestogen, as well as those combining both. They emphasized the overall benefits of hormone therapy, stating, “With the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy.”
Many healthcare professionals have echoed this sentiment. Dr. MargEva Cole, an obstetrician-gynecologist at Duke University School of Medicine, expressed concern that the black box warning discouraged women who might benefit from the treatment. She noted that many patients felt dissuaded after reading the warning, even after being initially excited about starting therapy.
Future of Hormone Therapy
While the black box warnings will be removed, the FDA will still include information about potential risks on product inserts. Additionally, the agency is encouraging the initiation of hormone therapy for women under 60 or within 10 years of the onset of menopause, when symptoms are usually most severe.
In a related development, the FDA also announced the approval of two new medications for menopause symptoms: a generic mixture of estrogen hormones and a non-hormonal treatment designed for moderate to severe hot flashes.
During a panel discussion convened by the FDA in July, proponents of hormone replacement therapy highlighted its potential benefits, including the reduction of cognitive decline and the risk of Alzheimer’s disease, though they acknowledged that more research is necessary.
The impact of these changes is already being felt by women like Beaux Abington, a 51-year-old resident of Florida. Abington, who began experiencing mood swings at age 48, struggled to find a doctor willing to prescribe her hormone therapy. After being treated at an anti-aging clinic, she reported significant improvements in her mental well-being, saying, “It just was like all of the parts of my brain coming alive again.”
The FDA’s decision to remove the warning label marks a pivotal moment in the conversation around menopause treatment, aiming to provide women with clearer information and access to potentially life-enhancing therapies.
