The Food and Drug Administration (FDA) announced on October 23, 2023, that hormone replacement therapies for menopause will no longer carry a black box warning. This significant change comes amid concerns that outdated warnings about serious risks, including breast cancer, heart attack, and stroke, have deterred women from seeking these treatments. According to FDA Commissioner Marty Makary, this decision is based on a thorough review of current scientific evidence.
In a related editorial published in the medical journal JAMA, Makary and other FDA officials stated that the existing warnings are misaligned with the latest findings. The black box warnings will be removed from medications containing estrogen or progestogen, both alone and in combination. These therapies are commonly prescribed to alleviate menopause symptoms such as hot flashes, mood swings, and vaginal dryness.
“We are going to stop the fear machine steering women away from this life-changing, even life-saving, treatment,” Makary said during a press conference. He emphasized that the FDA’s action is rooted in a robust review of recent studies, which indicate that the benefits of hormone therapy often outweigh the potential risks.
Changing Perspectives on Hormone Therapy
The FDA’s announcement marks a pivotal shift in how hormone therapy is perceived. Many healthcare providers have argued that the black box warning has discouraged women from considering these therapies, which can significantly enhance their quality of life. “Our big concern about the black box warning is that a lot of women are excited about walking out the office and then go home and read the black box and then never start it because they get scared,” said Dr. MargEva Cole, an obstetrician-gynecologist at Duke University School of Medicine.
The origins of the black box warning date back to a 2002 clinical trial that was halted after identifying increased risks associated with a specific formulation of progesterone. This trial primarily involved women in their 60s and 70s, whereas hormone therapy is typically initiated in women in their 40s or 50s. Recent studies have not shown the same elevated risks with current hormone therapy formulations, prompting the FDA to reconsider the warnings.
The FDA will also recommend that hormone therapy be initiated in women under the age of 60 or within ten years of the onset of menopause, when symptoms are usually most pronounced. While the black box warning will be removed, package inserts will still include information about potential adverse events.
New Treatments Approved
Alongside the removal of the warnings, the FDA has approved two new drugs aimed at treating menopause symptoms: a generic mix of estrogen hormones and a non-hormonal treatment for moderate to severe hot flashes. This decision reflects the agency’s commitment to enhancing women’s health options during menopause.
During a meeting in July, the FDA convened a panel of experts who support hormone replacement therapy. Makary highlighted the treatment’s potential benefits, including the reduction of cognitive decline and Alzheimer’s risk, although he noted that further research is needed to substantiate these claims.
Women like Beaux Abington, a 51-year-old from Florida, have expressed relief at the FDA’s latest actions. Abington experienced significant mood changes at age 48, which she suspected were related to perimenopause. After facing multiple rejections from healthcare providers, she eventually received hormone therapy from an anti-aging clinic. “I was not in a good place. I couldn’t get out of bed,” she recounted. Following treatment, her mood improved dramatically: “It just was like all of the parts of my brain coming alive again.”
The FDA’s recent announcements signify a broader recognition of the importance of hormone therapy in managing menopause symptoms and improving the overall health outcomes for women. The removal of the black box warning may encourage more women to seek these treatments, thereby enhancing their quality of life during a challenging phase of life.
