FDA Panel Revisits Hormone Therapy for Menopause
A recent panel of experts convened by the Food and Drug Administration has reignited the discussion surrounding hormone therapy for treating menopause.
Last week, a group of 12 panelists expressed strong support for hormone treatment and urged the FDA to eliminate the “black box” warning associated with such therapies.
“We’re really pleading with the FDA. Please, just remove the black box label,” stated Joan Pinkerton, a panelist and professor at the University of Virginia Health Systems focused on midlife health. She highlighted low-dose vaginal estrogen therapy and emphasized the need to avoid causing harm to women.
The debate among women’s health experts regarding menopause hormone therapy has been ongoing. Some argue that the risks highlighted in the Women’s Health Initiative are overstated, while others maintain that the treatment can pose significant long-term health threats.
“Menopause hormone therapy effectively addresses vasomotor symptoms and vaginal dryness, but those are, well, basically the only well-documented benefits,” noted Barbara Minzes, a pharmacology professor at Georgetown University Medical Center and a professor of pharmaceutical policy at the University of Sydney.
She added that severe adverse effects, like strokes and increased breast cancer risk, are often downplayed or overlooked in current discussions.
Following the publication of the Women’s Health Initiative in 2002, many healthcare providers became hesitant to prescribe hormone therapy for menopause symptoms.
This pivotal longitudinal study observed over 10,000 women in the 1990s to assess estrogen use, and nearly 16,000 undergoing combined estrogen and progestin treatments.
The research was halted when findings indicated a higher risk of invasive breast cancer, strokes, and pulmonary embolism linked to estrogen-progestin regimens, while estrogen alone was associated with an increased stroke risk.
Since then, concerns about estrogen-containing treatments have been voiced, leading to the inclusion of warnings that highlight elevated risks of stroke and dementia. The labeling also advises against using hormones for cardiovascular ailments or dementia treatment.
Critics of the initial study point out that it primarily focused on older women—averaging 63 years old—who were typically well beyond the age when many women first experience menopause.
Advocates like Pinkerton argue that hormone therapy can be very effective when initiated prior to age 60 or within ten years post-menopause.
Another criticism of the study is its focus on a specific type of oral hormone treatment that involved synthetic progesterone, which has not received FDA approval since the study was conducted.
“We know synthetic progestins are linked to a greater risk of breast cancer,” she remarked. “These risks apply not only to hormonal replacement therapy but also potentially to other hormonal methods like IUDs.”
Some authors from the WHI shared insights in a review published last May, suggesting that hormone therapy can be beneficial for certain women.
The review noted that hormone therapy effectively manages “moderate to severe” early menopause symptoms such as hot flashes. This supports the recommendation for initiating hormone therapy prior to age 60 without existing contraindications.
The FDA panel included advocates of menopause hormone therapy, who pointed to various observational studies.
Some critics of the treatment attended the panel and voiced their concerns. An audience member asked FDA commissioner Marty McCurry about public comments, to which he replied that they needed to act quickly, implying there was limited time for discussion.
McCurry has shown a keen interest in menopause hormone therapy, referencing it in his book “Blind Spot” as an illustration of how outdated healthcare notions can harm Americans.
However, he refrained from indicating whether the FDA is preparing to revise the boxed warnings related to menopause hormone therapy. A representative from the Department of Health and Human Services, which oversees the FDA, did not provide insights on possible future adjustments to treatment guidelines.
