A panel of experts selected by the commissioner of the Food and Drug Administration (FDA) has unanimously recommended that the agency remove the boxed warning on hormone replacement treatments for menopause. Commissioner Dr. Marty Makary gathered the panel of 12 experts to “separate medical dogma from evidence.”
According to MedPage Today. Makary pointed out that when women begin taking estrogen or a combination of estrogen and progesterone within 10 years of the onset of menopause, they have a 25% to 50% reduced risk of suffering a fatal heart attack and cardiovascular disease.
The boxed warning, which includes increased risk of endometrial and breast cancers, dementia, blood clots and stroke, on hormone replacement medication may have discouraged women from trying the medication, said the panel. These warnings are based on findings from the Women’s Health Initiative (WHI) in 2002 that showed hormone therapy increased the risk for these conditions.
However, recently, experts like the FDA panel, the American College of Obstetricians and Gynecologists and the Menopause Society have recommended that the warning label be removed based on new scientific evidence. They argue that the risks were overstated and that the evidence was weighted toward women over the age of 60 when the average age of menopause is 51.
According to Axios, the boxed warning, formerly called a “black box” warning, is an example of “groupthink” according to Makary, who says it has caused unnecessary harm. A study in the journal JAMA last year found that the benefits of hormone therapy far outweigh the risks.
The FDA’s panel of experts last week also discussed the significant difference between using vaginal estrogen creams and gels versus taking pills. “Vaginal or local estrogen is categorically safe for all women ─ period ─ because it does not travel systemically, said Dr. Heather Hirsch, an internist and expert on menopause who served on the panel. She added, “There again, are no increased risks of heart attacks, clots or strokes, and the black box warning is wrong.”
But critics warn that the FDA panel had financial incentives to ask for the removal of the warnings, said the New York Times, as several of the providers consult for pharmaceutical companies or make money from these medications. And Dr. Adriane Fugh-Berman, professor of pharmacology and physiology at Georgetown University Medical Center, noted that the panelists relied mainly on observational studies and downplayed the potentially harmful side effects.
The FDA panel’s recommendation represents a significant shift in the evaluation of hormone therapy safety, challenging the decades-old boxed warning. The agency will now consider this advice alongside ongoing scientific debate and criticism regarding both potential benefits and risks.
Lynn C. Allison ✉
Lynn C. Allison, a Newsmax health reporter, is an award-winning medical journalist and author of more than 30 self-help books.