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FDA to Remove “Black Box” Warning from Menopause Hormone Therapy, Citing Outdated Data
The Food and Drug Administration (FDA) announced Monday its decision to remove the prominent “black box” warning from hormone replacement therapy (HRT) products for menopause. This significant change comes more than two decades after early 2000s studies led to the highest warning label being placed on these drugs, causing a substantial drop in their usage.
FDA Commissioner Dr. Marty Makary described the initial placement of the warning as “one of the greatest mistakes in modern medicine – the demonization of hormone replacement therapy.” He estimates that millions of women have avoided HRT due to fears of cancer or heart risks, based on what is now considered an outdated analysis of data.
In recent months, an FDA expert panel conducted a thorough review of the latest scientific studies and ultimately recommended the removal of the warning. Dr. Makary suggested that HRT could “improve the health outcomes of women at a population level more than any other intervention, arguably, with the exception of, say, antibiotics or vaccines.”
A key factor in the reevaluation was the understanding that the timing of when women initiate HRT is critical. Makary highlighted that this “important nuance” was a “design flaw” in the early 2000s studies. Current medical consensus suggests that the benefits of HRT often outweigh potential risks when initiated before age 60 or within 10 years of the onset of menopause.
“This is really the result of doctors waving a flag in the air for decades of women who have said, ‘Hey, we didn’t feel like we got the right information,'” Makary stated. Consumers can expect to see updated labels on HRT products within the next few months.
Federal health officials, including Health and Human Services Secretary Robert F. Kennedy Jr., praised the FDA’s decision during a press conference. Kennedy affirmed that “After a thorough, evidence-based review of decades of scientific data, an expert panel and public testimony, the FDA is announcing today that it will remove the misleading black box warnings from all HRT products.”
The American College of Obstetricians and Gynecologists (ACOG), the largest medical organization of OB-GYNs, also responded positively. Dr. Steven Fleischman, president of ACOG, stated that the label change will “increase access to hormone therapy” and “allow patients and clinicians to engage in a shared decision-making process, without an unnecessary barrier, when it comes to treatment of menopausal symptoms.”
It is important to note that HRT still carries potential risks, and women considering its use should always consult with their doctor, as these medications require a prescription.