WASHINGTON (AP) — Hormone-based medications used to treat hot flashes and other menopausal symptoms will no longer carry a bold warning label about the risks of stroke, heart attack, dementia and other serious dangers, the U.S. Food and Drug Administration announced on Monday.
Health authorities said they will remove the warning from packaging for boxes containing more than 20 pills, patches, and creams that contain hormones such as estrogen and progestin, which are approved to relieve bothersome symptoms like night sweats.
The move has drawn support from some doctors, including FDA Commissioner Marty Makary, who has described the current label as outdated and unnecessary.
Officials explained the change by pointing to studies suggesting that hormone therapy carries few risks when started before age 60 or within ten years of menopause onset.
“We’re challenging outdated thinking and reaffirming our commitment to evidence-based medicine that empowers rather than restricts,” Health Secretary Robert F. Kennedy Jr. said as he unveiled the update.
The FDA’s warning from 22 years ago warned doctors that hormone therapy may raise the risk of blood clots, heart problems, and other health issues, citing data published more than two decades ago.
Many physicians and pharmaceutical companies have urged removing or revising the label, arguing that it discourages prescriptions and intimidates women who might benefit.
Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said the warnings have created a great deal of doubt among patients.
Other experts have opposed changing the label without a careful and transparent process.
Medical guidelines generally recommend using the medications for a limited period in younger women going through menopause who do not have complex risks, such as breast cancer. The FDA’s updated prescribing information largely aligns with that approach.
But Makary and some other doctors have suggested that the benefits of hormone therapy may extend far beyond simply managing the bothersome symptoms of midlife. Before becoming FDA commissioner, Makary dedicated a chapter in his latest book to praising the broad health benefits of hormone therapy and criticizing physicians who refuse to prescribe it.
On Monday he reiterated that view, citing figures that suggest hormone therapy reduces heart disease, Alzheimer’s disease, and other aging-related conditions.
But the veracity of those benefits remains the subject of ongoing research and debate, even among experts whose work led to the original warning.
Dr. JoAnn Manson of Harvard Medical School said that the evidence of broad health benefits is not “as conclusive or definitive” as Makary described. Still, she noted that removing the warning is a good step because it could lead physicians and patients to make more personalized decisions.
