A panel of medical experts called for the removal of warning labels on hormone therapy for menopausal women during a meeting convened Thursday by the Food and Drug Administration.Led by FDA Commissioner Martin Makary, the meeting focused on the benefits and risks of menopause hormone therapy, or MHT, which has become a controversial topic due to mixed study data.The panel, which consisted of 12 experts with various medical backgrounds, took a generally positive view of MHT and described situations in which patients experienced severe symptoms could not get access to treatment.I am begging the FDA, and all of us are begging, please remove the box label, JoAnn Pinkerton, a professor of obstetrics and gynecology at the University of Virginia Health System, said during the meeting.MHT can offer relief from vasomotor symptoms, or hot flashes, in women going through menopause. But its not always prescribed as various versions come with black box warnings indicating an increased risk of cancer and cardiovascular events. Current labeling also warns against using estrogen for the prevention of cardiovascular disease or dementia.Those warnings stem from a major study conducted by the Women's Health Initiative, or WHI, which evaluated the use of estrogen plus progestin in postmenopausal women. The study was stopped early in 2002 after researchers observed an increased risk of breast cancer and heart disease. An arm of the trial arm involving use of estrogen only was also stopped early in 2004 due to an apparent increased risk of stroke.Makary has previously been critical of the warnings on MHT and advocated for its greater use. In his 2024 book Blind Spots and again during Thursdays panel he questioned the evidence showing higher cancer risk and argued that MHT may actually prevent cardiovascular and cognitive diseases.The panelists were generally dismissive of the WHI study and its findings. Many, however, were already on the record holding similar views as Makary on the warning label. Philip Sarrel, an emeritus professor of obstetrics, gynecology and reproductive sciences and psychiatry from the Yale School of Medicine, was quoted in Makarys book, according to The New York Times. Four of the panelists are members of an advocacy group supported in part by Pfizer, Bayer and Astellas called Lets Talk Menopause. The group has called for the removal of the black box warning.During the meeting, Rachel Rubin, an assistant clinical professor in urology at Georgetown University Hospital and an adviser to Lets Talk Menopause, urged the FDA to remove the box label.We're going to take a hard look at that, Makary responded.The meeting Thursday did not set aside time for public participation, but a docket for comments will be open on the Federal Register, an FDA official said.While some experts believe the WHI study overestimated risks, follow-up testing evaluated conjugated equine estrogens alone or in addition to medroxyprogesterone acetate in women aged 50 to 79 years. That data found similar risks including breast cancer, stroke and dementia. Study researchers concluded hormonal therapy should not be used for chronic disease prevention, but is appropriate for symptom management in some women.One of those researchers, Harvard Medical School professor JoAnn Manson, attended the meeting virtually, but had Pinkerton speak for her.Critics of the warnings argue that new formulations of treatments not used in the WHI study, such as vaginal estrogen or low-dose estrogen, might be safer. No similar major trial has evaluated the new formulations.Some medical associations broadly recommend MHT, but caution that there are potential risks and emphasize conversations with physicians.Makary did not indicate what steps, if any, the FDA plans to take next. '