The FDA is removing its strictest safety warnings from hormone replacement therapy for menopause treatment.
announced on Monday that his agency is deregulating hormone replacement therapies for menopause patients by calling for manufacturers to remove black box warnings from their products. Black box warnings are the highest level of caution that the FDA requires for certain potentially dangerous products.
Makary, in an opinion piece in the, cited several studies touting the benefits of hormone replacement therapy and demonstrating a lack of correlation between HRT and dangerous outcomes such as breast cancer.Texas asks court to block Tylenol maker from paying shareholders after filing lawsuit “These are the strongest drug warning the agency can require, and they have inappropriately scared women off from this life-changing, and sometimes life-saving, treatment,” Makary wrote. HRT for menopause consists of estrogen and progesterone, or solely estrogen for women who have undergone a hysterectomy. Evidence suggests that HRT alleviates the short-term symptoms of menopause, from hot flashes and night sweats to weight gain. It can also have significant long-term benefits, including slowing cognitive decline and preventing osteoporosis, the leading cause of disability and death in older women. “In my professional opinion, the demonization of hormone replacement therapy for perimenopausal women and the underappreciation of its health benefits ranks among the greatest mistakes of modern medicine,” Makary wrote Monday.on the risks and benefits of HRT, in particular the risks of breast and uterine cancer, as well as cardiovascular risks. The association between HRT and cancer became what Makary characterized in his op-ed as “groupthink” in 2002, when evidence from the Women’s Health Initiative found a correlation between nonfatal breast cancer and women receiving HRT treatment. Eventually, this led to the FDA putting a black box warning on HRT menopause treatments in 2003. “Even though the 2002 Women’s Health Initiative finding on nonfatal breast cancer wasn’t statistically significant, it triggered a media frenzy and led the public to view HRT as a carcinogen rather than a lifesaving medication,” Makary wrote.GOP DEMANDS ANSWERS FROM FDA ON ABORTION PILL APPROVAL Proponents of the black box warning argue that the label sparks important conversations about risk-benefit between patient and provider, but Makary and those supportive of liberating HRT contend that the label does more harm than good by discouraging primary care providers from providing the treatment to patients. “Breaking up groupthink is never easy. But the FDA’s removal of the black box warning against HRT is an important step toward treating menopause with the same scientific rigor we use in other areas of medicine,” Makary wrote.
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