"The prominent warnings said these therapies could raise the risks for some cancers, dementia, heart attacks and strokes. That, FDA Commissioner Marty Makary told CBS News' Norah O'Donnell, scared women from using drugs that could in fact improve their health. "We now have a more nuanced understanding, and we want to put that fear machine in its proper context and let people know that there are tremendous long-term health benefits," Makary said."
"The FDA convened an expert panel in July to discuss removing them from at least low-dose vaginal estrogen. The agency then opened a docket to solicit comments from the public and received nearly 3,000 by the Sept. 24 deadline. In its formal comment, the American College of Obstetrics and Gynecology, or ACOG, wrote that it has "long encouraged" the agency to reevaluate warning labels on low-dose estrogen products administered vaginally, but it considers those separate from systemic estrogen products."
FDA is removing black box safety warnings from all hormone therapy creams, pills and other treatments for menopause and perimenopause. The warnings said these therapies could increase risks of some cancers, dementia, heart attacks and strokes. FDA Commissioner Marty Makary said fear of those warnings deterred women from using beneficial drugs and emphasized updated understanding and long-term health benefits. The agency convened an expert panel, opened a public docket and received nearly 3,000 comments. ACOG urged reevaluation for low-dose vaginal estrogen but distinguished systemic estrogen. The 2002 Women's Health Initiative raised concerns; later research showed risks were overstated and benefits may include reduced heart disease when therapy begins earlier. Some doctors criticized the panel's process.
Read at www.npr.org
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