FDA Begins Removing Boxed Warnings From Menopause Hormone Therapy; Cardiovascular, Breast Cancer and Dementia References to Go, Endometrial Cancer Warning Stays
The U.S. Department of Health and Human Services (HHS) announced on November 10 that the U.S. Food and Drug Administration (FDA) is initiating the removal of broad "black box" warnings from hormone replacement therapy (HRT) products for menopause. The FDA said the action follows a comprehensive review of the scientific literature, an expert panel held in July, and a public comment period.
Under the changes, the FDA is working with companies to update product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia. The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products. In its release, the agency noted that the warnings followed a Women's Health Initiative study whose participants averaged 63 years of age — more than a decade past the average age of menopause — and who received a hormone formulation no longer in common use.
The FDA also announced two approvals: a generic version of Premarin (conjugated estrogens), the first such approval in more than 30 years for the widely used therapy, and a non-hormonal treatment for moderate to severe vasomotor symptoms, such as hot flashes, associated with menopause. The agency said its labeled recommendation will be to start systemic HRT within 10 years of menopause onset or before age 60, and cited randomized studies showing reductions in all-cause mortality and fractures for women who start within that window. The statements above are the FDA's and HHS's own characterizations in their release; treatment decisions are made between prescribers and individual patients.
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: 图中是美国食品药品管理局（FDA）位于马里兰州银泉市白橡树园区的64号楼外景。来源：Wikimedia Commons, Public domain, The U.S. Food and Drug Administration。
