FDA启动移除更年期激素疗法黑框警告，心血管疾病、乳腺癌与痴呆表述将删，子宫内膜癌警告保留
美国卫生与公众服务部（HHS）11月10日宣布，美国食品药品管理局（FDA）正在启动程序，移除更年期激素替代疗法（HRT）产品上沿用多年的宽泛「黑框」警告。FDA表示，此举是在全面审查科学文献、今年7月举行专家小组会议并经过公众意见征询期之后作出的。
具体调整方面，FDA正与相关企业合作更新产品标签，删除其中涉及心血管疾病、乳腺癌和可能痴呆风险的表述；但对于全身性单用雌激素产品，FDA不寻求移除关于子宫内膜癌的黑框警告。FDA在发布中回顾称，相关警告源于「妇女健康倡议」研究，该研究参与者平均年龄为63岁，比女性平均绝经年龄高出十多岁，且受试者使用的激素配方如今已不常用。
FDA同时公布两项新批准：一是批准了Premarin（结合雌激素）的一款仿制药，为30多年来该广泛使用疗法的首款仿制药获批；二是批准一款用于治疗更年期中重度血管舒缩症状（如潮热）的非激素治疗药物。FDA表示，其标签建议为：全身性激素疗法应在绝经开始后10年内或60岁之前开始；发布中引用的随机研究显示，在这一时间窗内开始治疗与全因死亡率和骨折风险下降相关。上述内容均为FDA与HHS在发布中的官方表述，具体用药决定由处方医生与患者共同作出。
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.
来源：美国食品药品管理局
发布：GSM·美国（发布链接）
图片来源：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。
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