美国食品和药物管理局删除了更年期HRT的黑盒警告, 引用了最新证据, 风险被夸大了. FDA removes black box warnings from menopause HRT, citing updated evidence.

美国食品和药物管理局正在取消绝经期激素替代疗法(HRT)的黑盒警告,援引最新的科学证据,根据过时的研究,先前的风险(如乳腺癌、心脏病和痴呆症)被夸大。 The U.S. FDA will remove black box warnings from menopause hormone replacement therapies, stating that earlier risks such as breast cancer, heart disease, and dementia were overstated due to outdated studies. 这项变化将在几个月内生效,适用于治疗热,夜间出汗和骨质损失的仅用雌激素和组合疗法,并强调针对60岁以下或更年期10年内女性的个性化治疗. The revision, effective in the coming months, applies to both estrogen-only and combination treatments used for hot flashes, night sweats, and bone loss. 虽然对某些产品仍然存在关于子宫内膜癌的警告, FDA表示, The agency emphasized that HRT is safe and effective for most women under 60 or within 10 years of menopause when used appropriately. 这项行动得到卫生官员和医疗团体的支持,旨在减少恐惧,改善获得服务的机会,尽管一些专家敦促审查过程增加透明度。 A warning about endometrial cancer will remain for certain formulations. 该机构还核准了一个通用版的Premarin和一个新的非沿海热闪光治疗方案。 Health officials welcomed the move as a step toward reducing stigma and improving access, while some experts called for continued transparency in reviewing long-term safety data.