
一些专家对“缺乏透明度”表示担忧,因为该机构取消了三种雌激素贴片的警告。美国食品药品监督管理局(FDA)官员周五表示,又有三种用于治疗更年期的贴片将不再带有关于心血管疾病、乳腺癌和痴呆症的“黑框警告”。
Some experts express concern about ‘lack of transparency’ as agency removes warnings on three estrogen patches Three more patches for treating menopause will no longer carry black-box warnings about cardiovascular disease, breast cancer and dementia, officials at the US Food and Drug Administration (FDA) said on Friday.
FDA没有召集顾问委员会,并在新闻发布会上几乎没有提供有关该决定科学依据的细节。此前,由于全美患者正面临贴片短缺的困境,FDA已于2月份取消了六种更年期治疗药物的“黑框警告”。
The FDA did not convene an advisory committee and offered few details on the scientific basis for the decision in the press briefing. The news follows the removal of black-box warnings from six menopause treatments in February, as patients across the US struggle with shortages of the patches.