林业发展局正在审查一份请愿书,以便在抗抑郁剂中增加怀孕风险警告,引起对利益冲突和证据薄弱的关切。
The FDA is reviewing a petition to add pregnancy risk warnings to antidepressants, sparking concerns over conflict of interest and weak evidence.
FDA正在审查一项请愿,要求在抗抑郁药如SSRIs中添加带有框框的警告,内容涉及潜在的妊娠风险,包括流产和胎儿脑部异常,这一举措由母胎医学专家亚当·乌拉托博士领导。
The FDA is reviewing a petition to add a boxed warning to antidepressants like SSRIs over potential pregnancy risks, including miscarriage and fetal brain abnormalities, a move led by maternal-fetal medicine specialist Dr. Adam Urato.
FDA最高药品监管官特雷西·贝丝·霍格博士正在推进请愿,同时据报道正努力聘用乌拉托,这引发了利益冲突的担忧。
Dr. Tracy Beth Hoeg, the FDA’s top drug regulator, is advancing the petition while reportedly working to hire Urato, raising conflict-of-interest concerns.
批评者说,主要以动物研究和小型人类试验为基础的证据很薄弱,可能使孕妇不愿接受必要的药物治疗,从而有可能受到未经治疗的抑郁症的伤害。
Critics say the evidence—based largely on animal studies and small human trials—is weak and could discourage pregnant women from taking necessary medication, risking harm from untreated depression.
Hoeg先前没有政府经验, 质疑公共卫生措施, 被控将乌拉托的工作视为自己的工作。
Hoeg, who has no prior government experience and has questioned public health measures, has been accused of presenting Urato’s work as her own.
美国食品药品管理局必须以书面形式回应所有公民的请愿,
The FDA must respond in writing to all citizen petitions, and the situation has drawn scrutiny over impartiality in drug safety decisions.