美国食品和药物管理局审查SSRI怀孕警告请愿书,
FDA reviews SSRI pregnancy warning petition amid conflict-of-interest concerns.
美国食品和药物管理局正在审查一项公民请愿书, 要求对SSRI进行更强烈的怀孕警告, 理由是可能造成流产和发育问题等潜在风险,
The FDA is reviewing a citizen petition calling for stronger pregnancy warnings on SSRIs, citing potential risks like miscarriage and developmental issues, amid controversy over top regulator Dr. Tracy Beth Hoeg’s close ties to the petition’s author, Dr. Adam Urato.
Hoeg以前没有政府经验,对公共卫生措施持怀疑态度,据报他试图任命Urato为高级顾问,同时提出请愿,引起利益冲突问题。
Hoeg, who has no prior government experience and is known for skepticism of public health measures, is reportedly seeking to appoint Urato as a senior adviser while advancing the petition, raising conflict-of-interest concerns.
批评者警告警告这些警告可能会阻止孕妇接受必要的药物治疗,从而有可能因未经治疗的抑郁症而受到伤害。
Critics warn the warnings could deter pregnant women from taking necessary medication, risking harm from untreated depression.
美国食品和药物管理局必须以书面形式作出回应,
The FDA is legally required to respond in writing, and the Department of Health and Human Services confirmed the agency will address the petition directly.
一项更正澄清说,参加7月会议的9名而非10名专家是批评者,乌拉托被要求担任高级顾问,而不是全职雇员。
A correction clarified that nine, not ten, experts at a July meeting were critics, and Urato was sought as a senior adviser, not a full-time employee.