Departments of Anesthesiology.
Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA.
J Neurosurg Anesthesiol. 2019 Jan;31(1):129-133. doi: 10.1097/ANA.0000000000000545.
In December 2016, the US Food and Drug Administration (FDA) issued a drug safety warning stating that 11 commonly used anesthetic and sedative medications had potential neurotoxic effects when used in children under the age of 3 years and in pregnant women during the third trimester. A panel presentation at the sixth biennial Pediatric Anesthesia Neurodevelopmental Assessment (PANDA) symposium addressed the FDA announcement in a session entitled "Anesthesia Exposure in Children During Surgical and Non-Surgical Procedures: How Do We Respond to the 2016 FDA Drug Safety Communication?" Panelists included representatives from pediatric anesthesiology, obstetrics, pediatric surgery, and several pediatric surgical subspecialties. Each panelist was asked to address the following questions: How has the FDA labelling change affected your clinical practice including patient discussions, timing, and frequency of procedures? Has your professional society provided any guidelines for this discussion? Has there been any discussion of this topic at your national meetings? The panelists provided important perspectives specific to each specialty, which generated a lively discussion and a detailed response from the Deputy Director of the Division of Anesthesia and Addiction of the FDA describing the FDA procedures that led to this drug safety warning.
2016 年 12 月，美国食品和药物管理局（FDA）发布了一则药物安全警告，称在三岁以下儿童和怀孕晚期（妊娠第三期）的孕妇中使用 11 种常用的麻醉和镇静药物时，可能具有神经毒性作用。在第六届儿科麻醉神经发育评估（PANDA）研讨会的一次小组讨论会上，题为“手术和非手术过程中儿童的麻醉暴露：我们如何应对 2016 年 FDA 药物安全通讯？”的会议中，讨论了 FDA 的这一公告。小组成员包括来自儿科麻醉学、妇产科、儿科外科和几个儿科外科亚专业的代表。每位小组成员都被要求回答以下问题：FDA 的标签变化如何影响您的临床实践，包括患者讨论、手术时间和频率？您的专业协会是否为该讨论提供了任何指南？在您的全国会议上是否讨论过这个话题？小组成员就每个专业的具体情况提供了重要的观点，引发了热烈的讨论，FDA 麻醉和成瘾司副司长详细介绍了 FDA 的程序，这些程序导致了这一药物安全警告。
