美国监管部门批准的用于核反应堆爆炸和炭病相关生物恐怖主义的药物疗法
Charles L Bennett1, Peter Georgantopoulos1, Robert Peter Gale1
1The SmartState Center for Medication Safety and Efficacy and the Department of Family Medicine, the University of South Carolina, Columbia, South Carolina, (CLB, PG, KK, CN, WJH), the City of Hope National Cancer Institute Designated Comprehensive Cancer Center, Duarte, California (CLB, SJR), Imperial College London (RPG), the University of Nebraska College of Medicine/Omaha Omaha, Nebraska (JOA), Duarte, California (CLB).
Expert opinion on drug safety
|August 18, 2023
概括
美国食品和药物管理局 (FDA) 已批准多种药物用于治疗公共卫生紧急情况,如辐射事件和炭菌生物恐怖主义. 这些包括抗生素,疫苗和支持性护理药物,确保国家准备.
科学领域:
- 公共卫生紧急情况 公共卫生紧急情况
- 放射性事件 放射性事件
- 对生物恐怖主义的准备情况
背景情况:
- 核反应堆事故和生物恐怖主义爆发对公众健康构成重大风险.
- 关于美国食品和药物管理局 (FDA) 批准的用于减轻这些事件的药物的知识有限.
- 美国食品和药物管理局批准的医疗对策对于国家安全和公共卫生弹性至关重要.
研究的目的:
- 审查FDA批准的治疗血液形成性急性辐射综合征 (H-ARS) 的药物.
- 审查FDA批准的药物用于治疗或预防由Bacillus anthracis (炭) 暴露引起的肺部感染.
- 通过编目可用的医疗对策来为公共卫生准备战略提供信息.
主要方法:
- 对FDA批准的药品进行文献搜索.
- 数据来源于药物@FDA数据库 (2001-2023年).
- 专注于批准用于H-ARS和炭病相关紧急情况的药物.
主要成果:
- 已批准用于H-ARS的四种药物:G-CSF,基化G-CSF和罗米普洛斯蒂姆.
- 对于炭:已批准五种抗生素,两种单克隆抗体,一种抗毒素和两种疫苗.
- 许多抗生素和支持性护理剂对常见的感染/癌症和放射性事件有双重批准.
结论:
- 美国食品和药物管理局已经批准了一系列制药产品,以应对严重的公共卫生威胁.
- 一个国家库存系统确保了这些重要的医疗对策的可用性.
- 监管批准为有效应对放射性和生物恐怖主义事件提供了基础.
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