Wax P M
Department of Emergency Medicine, University of Rochester School of Medicine, NY 14642.
Ann Intern Med. 1995 Mar 15;122(6):456-61. doi: 10.7326/0003-4819-122-6-199503150-00009.
The Elixir Sulfanilamide disaster of 1937 was one of the most consequential mass poisonings of the 20th century. This tragedy occurred shortly after the introduction of sulfanilamide, the first sulfa antimicrobial drug, when diethylene glycol was used as the diluent in the formulation of a liquid preparation of sulfanilamide known as Elixir Sulfanilamide. One hundred five patients died from its therapeutic use. Under the existing drug regulations, premarketing toxicity testing was not required. In reaction to this calamity, the U.S. Congress passed the 1938 Federal Food, Drug and Cosmetic Act, which required proof of safety before the release of a new drug. The 1938 law changed the drug focus of the Food and Drug Administration from that of a policing agency primarily concerned with the confiscation of adulterated drugs to a regulatory agency increasingly involved with overseeing the evaluation of new drugs. The Elixir Sulfanilamide tragedy, its effect on drug regulations, and the history of other diethylene glycol and diluent mass poisonings are discussed.
1937年的磺胺酏剂灾难是20世纪最严重的大规模中毒事件之一。这场悲剧发生在第一种磺胺类抗菌药物磺胺问世后不久，当时二甘醇被用作一种名为磺胺酏剂的磺胺液体制剂配方中的稀释剂。105名患者因使用该药物治疗而死亡。根据当时的药品法规，新药上市前无需进行毒性测试。作为对这场灾难的回应，美国国会通过了1938年的《联邦食品、药品和化妆品法案》，该法案要求在新药上市前证明其安全性。1938年的法律改变了美国食品药品监督管理局的药品监管重点，从主要关注没收掺假药品的监管机构转变为越来越多地参与监督新药评估的监管机构。本文讨论了磺胺酏剂悲剧、其对药品法规的影响以及其他二甘醇和稀释剂大规模中毒事件的历史。
