College of Pharmacy, Washington State University, Spokane, Washington, USA.
Clin Pharmacol Ther. 2017 Apr;101(4):430-434. doi: 10.1002/cpt.613.
New drugs were not required to undergo premarket safety testing in the United States until 1938, when a therapeutic disaster-the Elixir Sulfanilamide tragedy-prompted Congress to pass a bill mandating this now-routine process. History repeated itself nearly 25 years later, when another therapeutic disaster-the thalidomide tragedy-led to passage of new amendments in 1962 to ensure drug efficacy and greater drug safety. As is typical with historical events, critical information was gained that led to novel approaches for understanding, predicting, diagnosing, and managing drug-induced toxicities. Continued refinement of current, along with development of new, approaches will mitigate future drug-related catastrophes, with the goal of avoiding them entirely.
新的药物在美国不需要进行上市前的安全测试，直到 1938 年，当时一场治疗灾难——磺胺酏剂悲剧——促使国会通过了一项法案，要求进行这一现在已经成为常规的程序。近 25 年后，历史再次重演，另一场治疗灾难——反应停悲剧——导致 1962 年通过了新的修正案，以确保药物的疗效和更大的药物安全性。与历史事件一样，获得了关键信息，从而为理解、预测、诊断和管理药物引起的毒性提供了新的方法。随着新方法的不断完善，当前的方法也将得到改进，以减轻未来与药物相关的灾难，并完全避免这些灾难。
