Carey Jennifer L, Nader Nathalie, Chai Peter R, Carreiro Stephanie, Griswold Matthew K, Boyle Katherine L
Division of Medical Toxicology, Department of Emergency Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.
Division of Medical Toxicology, Department of Emergency Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.
Clin Ther. 2017 Jan;39(1):10-22. doi: 10.1016/j.clinthera.2016.12.009. Epub 2017 Jan 7.
A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women.
在过去40年里，美国食品药品监督管理局从市场上撤下的大量药物和医疗器械，尤其给女性带来了更大的健康风险。本文回顾了临床研究政策中性别因素的历史背景，并描述了几种已获批用于女性的药物和器械，它们已导致了重大的发病和死亡情况。还讨论了这些药物和器械的目标人群、受影响人群、审批过程，以及针对制药/器械公司采取的基本和法律行动。人们认识到，女性仍然面临着来自不安全药物和器械的伤害风险，而促进将性别因素纳入研究设计和分析的立法的持续完善，将提高男性和女性的安全性。
