Koren Gideon
Motherisk Program, Department of Pediatrics, The Hospital for Sick Children, and the University of Toronto, Toronto, Canada.
J Popul Ther Clin Pharmacol. 2013;20(2):e161-2. Epub 2013 Jul 14.
The US FDA approval in April 2013 of Diclegis®, the doxylamine-pyridoxine combination for morning sickness, is a major milestone, particularly since it is indicated for use in pregnancy and the FDA has labeled it a pregnancy category A drug the strongest evidence of fetal safety. After thirty years of being orphaned from an FDA-labeled drug for the most common medical condition in pregnancy, American women and their health care providers have a therapeutic solution that is likely to positively impact millions of women each year. This review highlights the milestones of this antiemetic agent over the last 40 years.
2013年4月，美国食品药品监督管理局（FDA）批准了用于治疗孕吐的多西拉敏-吡哆醇复方制剂Diclegis®，这是一个重要的里程碑，特别是因为该药物适用于孕期使用，且FDA已将其列为妊娠A类药物，这是胎儿安全性的最有力证据。在针对孕期最常见病症的FDA批准药物缺失三十年后，美国女性及其医疗服务提供者终于有了一种治疗方案，每年可能对数百万女性产生积极影响。本文综述了这种止吐药物在过去40年中的发展历程。
