Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
Am J Obstet Gynecol. 2021 Jul;225(1):21-32. doi: 10.1016/j.ajog.2021.02.032.
Obstetrical healthcare providers frequently field questions about the safety of medications recommended or prescribed to their pregnant patients. Most women use as least 1 medication during pregnancy; however, there is little information about the safety or appropriate dosing of many medications during this phase of life. In addition, the development of drugs for use in pregnant women trails behind the development of drugs intended for other sectors of the population. Our goal is to inform the obstetrics community about the US Food and Drug Administration authority and their role in approving drugs for marketing. We begin with the statutes that led to the creation of the Food and Drug Administration and its current organization. We then cover drug development and the Food and Drug Administration review process, including the role of the advisory committee. The different types of drug approvals are discussed, with some specific examples. Finally, we enumerate the drugs specifically approved for use in obstetrics and contrast them with drugs commonly used by pregnant women and drugs used "off-label" during pregnancy. The Food and Drug Administration is committed to protecting and advancing the public health of pregnant women by guiding the development and ensuring the availability of effective and safe therapeutics for obstetrical indications and for medical conditions during pregnancy. We hope this review will inspire more research addressing drug use during pregnancy.
产科医疗服务提供者经常会被问到他们为孕妇推荐或开的药物的安全性问题。大多数女性在怀孕期间至少使用一种药物；然而，关于许多药物在这个生命阶段的安全性或适当剂量的信息却很少。此外，用于孕妇的药物的开发落后于用于人口其他部分的药物的开发。我们的目标是让产科界了解美国食品和药物管理局的权威及其在批准药物上市方面的作用。我们首先介绍了导致食品和药物管理局成立及其现有组织的法规。然后我们介绍了药物开发和食品和药物管理局审查过程，包括顾问委员会的作用。讨论了不同类型的药物批准，并举例说明。最后，我们列举了专门批准用于产科的药物，并将其与孕妇常用的药物和怀孕期间“超说明书”使用的药物进行对比。食品和药物管理局致力于通过指导药物开发和确保为产科适应症和妊娠期间的医疗状况提供有效和安全的治疗药物，保护和促进孕妇的公共卫生。我们希望这篇综述能激发更多关于孕妇用药的研究。
