Prescription medications for use in pregnancy-perspective from the US Food and Drug Administration

Abstract

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.

Keywords: 17-hydroxyprogesterone caproate; Cervidil; Diclegis; FDA; FDA guidance; FDA regulations; FDA review of drugs; Makena; Methergine; Pitocin; Prepidil; Syntocinon; Yutopar; dinoprostone; doxylamine; drug approval in pregnancy; drugs approved for use in pregnancy; magnesium sulfate; methylergonovine maleate; oxytocin; pyridoxine; ritodrine.