Prescription medications for use in pregnancy-perspective from the US Food and Drug Administration.
Am J Obstet Gynecol
; 225(1): 21-32, 2021 07.
Article
em En
| MEDLINE
| ID: mdl-34215352
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.
Palavras-chave
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
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
United States Food and Drug Administration
/
Gravidez
/
Aprovação de Drogas
/
Medicamentos sob Prescrição
Tipo de estudo:
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Animals
/
Female
/
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Am J Obstet Gynecol
Ano de publicação:
2021
Tipo de documento:
Article