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Doxylamine succinate–pyridoxine hydrochloride (Diclegis) for the management of nausea and vomiting in pregnancy: an overview

Authors Nuangchamnong N, Niebyl J

Received 22 November 2013

Accepted for publication 4 February 2014

Published 12 April 2014 Volume 2014:6 Pages 401—409


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 4

Nina Nuangchamnong, Jennifer Niebyl

Department of Obstetrics and Gynecology, University of Iowa Hospitals and Clinics, Iowa, IA, USA

Abstract: Nausea and vomiting in pregnancy (NVP) is common and often undertreated, in part due to fears of adverse effects of medications on the fetus during early pregnancy. In April 2013, the US Food and Drug Administration (FDA) approved doxylamine succinate 10 mg and pyridoxine hydrochloride (a vitamin B6 analog) 10 mg as a delayed-release combination pill called Diclegis for the treatment of NVP. Diclegis is currently the only medication that is FDA-approved for the indication of NVP. This review addresses the historical context, safety, efficacy, pharmacology, and practical role of doxylamine and pyridoxine for the management of NVP. The reintroduction of this doxylamine–pyridoxine combination pill into the American market fills a therapeutic gap in the management of NVP left by the removal of the same active drugs marketed over 30 years ago in the form of Bendectin. The substantial amount of safety data accumulated over the years makes it one of the few drugs that qualify for FDA Pregnancy Category A status. In the hierarchical approach to pharmacological treatment of NVP, the combination of doxylamine and pyridoxine should thus be first-tier.

Keywords: doxylamine, pyridoxine, vitamin B6, nausea, vomiting, pregnancy

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