Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial

Gideon Koren*, Shannon Clark, Gary D.V. Hankins, Steve N. Caritis, Jason G. Umans, Menachem Miodovnik, Donald R. Mattison, Ilan Matok

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

22 Scopus citations

Abstract

Background: Nausea and vomiting of pregnancy (NVP) is the most common medical condition in pregnancy, affecting up to 80% of expecting mothers. In April 2013 the FDA approved the delayed release combination of doxylamine succinate and -pyridoxine hydrochloride (Diclegis®) for NVP, following a phase 3 randomized trial in pregnant women. The fetal safety of this medication has been proven by numerous studies. However, because it is the only FDA-approved medication for NVP that is likely to be used by a large number of pregnant women, its maternal safety is an important public health question. The Objective is to evaluate the maternal safety of doxylamine succinate -pyridoxine hydrochloride delayed-release preparation (Diclegis® as compared to placebo. Methods: We randomized women suffering from NVP to receive Diclegis® (n = 131) or placebo (n = 125) for 14 days at doses ranging from 2-4 tablets a day, based on a pre-specified titration protocol response to symptoms. Adverse events were collected through patient diaries, clinical examination and laboratory testing. Results: Doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg use was not associated with an increased rate of any adverse event over placebo, including CNS depression, gastrointestinal or cardiovascular involvement. Conclusions: Doxylamine succinate-pyridoxine hydrochloride delayed release combination is safe and well tolerated by pregnant women when used in the recommended dose of up to 4 tablets daily in treating nausea and vomiting of pregnancy. Trial Registration: Clinical Trial Registration No: NCT00614445.

Original languageAmerican English
Article number59
JournalBMC Pregnancy and Childbirth
Volume15
Issue number1
DOIs
StatePublished - 18 Mar 2015

Bibliographical note

Funding Information:
GK has served as a paid consultant of Duchesnay Inc. The study was sponsored by Duchesnay Inc., Blainville, Quebec.

Publisher Copyright:
© Koren et al.

Keywords

  • Diclegis
  • Doxylamine
  • Nausea and vomiting of pregnancy
  • Pyridoxine
  • Safety
  • Toxicology

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