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Randomized Controlled Trial
. 2015 Mar 18:15:59.
doi: 10.1186/s12884-015-0488-1.

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

Gideon Koren  1   2   3 , Shannon Clark  4   5 , Gary D V Hankins  6   7 , Steve N Caritis  8   9 , Jason G Umans  10   11 , Menachem Miodovnik  12   13 , Donald R Mattison  14 , Ilan Matok  15   16
Affiliations
Randomized Controlled Trial

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

Gideon Koren et al. BMC Pregnancy Childbirth. .

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 .

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References

    1. Koren G, Bishai R. Nausea and Vomiting of Pregnancy: State of the art, 2000. Toronto: The Motherisk Program; 2000. pp. 5–9.
    1. Arsenault MY, Lane CA, MacKinnon CJ, Bartellas E, Cargill YM, Klein MC, et al. SOGC clinical practice guidelines: the management of nausea and vomiting of pregnancy. J Obstet Gynaecol Can. 2002;24(10):817–31. - PubMed
    1. Koren G, Pastuszak A, Ito S. Drugs in pregnancy. N Engl J Med. 1998;338:1128–37. doi: 10.1056/NEJM199804163381607. - DOI - PubMed
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    1. Federal Register /Vol. 64, No 152/August 9, 1999/Notes, Determination that Bendectin was not withdrawn from sale for reasons of safety or effectiveness.

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