Koren Gideon, et al.
BMC pregnancy and childbirth, 2015
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.
Trial registration
Clinical Trial Registration No: NCT00614445
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.
| PMID: | 25884778 |
|---|---|
| PMCID (Free PMC Article): | PMC4391332 |
| DOI: | 10.1186/s12884-015-0488-1 |
| Category: | Prenatal / Pregnancy |
Articles similar to "Maternal Safety of the Delayed-Release Doxylamine and Pyridoxine Combination for Nausea and Vomiting of Pregnancy; A Randomized Placebo Controlled Trial."
- The role of Pyridoxine Hydrochloride in Prenatal / Pregnancy: Demonstration of Early Efficacy Results of the Delayed-Release Combination of Doxylamine-Pyridoxine for the Treatment of Nausea and Vomiting of Pregnancy. ( Nausea and vomiting of pregnancy (NVP) affects up to 80% of expecting mothers... A four day study drug dosing trial with Diclegis® is sufficient to document efficacy, as the results are similar to those achieved after 14 study drug dosing days. The benefit seen at the earlier time validates drug efficacy and minimizes the natural course of improvement.)