TY  - BOOK
AU  - Miodovnik, Menachem
AU  - Umans, Jason G
TI  - Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial
SN  - 1471-2393
PY  - 2015///
KW  - *Dicyclomine
KW  - *Doxylamine
KW  - *Nausea
KW  - *Pregnancy Complications/dt [Drug Therapy]
KW  - *Pyridoxine
KW  - *Vomiting
KW  - Adult
KW  - Antiemetics/ad [Administration & Dosage]
KW  - Antiemetics/ae [Adverse Effects]
KW  - Delayed-Action Preparations/ad [Administration & Dosage]
KW  - Delayed-Action Preparations/ae [Adverse Effects]
KW  - Dicyclomine/ad [Administration & Dosage]
KW  - Dicyclomine/ae [Adverse Effects]
KW  - Double-Blind Method
KW  - Doxylamine/ad [Administration & Dosage]
KW  - Doxylamine/ae [Adverse Effects]
KW  - Drug Combinations
KW  - Drug Monitoring/mt [Methods]
KW  - Female
KW  - Histamine H1 Antagonists/ad [Administration & Dosage]
KW  - Histamine H1 Antagonists/ae [Adverse Effects]
KW  - Humans
KW  - Nausea/dt [Drug Therapy]
KW  - Nausea/et [Etiology]
KW  - Pregnancy
KW  - Pyridoxine/ad [Administration & Dosage]
KW  - Pyridoxine/ae [Adverse Effects]
KW  - Treatment Outcome
KW  - Vitamin B Complex
KW  - Vomiting/dt [Drug Therapy]
KW  - Vomiting/et [Etiology]
KW  - MedStar Health Research Institute
KW  - Journal Article
KW  - Multicenter Study
KW  - Randomized Controlled Trial
KW  - Research Support, Non-U.S. Gov't
N1  - Available online from MWHC library: 2001 - present
N2  - 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; 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; 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
UR  - http://dx.doi.org/10.1186/s12884-015-0488-1
ER  -