The period from onset to peak severity of NVP (from 8 to 10 weeks’ gestation) 6 overlaps with the period of fetal organogenesis (from 4 to 10 weeks’ gestation). The fear of potential teratogenicity necessitates a proven safe pharmacologic intervention for NVP during the vulnerable period of organogenesis. Some cases of hyperemesis gravidarum may by avoided by aggressive early treatment of NVP. 7, 8 Approximately 1% of pregnant women develop a severe form of NVP called hyperemesis gravidarum with dehydration, weight loss, and ketonuria. 6 Although NVP is generally considered part of a healthy pregnancy, the potential negative effect on the pregnant woman’s quality of life is significant. 5 In another study, about 25% of women had nausea alone, and 50% had both nausea and vomiting. 5 Only 50% of women experienced relief by 14 weeks’ gestation 90% of those affected had relief by 22 weeks’ gestation. It is colloquially referred to as “morning sickness”, but in one study only 1.8% of women reported nausea limited to mornings alone, whereas 80% reported nausea lasting all day. 2 Estimates of prevalence and economic burden due to NVP are similarly high in developing countries. 1 A recent estimate of the total economic burden in the US in 2012, including drug treatments for mild-to-severe NVP, hospitalizations for hyperemesis gravidarum, time lost from work, and caregiver time, is $1.7 billion. A recent estimate of the prevalence of NVP in the US is 70%. Nausea and vomiting in pregnancy (NVP) is common. In the hierarchical approach to pharmacological treatment of NVP, the combination of doxylamine and pyridoxine should thus be first-tier. 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. 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. This review addresses the historical context, safety, efficacy, pharmacology, and practical role of doxylamine and pyridoxine for the management of NVP. Diclegis is currently the only medication that is FDA-approved for the indication of NVP. In April 2013, the US Food and Drug Administration (FDA) approved doxylamine succinate 10 mg and pyridoxine hydrochloride (a vitamin B 6 analog) 10 mg as a delayed-release combination pill called Diclegis for the treatment of NVP. 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.
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