title: Doxylamine succinate-pyridoxine hydrochloride (Diclegis) for the management of nausea and vomiting in pregnancy: an overview.
abstract: 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. In April 2013, the US Food and Drug Administration (FDA) approved doxylamine succinate 10 mg and pyridoxine hydrochloride (a vitamin B6 analog) 10 mg as a delayed-release combination pill called Diclegis for the treatment of NVP. Diclegis is currently the only medication that is FDA-approved for the indication of NVP. This review addresses the historical context, safety, efficacy, pharmacology, and practical role of doxylamine and pyridoxine for the management of NVP. 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. 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. In the hierarchical approach to pharmacological treatment of NVP, the combination of doxylamine and pyridoxine should thus be first-tier.
authors.affiliation: Department of Obstetrics and Gynecology, University of Iowa Hospitals and Clinics, Iowa, IA, USA.
authors.forename: Nina
authors.initials: N
authors.lastname: Nuangchamnong
authors.affiliation: Department of Obstetrics and Gynecology, University of Iowa Hospitals and Clinics, Iowa, IA, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Niebyl
keywords: doxylamine; nausea; pregnancy; pyridoxine; vitamin B6; vomiting
references.citation: J Pediatr. 2009 Jul;155(1):45-50, 50.e1-2
references.pmid: 19394042
references.citation: Birth Defects Res A Clin Mol Teratol. 2012 Jan;94(1):22-30
references.pmid: 22102545
references.citation: J Popul Ther Clin Pharmacol. 2013;20(2):e163-70
references.pmid: 23863545
references.citation: PLoS One. 2011;6(11):e27678
references.pmid: 22125621
references.citation: Clin Invest Med. 1999 Jun;22(3):106-10
references.pmid: 10410832
references.citation: Br J Gen Pract. 1993 Jun;43(371):245-8
references.pmid: 8373648
references.citation: Obstet Gynecol. 1991 Jul;78(1):33-6
references.pmid: 2047064
references.citation: Obstet Gynecol. 2010 May;115(5):975-981
references.pmid: 20410771
references.citation: Reprod Toxicol. 1995 Jul-Aug;9(4):337-49
references.pmid: 7496090
references.citation: Teratology. 1994 Jul;50(1):27-37
references.pmid: 7974252
references.citation: Am J Obstet Gynecol. 2010 Dec;203(6):571.e1-7
references.pmid: 20843504
references.citation: Birth Defects Res A Clin Mol Teratol. 2003 Feb;67(2):88-97
references.pmid: 12769504
references.citation: PLoS One. 2013 May 10;8(5):e64214
references.pmid: 23675528
references.citation: Cochrane Database Syst Rev. 2010 Sep 08;(9):CD007575
references.pmid: 20824863
references.citation: Obstet Gynecol. 2004 Apr;103(4):803-14
references.pmid: 15051578
references.citation: JAMA. 2013 Oct 16;310(15):1601-11
references.pmid: 24129464
references.citation: Ther Drug Monit. 2011 Feb;33(1):115-9
references.pmid: 21079545
references.citation: Am J Obstet Gynecol. 1995 Sep;173(3 Pt 1):881-4
references.pmid: 7573262
references.citation: N Engl J Med. 2013 Feb 28;368(9):814-23
references.pmid: 23445092
references.citation: J Clin Pharmacol. 2013 Mar;53(3):334-8
references.pmid: 23444286
references.citation: Am J Obstet Gynecol. 1996 May;174(5):1565-8
references.pmid: 9065130
references.citation: J Obstet Gynaecol Can. 2002 Oct;24(10):817-31; quiz 832-3
references.pmid: 12405123
references.citation: Drug Intell Clin Pharm. 1988 Oct;22(10):813-24
references.pmid: 3229352
references.citation: Teratology. 2000 Dec;62(6):385-92
references.pmid: 11091360
references.citation: J Popul Ther Clin Pharmacol. 2013;20(2):e149-60
references.pmid: 23913638
references.citation: Am J Obstet Gynecol. 2000 Apr;182(4):931-7
references.pmid: 10764476
references.citation: Am J Obstet Gynecol. 2002 May;186(5 Suppl Understanding):S253-5
references.pmid: 12011896
references.citation: Drugs. 2000 Apr;59(4):781-800
references.pmid: 10804035
references.citation: Teratology. 1983 Apr;27(2):277-81
references.pmid: 6346560
references.citation: PLoS One. 2012;7(8):e42333
references.pmid: 22879943
references.citation: Obstet Gynecol Int. 2013;2013:809787
references.pmid: 23476657
references.citation: Women Birth. 2013 Jun;26(2):100-4
references.pmid: 23200815
references.citation: Arch Gynecol Obstet. 1992;251(4):181-5
references.pmid: 1503509
references.citation: N Engl J Med. 2010 Oct 14;363(16):1544-50
references.pmid: 20942670
references.citation: J Clin Pharmacol. 2001 Aug;41(8):842-5
references.pmid: 11504271
references.citation: Pharmacotherapy. 2006 Sep;26(9):1273-87
references.pmid: 16945050
references.citation: Hum Nutr Clin Nutr. 1985 Jan;39(1):75-9
references.pmid: 3997551
references.citation: Isr Med Assoc J. 2013 Jan;15(1):23-6
references.pmid: 23484234