Safety considerations surrounding use of treatment options for nausea and vomiting in pregnancy

References

• Lacroix R, Eason E, Melzack R. Nausea and vomiting during pregnancy: a prospective study of its frequency, intensity, and patterns of change. Am J Obstet Gynecol. 2000;182:931–937.
   PubMed Web of Science ®Google Scholar
• London V1, Grube S, Sherer DM, et al. Hyperemesis gravidarum: a review of recent literature. Pharmacology. 2017;100(3–4):161–171.
   PubMed Web of Science ®Google Scholar
• APGO. Nausea and vomiting of pregnancy. APGO Educational series on women’s health issues. Boston: Jespersen & Associates, LLC; 2013.
   Google Scholar
• Goodwin TM. Hyperemesis gravidarum. Obstet Gynecol Clin North Am. 2008;35:401–417.
   PubMed Web of Science ®Google Scholar
• Czeizel AE, Dudas I, Fritz G, et al. The effect of periconceptional multivitamin-mineral supplementation on vertigo, nausea and vomiting in the first trimester of pregnancy. Arch Gynecol Obstet. 1992;251:181–185.
   PubMed Web of Science ®Google Scholar
• Clark SM1, Costantine MM, Hankins GD. Review of NVP and HG and Early Pharmacotherapeutic Intervention. Obstet Gynecol Int. 2012;2012:252676.
   PubMedGoogle Scholar
• Maltepe C, Koren G, Preemptive treatment of nausea and vomiting of pregnancy: results of a randomized controlled trial. Obstet Gynecol Int. 2013; 809787. Epub 2013 Feb 17. 10.1155/2013/809787.
   PubMedGoogle Scholar
• Bottomley C, Bourne T. Management strategies for hyperemesis. Best Pract Res Clin Obstet Gynaecol. 2009;23:549–564.
   PubMed Web of Science ®Google Scholar
• Verberg MF, Gillott DJ, Al-Fardan N, et al. Hyperemesis gravidarum, a literature review. Hum Reprod Update. 2005;11(5):527–539.
   PubMed Web of Science ®Google Scholar
• Jueckstock JK, Kaestner R, Mylonas I. Managing hyperemesis gravidarum: a multimodal challenge. BMC Med. 2010;8:1741–7015.
   Web of Science ®Google Scholar
• Koch KL. Gastrointestinal factors in nausea and vomiting of pregnancy. Am J Obstet Gynecol. 2002;186:S198–203.
   PubMed Web of Science ®Google Scholar
• Koch KL, Frissora CL. Nausea and vomiting during pregnancy. Gastroenterol Clin North Am. 2003;32:201–234.
   PubMed Web of Science ®Google Scholar
• Nguyen P, Einarson A. Managing nausea and vomiting of pregnancy with pharmacological and nonpharmacological treatments. Women’s Health (London, England). 2006;2:753–760.
   PubMedGoogle Scholar
• Gill SK, Maltepe C, Koren G. The effect of heartburn and acid reflux on the severity of nausea and vomiting of pregnancy. Can J Gastroenterol. 2009;23:270–272.
   PubMed Web of Science ®Google Scholar
• Jorgensen KT, Nielsen NM, Pedersen BV. Hyperemesis, gestational hypertensive disorders, pregnancy losses and risks of autoimmune disease in a Danish population –based cohort. J Autoimmun. 2012;38:J 120–8.
   Web of Science ®Google Scholar
• Golberg D, Szilagyi A, Graves L. Hyperemesis gravidarum and Helicobacter pylori infection: a systematic review. Obstet Gynecol. 2007;110:695–703.
   PubMed Web of Science ®Google Scholar
• Sandven I, Abdelnoor M, Nesheim BI, et al. Helicobacter pylori infection and hyperemesis gravidarum: a systematic review and meta-analysis of case–control studies. Acta Obstet Gynecol Scand. 2009;88:1190–1200.
   PubMed Web of Science ®Google Scholar
• Vikanes AV, Stoer NC, Gunnes N, et al. Helicobacter pylori infection and severe hyperemesis gravidarum among immigrant women in Norway: a case–control study. Eur J Obstet Gynecol Reprod Biol. 2013;167:41–46.
   PubMed Web of Science ®Google Scholar
• Sherman PW, Flaxman SM. Nausea and vomiting of pregnancy in an evolutionary perspective. Am J Obstet Gynecol. 2002;186:S190–7.
   PubMed Web of Science ®Google Scholar
• Fejzo MS, Macgibbon KW, Romero R, et al. Recurrence risk of hyperemesis gravidarum. J Midwifery Womens Health. 2011;56:132–136.
   PubMed Web of Science ®Google Scholar
• Fejzo MS, Ingles SA, Wilson M, et al. High prevalence of severe nausea and vomiting of pregnancy and hyperemesis gravidarum among relatives of affected individuals. Eur J Obstet Gynecol Reprod Biol. 2008;141:13–17.
   PubMed Web of Science ®Google Scholar
• Colodro-Conde, L, Jern P, Johansson A, et al. Nausea and vomiting during pregnancy is highly heritable. Behav Genet. 2016 Jul;46(4):481–491.
   PubMed Web of Science ®Google Scholar
• Attard CL, Kohli MA, Coleman S, et al. The burden of illness of severe nausea and vomiting of pregnancy in the United States. Am J Obstet Gynecol. 2002;186:S220–7.
   PubMed Web of Science ®Google Scholar
• Lacasse A, Rey E, Ferreira E, et al. Nausea and vomiting of pregnancy: what about quality of life? BJOG. 2008;115:1484–1493.
   PubMed Web of Science ®Google Scholar
• Miller F. Nausea and vomiting in pregnancy: the problem of perception—is it really a disease? Am J Obstet Gynecol. 2002;186:S182–S183.
   PubMed Web of Science ®Google Scholar
• Mazzotta P, Stewart DE, Koren G, et al. Factors associated with elective termination of pregnancy among Canadian and American women with nausea and vomiting of pregnancy. J Psychosom Obstet Gynaecol. 2001;22:7–12.
   PubMed Web of Science ®Google Scholar
• Piwko C, Ungar WJ, Einarson TR, et al. The weekly cost of nausea and vomiting of pregnancy for women calling the toronto motherisk program. Curr Med Res Opin. 2007;23:833–840.
   PubMed Web of Science ®Google Scholar
• Piwko C, Koren G, Babashov V, et al. Economic burden of nausea and vomiting of pregnancy in the USA. J Popul Ther Clin Pharmacol. 2013;20:10.
   Google Scholar
• Einarson A, Maltepe C, Boskovic R, et al. Treatment of nausea and vomiting in pregnancy: an updated algorithm. Can Fam Physician. 2007;53:2109–2111.
   PubMed Web of Science ®Google Scholar
• Jewell D, Young G. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2003;4:CD000145.
   PubMedGoogle Scholar
• Scorza K, Williams A, Phillips JD, et al. Evaluation of nausea and vomiting. Am Fam Physician. 2007;76(1):76–84.
   PubMed Web of Science ®Google Scholar
• Gill SK, Einarson A. The safety of drugs for the treatment of nausea and vomiting of pregnancy. Expert Opin Drug Saf. 2007;6:685–694.
   PubMed Web of Science ®Google Scholar
• Brent RL. Bendectin: review of the medical literature of a comprehensively studied human nonteratogen and the most prevalent tortogen–litigen. Reprod Toxicol. 1995;9:337–349.
   PubMed Web of Science ®Google Scholar
• Einarson TR, Leeder JS, Koren G. A method for meta-analysis of epidemiological studies. Drug Intell Clin Pharm. 1988;22:813–824.
   PubMedGoogle Scholar
• McKeigue PM, Lamm SH, Linn S, et al. Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. Teratology. 1994;50:27–37.
   PubMedGoogle Scholar
• Magee LA, Mazzotta P, Koren G. Evidence-based view of safety and effectiveness of pharmacologic therapy for nausea and vomiting of pregnancy (NVP). Am J Obstet Gynecol. 2002;186(5Suppl Understanding):S256–61.
   PubMed Web of Science ®Google Scholar
• Koren G, Clark S, Hankins GD, et al. Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. Am J Obstet Gynecol. 2010;203:16–21.
   Web of Science ®Google Scholar
• Slaughter SR, Hearns-Stokes R, van der Vlugt T, et al. FDA approval of doxylamine-pyridoxine therapy for use in pregnancy. N Engl J Med. 2014;370(20):1081–1083.
   PubMed Web of Science ®Google Scholar
• Weigel RM, Weigel MM. Nausea and vomiting of early pregnancy and pregnancy outcome. A meta-analytical review. Br J Obstet Gynaecol. 1989;96:1312–1318.
   PubMedGoogle Scholar
• Nulman I, Rovet J, Barrera M, et al. Long-term neurodevelopment of children exposed to maternal nausea and vomiting of pregnancy and Diclectin. J Pediatr. 2009;155:45–50.
   PubMed Web of Science ®Google Scholar
• Veenendaal MV, Van Abeelen AF, Painter RC, et al. Consequences of hyperemesis gravidarum for offspring: a systematic review and meta-analysis. BJOG. 2011;118:1302–1313.
   PubMed Web of Science ®Google Scholar
• Van Oppenraaij RH, Jauniaux E, Christiansen OB, et al. Predicting adverse obstetric outcome after early pregnancy events and complications: a review. Hum Reprod Update. 2009;15:409–421.
   PubMed Web of Science ®Google Scholar
• Roseboom TJ, Ravelli AC, Van Der Post JA, et al. Maternal characteristics largely explain poor pregnancy outcome after hyperemesis gravidarum. Eur J Obstet Gynecol Reprod Biol. 2011;156:56–59.
   PubMed Web of Science ®Google Scholar
• Nulman I, Maltepe C, Farine D, et al. Neurodevelopment of children after maternal hospitalization for nausea and vomiting of pregnancy. Obstet Gynecol. 2015;125(Suppl 1):81S.
   Google Scholar
• Coetzee RL, Cormack B, Sadler L, et al. Pregnancy and neonatal outcomes following hyperemesis gravidarum. J Dev Orig Health Dis. 2011;2:8108.
   Web of Science ®Google Scholar
• Fejzo MS, Magtira A, Schoenberg FP, et al. Neurodevelopmental delay in children exposed in utero to hyperemesis gravidarum. Eur J Obstet Gynecol Reprod Biol. 2015;189:79–84.
   PubMed Web of Science ®Google Scholar
• Mullin PM, Bray A, Schoenberg F, et al. Prenatal exposure to hyperemesis gravidarum linked to increased risk of psychological and behavioral disorders in adulthood. J Dev Orig Health Dis. 2011 Aug;2(4):200–204.
   PubMed Web of Science ®Google Scholar
• Eventov-Friedman S, Klinger G, Shinwell ES. Third trimester fetal intracranial hemorrhage owing to vitamin K deficiency associated with hyperemesis gravidarum. J Pediatr Hematol Oncol. 2009;31:985–988.
   PubMed Web of Science ®Google Scholar
• Di Gangi S, Gizzo S, Patrelli TS, et al. Wernicke’s encephalopathy complicating hyperemesis gravidarum. J Maten Fetal Neonatal Med. 2012;25:499–504.
   Web of Science ®Google Scholar
• Vandrass KF, Grjibovski AM, Stoer NC, et al. Hyperemesis gravidarum and maternal cancer risk, a Scandinavian nested case control study. Int J Cancer. 2015;137:1209–1216.
   PubMed Web of Science ®Google Scholar
• Vandrass KF, Vikanes AV, Stoer NC, et al. Hyperemesis gravidarum and risk of cancer in offspring, a Scandinavian registry-based nested case- control study. BMC Cancer. 2015;15:398.
   PubMed Web of Science ®Google Scholar
• Ayyavoo A, Derraik JG, Hofman PL, et al. Severe hyperemesis gravidarum is associated with reduced insulin sensitivity in the offspring in childhood. J Clin Endocrinil Metab. 2013;98:3263–3268.
   PubMed Web of Science ®Google Scholar
• Fossum S, Vikanes AV, Naess O, et al. Hyperemesis gravidarum and long term mortality: a population based cohort study. BJOG. 2017;124:1080–1087.
   PubMed Web of Science ®Google Scholar
• Koot MH, Grooten IJ, Sebert S, et al. Hyperemesis gravidarum and cardiometabolic risk factors in adolescents; a follow up of Northern Finland Birth cohort 1986. BJOG. 2017;124:1107–1114.
   PubMed Web of Science ®Google Scholar
• Akdemir N, Bilir C. Thyroid dysfunction in hyperemesis gravidarum: a study in Turkish pregnant women. J Turk Ger Gynecol Assoc. 2011;12:140–143.
   PubMedGoogle Scholar
• Hizli D, Kamalak Z, Kosus, et al. Hyperemesis gravidarum and depression in pregnancy; is there an association? J Psychosom Obstet Gynaecol. 2012;33:171–175.
   PubMed Web of Science ®Google Scholar
• Tan PC, Zaidi SN, Azmi N, et al. Depression, anxiety, stress and hyperemesis gravidarum: temporal and case controlled correlates. PLoS One. 2014;17:9:e92036.
   Google Scholar
• Lawlor DA, Tilling K, Davey Smith G. Triangulation in aetiological epidemiology. Int J Epidemiol. 2016;45:1866–1886.
   PubMed Web of Science ®Google Scholar
• Neutel CI, Johansen HL. Measuring drug effectiveness by default: the case of Bendectin. Can J Public Health. 1995;86:66–70.
   PubMed Web of Science ®Google Scholar
• McKeigue PM, Lamm SH, Linn S, et al. Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. Teratology. 1994;50:27–37.
   PubMedGoogle Scholar
• Etwel F, Faught LH, Rieder MJ, et al. The risk of adverse pregnancy outcome after first trimester exposure to H1 Antihistamines: a systematic review and meta-analysis. Drug Saf. 2017;40:121–132.
   PubMed Web of Science ®Google Scholar
• Matok I, Gorodischer R, Koren G. The safety of metoclopramide use in the first trimester of pregnancy. N Engl J Med. 2009;360(11):2528–2535.
   PubMed Web of Science ®Google Scholar
• Pasternak B, Svanström H, Mølgaard-Nielsen D, et al. Metoclopramide in pregnancy and risk of major congenital malformations and fetal death. JAMA. 2013;310(16):1601–1611.
   PubMed Web of Science ®Google Scholar
• Taylor LG, Bird ST, Sahin L. Antiemetic use among pregnant women in the United States: the escalating use of ondansetron. Pharmacoepidemiol Drug Saf. 2017 Feb 21. DOI:10.1002/pds.4185
   Web of Science ®Google Scholar
• Pasternak B, Svanström H, Hviid A. Ondansetron in pregnancy and risk of adverse fetal outcomes. N Engl J Med. 2013;368:814–823.
   PubMed Web of Science ®Google Scholar
• Danielsson B, Wikner BN, Källén B. Use of ondansetron during pregnancy and congenital malformations in the infant. Reprod Toxicol. 2014;50:134–137.
   PubMed Web of Science ®Google Scholar
• Anderka M, Mitchell AA, Louik C, et al. National birth defects prevention study. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol. 2012;94:22–30.
   PubMed Web of Science ®Google Scholar
• Koren G, Madjunkova S, Maltepe C. The protective effects of nausea and vomiting of pregnancy against adverse fetal outcome–a systematic review. Reprod Toxicol. 2014;47:77–80.
   PubMed Web of Science ®Google Scholar
• Fejzo MS, MacGibbon KW, Mullin PM. Ondansetron in pregnancy and risk of adverse fetal outcomes in the United States. Reprod Toxicol. 2016;62:87–91.
   PubMed Web of Science ®Google Scholar
• Koren G, Bologa M, Long D, et al. Perception of teratogenic risk by pregnant women exposed to drugs and chemicals during the first trimester. Am J Obstet Gynecol. 1989;160:1190–1194.
   PubMed Web of Science ®Google Scholar
• Peterson I, McCrea RL, Lupatelli A, et al. Women’s perceptionof risks of adverse fetal pregnancy outcome: alarge scale multinational survey. BMJ Open. 2015Jun 1;5:e007390.
   Web of Science ®Google Scholar
• Mazzotta P, Magee LA, Maltepe C, et al. The perception of teratogenic risk by women with nausea and vomiting of pregnancy. Reprod Toxicol. 1999;13:313–319.
   PubMed Web of Science ®Google Scholar
• Soldin OP, Mattison DR. Sex differences in pharmacokinetics and pharmacodynamics. Clin Pharmacokinet. 2009;48:143–157.
   PubMed Web of Science ®Google Scholar
• Koren G, Clark S, Hankins GD, et al. Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial. BMC Pregnancy Childbirth. 2015;18;15:59.
   Web of Science ®Google Scholar
• Boelig RC, Barton SJ, Saccone, et al. Interventions for treating hyperemesis gravidarum: a Cochrane systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2017;11:1–14.
   Google Scholar
• McParlin C, O’Donnell A, Robson SC, et al. Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review. JAMA. 2016;316:1392–1401.
   PubMed Web of Science ®Google Scholar