References
  1. Fejzo MS, Trovik J, Grooten IJ et al. Nausea and vomiting of pregnancy and hyperemesis gravidarum. Nat Rev Dis Primers 2019; 5: 1– 17.
  2. Einarson TR, Piwko C, Koren G. Quantifying the global rates of nausea and vomiting of pregnancy: a meta analysis. J Popul Ther Clin Pharmacol. 2013;20:e171- e183.
  3. Fiaschi L, Nelson- Piercy C, Gibson J, Szatkowski L, Tata LJ. Adverse maternal and birthoutcomes in women admitted to hospital for hyperemesis gravidarum: a population- based cohort study. Paediatr Perinat Epidemiol. 2018;32:40- 51.
  4. Lowe SA, Armstrong G, Beech A et al. SOMANZ position paper on the management of nausea and vomiting in pregnancy and hyperemesis gravidarum. Aust N Z J Obstet Gynaecol 2020; 60: 34– 43.
  5. The Management of Nausea and Vomiting of Pregnancy and Hyperemesis Gravidarum (Green-top Guideline No. 69) [Internet]. Royal College of Obstetricians & Gynaecologists. [cited 2020 Feb 25]. Available from: https://www.rcog.org.uk/en/guide lines -research-services/guide lines/ gtg69/
  6. Fiaschi L, Nelson-Piercy C, Deb S, King R, Tata LJ. Clinical management of nausea and vomiting in pregnancy and hyperemesis gravidarum across primary and secondary care: a population-based study. BJOG Int J Obstet Gynaecol. 2019; 126:1201-1211.
  7. Taylor LG, Bird ST, Sahin L, et al. Antiemetic use among pregnant women in the United States: the escalating use of ondansetron. Pharmacoepidemiol Drug Saf. 2017;26:592-596.
  8. Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 189: Nausea And Vomiting Of Pregnancy. Obstet Gynecol. 2018;131:e15–30.
  9. Koren, G. (2014). Treating morning sickness in the United States—Changes in prescribing are needed. American Journal of Obstetrics and Gynecology, 2014,211(6), 602–606.https://doi.org/10.1016/j.ajog.2014.08.017
  10. Parker, S. E., Van Bennekom, C., Anderka, M.,Mitchell, A. A., & National Birth Defects Prevention Study.(2018). Ondansetron for treatment of nausea and vomiting of pregnancy and the risk of specific birth defects. Obstetrics and Gynecology, 2018,132(2), 385–394.https://doi.org/10.1097/AOG.0000000000002679
  11. Taylor, L. G., Bird, S. T., Sahin, L., Tassinari, M. S., Greene, P.,Reichman, M. E., … Toh, S. (2017). Antiemetic use among pregnant women in the United States: The escalating use of ondansetron. Pharmacoepidemiology and Drug Safety, 26(5),592–596.https://doi.org/10.1002/pds.4185
  12. Raymond, S. H. (2013). A survey of prescribing for the management of nausea and vomiting in pregnancy in Australasia. The Australian & New Zealand Journal of Obstetrics & Gynaecology,2013;53(4), 358–362.https://doi.org/10.1111/ajo.12045
  13. van Gelder MMHJ, Nordeng H. Antiemetic Prescription Fills in Pregnancy: A Drug Utilization Study Among 762,437 Pregnancies in Norway. Clin Epidemiol. 2021; 13:161-174. doi: 10.2147/CLEP.S287892. eCollection 2021.
  14. Hurault-Delarue C, Araujo M, Vabre C, Benevent J, Damase-Michel C, Lacroix I. What changes in prescription patterns of antiemetic medications in pregnant women in France? Fundam Clin Pharmacol. 2021. doi: 10.1111/fcp.12681. Online ahead of print.
  15. Ondansetron 4 mg film-coated tablets - Summary of Product Characteristics (SmPC) - (emc) [Internet]. [cited 2020 Feb 25]. Available from: https://www.medic ines.org.uk/emc/produ ct/5222/smpc#PREGN ANCY
  16. Damkier P, Kaplan YC, Shechtman S, Diav-Citrin O, Cassina M, Weber-Schoendorfer C. Ondansetron in pregnancy revisited: Assessment and pregnancy labelling by the European Medicines Agency (EMA) & Pharmacovigilance Risk Assessment Committee (PRAC).Basic Clin Pharmacol Toxicol. 2021;128(4):579-582. doi: 10.1111/bcpt.13541. Epub 2020 Dec 16.
  17. Melissa Lavecchia, Radha Chari, Sandra Campbell, Sue Ross. Ondansetron in Pregnancy and the Risk of Congenital Malformations: A Systematic Review. J Obstet Gynaecol Can. 2018 Jul;40(7):910-918. doi: 10.1016/j.jogc.2017.10.024.
  18. Yusuf Cem Kaplan, Jonathan Luke Richardson, Elif Keskin-Arslan, Hilal Erol-Coskun, Debra Kennedy. Use of ondansetron during pregnancy and the risk of major congenital malformations: A systematic review and meta-analysis. Reprod Toxicol. 2019; 86:1-13. doi: 10.1016/j.reprotox.2019.03.001.
  19. Shaun D Carstairs. Ondansetron Use in Pregnancy and Birth Defects: A Systematic Review. Obstet Gynecol. 2016;127(5):878-883. doi: 10.1097/AOG.0000000000001388.
  20. Cyndie Picot, Anick Berard, Guillaume Grenet, Emmanuelle Ripoche, Michel Cucherat, Judith Cottin. Risk of malformation after ondansetron in pregnancy: An updated systematic review and meta-analysis. Birth Defects Res. 2020;112(13):996-1013. doi: 10.1002/bdr2.1705.
  21. Razan Sakran, Svetlana Shechtman, Judy Arnon, Orna Diav-Citrin. Pregnancy outcome following in-utero exposure to ondansetron: A prospective comparative observational study. Reprod Toxicol. 2021; 99:9-14. doi: 10.1016/j.reprotox.2020.11.005.
  22. Colin R Dormuth, Brandace Winquist, Anat Fisher, Fangyun Wu, Pauline Reynier, Samy Suissa, Matthew Dahl, Zhihai Ma, Xinya Lu, Jianguo Zhang, Colette B Raymond, Kristian B Filion, Robert W Platt, Carolina Moriello, J Michael Paterson, Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Comparison of Pregnancy Outcomes of Patients Treated With Ondansetron vs Alternative Antiemetic Medications in a Multinational, Population-Based Cohort. JAMA Netw Open. 2021;4(4):e215329. doi: 10.1001/jamanetworkopen.2021.5329.
  23. Lara S Lemon, Lisa M Bodnar, William Garrard, Raman Venkataramanan, Robert W Platt, Oscar C Marroquin, Steve N Caritis. Ondansetron use in the first trimester of pregnancy and the risk of neonatal ventricular septal defect. Int J Epidemiol. 2020;49(2):648-656. doi: 10.1093/ije/dyz255.
  24. Krista F Huybrechts, Sonia Hernandez-Diaz, Loreen Straub, Kathryn J Gray, Yanmin Zhu, Helen Mogun 1, Brian T Bateman. Intravenous Ondansetron in Pregnancy and Risk of Congenital Malformations. JAMA. 2020;323(4):372-374. doi: 10.1001/jama.2019.18587.
  25. Elizabeth A Suarez, Kim Boggess, Stephanie M Engel, Til Stürmer, Jennifer L Lund, Michele Jonsson Funk. Ondansetron use in early pregnancy and the risk of late pregnancy outcomes. Pharmacoepidemiol Drug Saf. 2021;30(2):114-125. doi: 10.1002/pds.5151.
  26. The Ottawa Hospital, Wells GA, Shea B, O’Connell D, et al. The Newcastle-Ottawa Scale (NOS) for Assessing the Quality of Non randomised Studies in Meta-Analyses. 2001. http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp. [Accessed 20 January 2018].
  27. Evidence Partners. Methodological resources. https://www.evidencepartners.com/resources/methodological-resources/. [Accessed 10 September 2019].
  28. Long Ge, Gordon Guyatt, Jinhui Tian, Bei Pan, Yaping Chang, Yajing Chen, et al. Insomnia and risk of mortality from all-cause, cardiovascular disease, and cancer: Systematic review and meta-analysis of prospective cohort studies. Sleep Med Rev. 2019; 48:101215. doi: 10.1016/j.smrv.2019.101215.
  29. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ.2003;327:557e60.
  30. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics.1994;50:1088e101.
  31. Iorio A, Spencer FA, Falavigna M, Alba C, Lang E, Burnand B, et al. Use of GRADE for assessment of evidence about prognosis: rating confidence in estimates of event rates in broad categories of patients. BMJ.2015;350:h870.
  32. D. Moher, A. Liberati, J. Tetzlaff, Altman DG for the PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 339 (2009) b2535.
  33. Marlena S Fejzo, Kimber W MacGibbon, Patrick M Mullin. Ondansetron in pregnancy and risk of adverse fetal outcomes in the United States. Reprod Toxicol. 2016; 62:87-91. doi: 10.1016/j.reprotox.2016.04.027.
  34. Şafak Özdemirci, F Akpınar, Bilge M, F Özdemirci,S Yılmaz,D Esinler,İnci Kahyaoğlu. The Safety of Ondansetron and Chlorpromazine for Hyperemesis Gravidarum in First Trimester Pregnancy. Gynecol Obstet Reprod Med. 2014;20:81-84.
  35. Lyn Colvin, Andrew W Gill, Linda Slack-Smith, Fiona J Stanley, Carol Bower. Off-label use of ondansetron in pregnancy in Western Australia. Biomed Res Int. 2013:909860. doi: 10.1155/2013/909860.
  36. Anick Bérard, Odile Sheehy, Jessica Gorgui, Jin-Ping Zhao, Cristiano Soares de Moura, Sasha Bernatsky. New evidence for concern over the risk of birth defects from medications for nausea and vomitting of pregnancy. J Clin Epidemiol. 2019; 116:39-48. doi: 10.1016/j.jclinepi.2019.07.014.
  37. Charlotte Asker, B Norstedt Wikner, Bengt Källén. Use of antiemetic drugs during pregnancy in Sweden. Eur J Clin Pharmacol. 2005;61(12):899-906. doi: 10.1007/s00228-005-0055-1.
  38. Colin R Dormuth, Brandace Winquist, Anat Fisher, Fangyun Wu, Pauline Reynier, Samy Suissa, et al. Comparison of Pregnancy Outcomes of Patients Treated With Ondansetron vs Alternative Antiemetic Medications in a Multinational, Population-Based Cohort. JAMA Netw Open. 2021 Apr 1;4(4):e215329. doi: 10.1001/jamanetworkopen.2021.5329.
  39. Lara S Lemon, Lisa M Bodnar, William Garrard, Raman Venkataramanan, Robert W Platt, Oscar C Marroquin, et al. Ondansetron use in the first trimester of pregnancy and the risk of neonatal ventricular septal defect. Int J Epidemiol. 2020;49(2):648-656. doi: 10.1093/ije/dyz255.
  40. Adrienne Einarson, Caroline Maltepe, Yvette Navioz, Deborah Kennedy, Michael Paul Tan, Gideon Koren. The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study. BJOG. 2004;111(9):940-3. doi: 10.1111/j.1471-0528.2004.00236.x.
  41. Krista F Huybrechts, Sonia Hernandez-Diaz, Loreen Straub, Kathryn J Gray, Yanmin Zhu, Helen Mogun, et al. Intravenous Ondansetron in Pregnancy and Risk of Congenital Malformations. JAMA. 2020;323(4):372-374. doi: 10.1001/jama.2019.18587.
  42. Elizabeth A Suarez, Kim Boggess, Stephanie M Engel, Til Stürmer, Jennifer L Lund, Michele Jonsson Funk. Ondansetron use in early pregnancy and the risk of late pregnancy outcomes. Pharmacoepidemiol Drug Saf. 2021;30(2):114-125. doi: 10.1002/pds.5151.
  43. Björn Pasternak, Henrik Svanström, Anders Hviid. Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes. N Engl J Med. 2013;368(9):814-23. doi: 10.1056/NEJMoa1211035.
  44. Martha M Werler, Mahsa M Yazdy, James R Kasser, Susan T Mahan, Robert E Meyer, Marlene Anderka, et al. Medication use in pregnancy in relation to the risk of isolated clubfoot in offspring. Am J Epidemiol. 2014;180(1):86-93. doi: 10.1093/aje/kwu096.
  45. April Zambelli-Weiner, Christina Via, Matt Yuen, Daniel J Weiner, Russell S Kirby. First trimester ondansetron exposure and risk of structural birth defects. Reprod Toxicol. 2019; 83:14-20. doi: 10.1016/j.reprotox.2018.10.010.
  46. Razan Sakran, Svetlana Shechtman, Judy Arnon, Orna Diav-Citrin. Pregnancy outcome following in-utero exposure to ondansetron: A prospective comparative observational study. Reprod Toxicol. 2021 Jan;99:9-14. doi: 10.1016/j.reprotox.2020.11.005.
  47. Bengt Danielsson, Birgitta Norstedt Wikner, Bengt Källén. Use of ondansetron during pregnancy and congenital malformations in the infant. Reprod Toxicol. 2014; 50:134-7. doi: 10.1016/j.reprotox.2014.10.017.
  48. Samantha E Parker, Carla Van Bennekom, Marlene Anderka, Allen A Mitchell. Ondansetron for Treatment of Nausea and Vomiting of Pregnancy and the Risk of Specific Birth Defects. Obstet Gynecol. 2018 Aug;132(2):385-394. doi: 10.1097/AOG.0000000000002679.
  49. Michael Couse, Saba Syed. A Rise in Aspartate Transaminase and Alanine Transaminase Associated With Ondansetron Administration in a Pregnant Female. Cureus. 2020 Nov 18;12(11):e11540. doi: 10.7759/cureus.11540.
  50. Lara S Lemon, Hongfei Zhang, Mary F Hebert, Gary D Hankins, David M Haas, Steve N Caritis. Ondansetron Exposure Changes in a Pregnant Woman. Pharmacotherapy. 2016 Sep;36(9):e139-41. doi: 10.1002/phar.1796.
  51. E Ferreira, M Gillet, J Lelièvre, J-F Bussières. Ondansetron use during pregnancy: a case series. J Popul. Ther Clin Pharmacol. 2012;19(1):e1-e10.
  52. Yusuf Cem Kaplan, Jonathan Luke Richardson, Elif Keskin-Arslan, Hilal Erol-Coskun, Debra Kennedy. Use of ondansetron during pregnancy and the risk of major congenital malformations: A systematic review and meta-analysis. Reprod Toxicol. 2019;86:1-13. doi: 10.1016/j.reprotox.2019.03.001.
  53. Cyndie Picot, Anick Berard, Guillaume Grenet, Emmanuelle Ripoche, Michel Cucherat, Judith Cottin. Risk of malformation after ondansetron in pregnancy: An updated systematic review and meta-analysis. Birth Defects Res. 2020;112(13):996-1013. doi: 10.1002/bdr2.1705.
  54. Melissa Lavecchia, Radha Chari, Sandra Campbell, Sue Ross. Ondansetron in Pregnancy and the Risk of Congenital Malformations: A Systematic Review. J Obstet Gynaecol Can. 2018;40(7):910-918. doi: 10.1016/j.jogc.2017.10.024.
  55. Shaun D Carstairs. Ondansetron Use in Pregnancy and Birth Defects: A Systematic Review. Obstet Gynecol. 2016 May;127(5):878-883. doi: 10.1097/AOG.0000000000001388.
  56. Lyn Colvin, Andrew W Gill, Linda Slack-Smith, Fiona J Stanley, Carol Bower. Off-label use of ondansetron in pregnancy in Western Australia. Biomed Res Int. 2013;2013:909860. doi: 10.1155/2013/909860.
  57. L.G. Taylor, S.T. Bird, L. Sahin, M.S. Tassinari, P. Greene, M.E. Reichman,S.E. Andrade, K. Haffenreffer, S. Toh, Antiemetic use among pregnant women in the United States: the escalating use of ondansetron, Pharmacoepidemiol. Drug Saf. 26(5) (2017) 592–596.
Table 1 Study characteristics