Selected References:

• Ali, R, et al. 2022. Review of recent evidence on the management of heartburn in pregnant and breastfeeding women. BMC gastroenterology; 22.1: 1-10.
• Anderka M, et al. 2012. 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; 94:22-30.
• Andersen ABT, et al. 2012. Prenatal exposure to acid-suppressive drugs and the risk of toddler asthma: a population-based Danish cohort study. Alim Pharmacol Ther; 35:1190-1198.
• Anderson P. 2018. Treating gastroesophageal reflux and heartburn while breastfeeding. Breastfeed Med;13(7):463–4.
• Bank, T, et al. 2024. Challenges in Conducting Clinical Trials for Preeclampsia. Curr Hypertens Rep 26, 59–68.
• Bor S, et al. 2017. The levels of pantoprazole in human breast milk and plasma: two compartment model. Neurogastroenterol Motil; 29:79–80.
• Dehlink E, et al. 2009. First evidence of a possible association between gastric acid suppression during pregnancy and childhood asthma: a population-based register study. Clin Exp Allergy 39:246-53.
• Diav-Citrin O, et al. 2005. The safety of proton pump inhibitors in pregnancy: a multicentre prospective controlled study. Aliment Pharmacol Ther; 21:269-75.
• Erichsen R, et al. 2014. Maternal use of proton pump inhibitors during early pregnancy and the prevalence of hypospadias in male offspring. Am J Ther; 21: 254-259.
• Gill SK et al. 2009. The safety of proton pump inhibitors (PPIs) in pregnancy: a meta-analysis. Am J Gastroenterol; 104(6): 1541-1545.
• Hastie R, et al. 2019. Proton pump inhibitors and preeclampsia risk among 157 720 women: a Swedish population register–based cohort study. Hypertension; 73(5):1097–103.
• Huijgen NA. 2016. Are proton-pump inhibitors harmful for the semen quality of men in couples who are planning pregnancy? Fertility and Sterility, 106(7), 1666-1672.
• Kallen B. 1998. Delivery outcome after the use of acid-suppressing drugs in early pregnancy with special reference to omeprazole. Br J Obstet Gynaecol; 105:877-881.
• Kallen B. 2001. Use of omeprazole during pregnancy—no hazard demonstrated in 955 infants exposed during pregnancy. Eur J Obstet Gynecol Reprod Biol; 96:63-68.
• Keihani, S. et al. 2018. Proton-pump inhibitor use does not affect semen quality in subfertile men. Asian journal of andrology, 20(3), 290.
• Lalkin A, et al. 1998. The safety of omeprazole during pregnancy: a multicenter prospective controlled study. Am J Obstet Gynecol; 179(3 Pt 1): 727-730.
• Li, C, et al. 2020. Systematic review with meta‐analysis: the risks of proton pump inhibitors during pregnancy. Alimentary pharmacology & therapeutics; 51.4: 410-420.
• Mahadevan, Uma. 2007. “Gastrointestinal Medications in Pregnancy.” Best Practice & Research Clinical Gastroenterology 21(5): 849–77.
• Majithia, R., & Johnson, D. A. (2012). Are Proton Pump Inhibitors Safe during Pregnancy and Lactation? 10.
• Marshall JK, et al. 1998. Omeprazole for refractory gastroesophageal reflux disease during pregnancy and lactation. Can J Gastroenterol; 12: 225-227.
• Matok I, et al. 2012. The safety of fetal exposure to proton-pump inhibitors during pregnancy. Dig Dis Sci; 57:699-705.
• Mumtaz, N, et al. Harmful Consequences of Proton Pump Inhibitors on Male Fertility: An Evidence from Subchronic Toxicity Study of Esomeprazole and Lansoprazole in Wistar Rats. International Journal of Endocrinology.
• Nikfar S, et al. 2002. Use of proton pump inhibitors during pregnancy and rates of major malformations: a meta-analysis. Dig Dis Sci; 47:1526-9.
• Neuman R, et al. 2022. Omeprazole Administration in Preterm Preeclampsia: a Randomized Controlled Trial to Study Its Effect on sFlt-1 (Soluble Fms-Like Tyrosine Kinase-1), PlGF (Placental Growth Factor), and ET-1 (Endothelin-1). Hypertension, vol. 79,6: 1297-1307.
• Pasternak B, Hviid A. 2010. Use of proton-pump inhibitors in early pregnancy and the risk of birth defects. N Engl J Med; 363:2114-2123.
• Saito J, et al. 2020. Esomeprazole During Pregnancy and Lactation: Esomeprazole Levels in Maternal Serum, Cord Blood, Breast Milk, and the Infant’s Serum. Breastfeeding Medicine, bfm.2020.0175.
• Thélin CS, & Richter JE. 2020. Review article: the management of heartburn during pregnancy and lactation. Alimentary Pharmacology & Therapeutics, 51(4), 421–434.
• Yitshak-Sade M, et al. 2016. Prenatal exposure to H2 blockers and to proton pump inhibitors and asthma development in offspring. J Clinic Pharmacol; 56: 116-123

Selected References:

• Affendi Raja RA, et al. 2022. Review of recent evidence on the management of heartburn in pregnant and breastfeeding women. BMC Gastroenterology, 22:219-229.
• Courtney TP, et al. 1988. Excretion of famotidine in breast milk. Br J Clin Pharmacol, 626:639P.
• Garbis H, et al. 2005. Pregnancy outcome after exposure to ranitidine and other H2-blockers. A collaborative study of the European Network of Teratology Information Services. Reprod Toxicol, 19:453-458.
• Hagemann, TM, 1998. Gastrointestinal medications and breastfeeding. Journal of Human Lactation, 14(3):259–262.
• Kallen B, 1998. Delivery outcome after the use of acid-suppressing drugs in early pregnancy with special reference to omeprazole. Journal of Obstetrics and Gynecology, 105:877-881.
• Magee LA, et al.1996. Safety of first trimester exposure to histamine H2 blockers. A prospective cohort study. Dig Dis Sci, 41(6):1145-1149.
• Matok I, et al. 2010. The safety of H (2)-blockers use during pregnancy. J Clin Pharmacol, 50(1):81-87.
• Orenstein SR, Shalaby TM, Devandry SN, et al. 2003. Famotidine for infant gastro-oesophageal reflux: A multi-centre, randomized, placebo-controlled, withdrawal trial. Aliment Pharmacol Ther, 7(9):1097-107.
• Savarino V, et al. 1988. Famotidine has no significant effect on gonadal function in man. Gastroenterol Clin Biol, 12:19-22.
• Wang X, et al. 2011. Pharmacokinetics of famotidine in pregnant women. Am J Obstet Gynecol., 204: 72-73.
• Yitshak-Sade M, et al. 2016. Prenatal exposure to H2 blockers and to proton pump inhibitors and asthma development in offspring. J Clin Pharmacol, 56(1):116-123.

Selected References:

• Barrau M, et al. 2023. What Should We Know about Drug Levels and Therapeutic Drug Monitoring during Pregnancy and Breastfeeding in Inflammatory Bowel Disease under Biologic Therapy?. J Clin Med. 12(23):7495.
• Bell C, et al. 2021. Systematic review and meta-analysis: Safety of vedolizumab during pregnancy in patients with inflammatory bowel disease. J Gastroenterol Hepatol;36(10):2640-2648. PMID: 34110640 DOI: 10.1111/jgh.15574
• Caballero-Mateos AM, et al. 2023. IBD and Motherhood: A Journey through Conception, Pregnancy and Beyond. J Clin Med. 12(19):6192.
• Chugh R. 2023. Maternal and Neonatal Outcomes in Vedolizumab and Ustekinumab Exposed Pregnancies: Results from the PIANO registry. Am J Gastroenterol. DOI: 10.14309/ajg.0000000000002553.
• Ding N, et al. 2022. Management of biologics in pregnant, lactating patients with inflammatory bowel disease and the impact on neonatal vaccination: A systematic review of clinical practice guidelines and consensus statements. J Clin Pharm Ther. 47(12):1952-1965.
• Gisbert JP, et al. 2023. Vaccines in Children Exposed to Biological Agents In Utero and/or During Breastfeeding: Are They Effective and Safe?. J Crohns Colitis. 17 (6):995-1009.
• Gisbert JP, et al. 2020. Safety of New Biologics (Vedolizumab and Ustekinumab) and Small Molecules (Tofacitinib) During Pregnancy: A Review. Drugs;80(11):1085-1100. PMID: 32562207 DOI: 10.1007/s40265-020-01346-4
• Honap S, et al. 2023. An update on the safety of long-term vedolizumab use in inflammatory bowel disease. Expert Opin Drug Saf. 22 (9):767-776.
• Julsgaard M, et al. 2017. Vedolizumab safety in pregnancy and newborn outcomes. Gut; 66(10):1866-1867.
• Julsgaard M, et al. 2018. Vedolizumab concentrations in the breast milk of nursing mothers with inflammatory bowel disease. Gastroenterology 154: 752-765.
• Lahat A, et al. 2018. Vedolizumab levels in breast milk of nursing mothers with inflammatory bowel disease. J Crohns Colitis; 12:120-3.
• Lamb CA, et al. 2019. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut ;68(Suppl 3):s1-s106. PMID: 31562236 PMCID: PMC6872448 DOI: 10.1136/gutjnl-2019-318484
• Laube R, et al. 2021. Use of medications during pregnancy and breastfeeding for Crohn’s disease and ulcerative colitis. Expert Opin Drug Saf ;20(3):275-292. PMID: 33412078 DOI: 10.1080/14740338.2021.1873948
• Mahadevan U, et al. 2017. Vedolizumab exposure in pregnancy: Outcomes from clinical studies in inflammatory bowel disease. Aliment Pharmacol Ther; 45:941-950.
• Mahadevan U, et al. 2017. Editorial: vedolizumab in pregnancy – is gut selectivity as good for baby as it is for mum? Authors’ reply. Aliment Pharmacol Ther. 45(9):1284.
• Meyer A, et al. 2024. Safety of Vedolizumab and Ustekinumab Compared With Anti-TNF in Pregnant Women With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. DOI: 10.1016/j.cgh.2023.12.029.
• Mitrova K, et al. 2022. Safety of Ustekinumab and Vedolizumab During Pregnancy-Pregnancy, Neonatal, and Infant Outcome: A Prospective Multicentre Study. Journal of Crohn’s & colitis. Vol 16, 12: 1808-1815.
• Moens A, et al. 2019. Outcome of pregnancies in female patients with inflammatory bowel diseases treated with vedolizumab. J Crohns Colitis 13(1): 12-13.
• Moens A, et al. 2020. Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study. Aliment Pharmacol Ther 51(1): 129-138.
• Nielsen OH. 2022. Biologics for Inflammatory Bowel Disease and Their Safety in Pregnancy: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 20(1):74-87.
• Pugliese D, et al. 2024. New drugs for the treatment of IBD during conception, pregnancy, and lactation. Dig Liver Dis. 56 (2): 235-241.
• Rosario M, et al. 2017. A Review of the Clinical Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Vedolizumab. Clin Pharmacokinet. 2017; 56(11): 1287–1301. PMCID: PMC5648740 PMID: 28523450
• Sheridan J, et al. 2017. Letter: Vedolizumab in Pregnancy. J Crohns Colitis; 11(8):1025-1026.
• Shitrit AB-G A, et al. 2019. Exposure to vedolizumab in IBD pregnant women appears of low risk for mother and neonate: A first perspective comparison study. Am J Gastroenterol 114(7): 1172-1175.
• Sun W, et al. 2021. Vedolizumab concentrations in breast milk: Results from a prospective, postmarketing, milk-only lactation study in nursing mothers with inflammatory bowel disease. Clin Pharmacokinet. 60:811-8.
• Takeda Pharmaceuticals America, Inc. 2018. Entyvio product label. Available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e94621c-1a95-4af9-98d1-52b9e6f1949c

Selected References:

• Andrade C. 2020. Major Congenital Malformation Risk After First Trimester Gestational Exposure to Oral or Intravenous Ondansetron. J Clin Psychiatry;81(3):20f13472
• Anderka M, et al. 2012. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol; 94(1):22–30.
• Briggs GG, Freeman RK. 2014. Drugs in Pregnancy and Lactation. 10^th edition. Philadelphia, PA: Wolters Kluwer (online version).
• Kaplan YC, et al. 2019. Use of ondansetron during pregnancy and the risk of major congenital malformations: A systemic review and meta-analysis. Reprod Toxicol; 86 Jun:1-13.
• Cao X, et al. 2022. Risk of abnormal pregnancy outcomes after using ondansetron during pregnancy: A systematic review and meta-analysis. Front Pharmacol, 13(951072).
• Cohen R, et al. 2014. Intestinal obstruction in pregnancy by ondansetron. Reprod Toxicol. 2014 Oct 24;50C:152-153.
• Colvin L, et al. 2013. Off-label use of ondansetron in pregnancy in Western Australia. Biomed Res Int. 2013:909860.
• Danielsson B, Wikner BN, Kallen B. 2014. Use of ondansetron during pregnancy and congenital malformations in the infant. Reprod Toxicol 50:134-7.
• Diav-Citrin O, et al. 2017. Pregnancy outcome following in utero exposure to ondansetron: A prospective comparative, observational cohort study. Reprod Toxicol; 72:203.
• Dormuth CR, et al; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. 2021. Comparison of Pregnancy Outcomes of Patients Treated with Ondansetron vs Alternative Antiemetic Medications in a Multinational, Population-Based Cohort. JAMA Netw Open; 4(4):e215329.
• Einarson AK, et al. 2004. The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study. BJOG;111:940-3.
• Elkomy MH, et al. 2015. Ondansetron pharmacokinetics in pregnant women and neonates: towards a new treatment for neonatal abstinence syndrome. Clin Pharmacol Ther. 97:167-76.
• Fejzo MS, et al. 2016. Ondansetron in pregnancy and risk of adverse fetal outcomes in the United States. Reprod Toxicol 62: 87-91.
• Food and Drug Administration. 2012. FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran). https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-new-information-regarding-qt-prolongation-ondansetron-zofran. Accessed 2018 & 2022.
• Jelting Y, et al. 2017. Preventing nausea and vomiting in women undergoing regional anesthesia for cesarean section: Challenges and solutions. Local Reg Anesth, 10:83–90.
• Larrimer MB, et al. 2014. Antiemetic medications in pregnancy: a prospective investigation of obstetric and neurobehavioral outcomes. Am J Obstet Gynecol 210 (3): 270. e1-7
• Lavecchia M, et al. 2018. Ondansetron in Pregnancy and the Risk of Congenital Malformations: A Systematic Review. J Obstet Gynaecol Can. 40(7):910-918.
• Lemon LS, et al. 2020. Ondansetron use in the first trimester of pregnancy and the risk of neonatal ventricular septal defect. Int J Epidemiol;49(2):648-656.
• Masarwe S, et al. 2023. Ondansetron use during pregnancy: Birth defects and obstetric outcomes. Clin Nurs Res, 32(4):705-711.
• Pasternak B. 2013. Ondansetron in pregnancy and risk of adverse fetal outcomes. N Engl J Med 368:814-823.
• Picot C, et al. 2020. Risk of malformation after ondansetron in pregnancy: An updated systemic review and meta-analysis. Birth Defects Res;112(13):996-1013.
• Reis ACC, et al. 2023. Safety evaluation of ondanstron after gestational exposure on male reproductive parameters in rats. Regul Toxicol Pharmacol, 137:105302.
• Sakran R, et al. 2021. Pregnancy outcome following in-utero exposure to ondansetron: A prospective comparative observational study. Reprod Toxicol; 99:9-14.
• Schrager NL, et al. 2023. The association of nausea and vomiting of pregnancy, its treatments, and select birth defects: Findings from the National Birth Defect Prevention Study. Birth Defects Res, 115(3):275-289.
• Suarez EA, et al. 2021. Ondansetron use in early pregnancy and the risk of late pregnancy outcomes. Pharmacoepidemiol Drug Saf; 30(2):114-125.
• Suarez EA, et al. 2021. Ondansetron use in early pregnancy and the risk of miscarriage. Pharmacoepidemiol Drug Saf; 30(2):103-113.
• Zhao W, et al. 2020. Retrospective comparison of the safety and effectiveness of dexmedetomidine versus standard of care before and during cesarean delivery in a maternity unit in Zhengzhou, China. Med Sci Monit, 26:e925709.

Selected References:

• Andersen, J. B, et al. 2023. Pregnancy outcomes after early fetal exposure to injectable first-line treatments, dimethyl fumarate, or natalizumab in Danish women with multiple sclerosis. European journal of neurology, 30(1), 162–171.
• Ciplea, A. I, et al. 2020. Exposure to natalizumab during pregnancy and lactation is safe – Commentary. Multiple sclerosis (Houndmills, Basingstoke, England), 26(8), 892–893.
• D’Amico, E, et al. 2021. Male fertility in relapsing-remitting multiple sclerosis patients treated with natalizumab and ocrelizumab: A prospective case-control study. Multiple sclerosis (Houndmills, Basingstoke, England), 27(14), 2284–2287.
• Ebrahimi N, et al. 2014. Pregnancy and fetal outcomes following natalizumab exposure in pregnancy. A prospective, controlled observational study. Mult Scler. 2015 Feb;21(2):198-205.
• Friend S, et al. 2016. Evaluation of pregnancy outcomes from the Tysabri (natalizumab) pregnancy exposure registry: a global, observational, follow-up study. BMC Neurol. Aug 24;16(1):150
• Gklinos, P, et al. 2023. Monoclonal Antibodies in Pregnancy and Breastfeeding in Patients with Multiple Sclerosis: A Review and an Updated Clinical Guide.Pharmaceuticals (Basel, Switzerland),16(5), 770.
• Haghikia A, , et al. 2014. Natalizumab use during the third trimester of pregnancy. JAMA Neurol 71(7): 891-895.
• Mahadevan U, , et al. 2019. Inflammatory bowel disease in pregnancy clinical care pathway: a report from the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. Apr;156(5):1508-1524.
• Massarotti, C., et al. 2021. Effect of Multiple Sclerosis and Its Treatments on Male Fertility: Cues for Future Research. Journal of clinical medicine, 10(22), 5401
• O’Leary, S, et al. 2023. Practical Clinical Guidelines for Natalizumab Treatment in Patients With Relapsing Multiple Sclerosis. Journal of infusion nursing : the official publication of the Infusion Nurses Society, 46(6), 347–359.
• Oreja-Guevara, C, et al. 2023. Family Planning in Fertile-Age Patients With Multiple Sclerosis (MS) (ConPlanEM Study): Delphi Consensus Statements. Cureus, 15(8), e44056
• Peng A, et al. 2018. Natalizumab exposure during pregnancy in multiple sclerosis: a systematic review. J Neurol Sci. 2019 Jan 15;396:202-205.
• Portaccio E, et al. 2018. Pregnancy decision-making in women with multiple sclerosis treated with natalizumab. I: Fetal risks. Neurology. Page #s or journal volume?
• Simone, I. L, et al. 2021. Influence of Pregnancy in Multiple Sclerosis and Impact of Disease-Modifying Therapies.Frontiers in neurology,12, 697974.
• Tysabri. Drug Approval Package. Pharmacology reviews. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125104s000_natalizumab.cfm
• Ramesh, V, et al. 2022. Adverse Obstetric Outcomes in Pregnant Women Using Natalizumab for the Treatment of Multiple Sclerosis: A Systematic Review. Cureus,14(10), e29952