Proton Pump Inhibitors

Selected References:

  • Banihani SA, Khasawneh FH. 2018. Effect of lansoprazole on human sperm motility, sperm viability, seminal nitric oxide production, and seminal calcium chelation. Res Pharm Sci.13:460‐468.
  • Dağlı U, Kalkan IH. 2017. Treatment of reflux disease during pregnancy and lactation. Turk J Gastroenterol. 2017 Dec;28(Suppl 1):S53-S56.
  • Diav-Citrin O, et al. 2005. The safety of proton pump inhibitors in pregnancy: A multicenter prospective controlled trial. Aliment Pharmacol Ther; 21:269-75.
  • Escoffier, J, Arnaud, B, Kaba, M, et al. 2020. Pantoprazole, a proton‐pump inhibitor, impairs human sperm motility and capacitation in vitro. Andrology. 8: 1795– 1804.
  • Hastie R et al. 2019. Proton Pump Inhibitors and Preeclampsia Risk Among 157 720 Women. Hypertension. 73(5):1097-1103. doi: 10.1161/HYPERTENSIONAHA.118.12547.
  • Kallen BA. 2001. Use of omeprazole during pregnancy–no hazard demonstrated in 955 infants exposed during pregnancy. Eur J Obstet Gynecol Reprod Biol. 96(1):63-68.
  • Mahadevan U, Kane S. 2006. American Gastroenterological Association Institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology.131(1):283-331
  • Majithia R, Johnson DA. 2012. Are proton pump inhibitors safe during pregnancy and lactation? Evidence to date. Drugs. 72(2):171-179.
  • Marshall JK, et al. 1998. Omeprazole for refractory gastroesophageal reflux disease during pregnancy and lactation. Can J Gastroenterol. 12(3):225-7.
  • Matok I, et al. 2012. The safety of fetal exposure to proton-pump inhibitors during pregnancy. Dig Dis Sci.. 57(3):699-705.
  • Pasternak B, Hviid A. 2010. Use of proton pump inhibitors in early pregnancy and the risk of birth defects. N Egl J Med. 363(22): 2114-2123.
  • Plante L, et al. 2004. Excretion of pantoprazole in human breast. J Reprod Med. 2004;49:825-7.
  • Saito J, et al. 2020. Esomeprazole During Pregnancy and Lactation: Esomeprazole Levels in Maternal Serum, Cord Blood, Breast Milk, and the Infant’s Serum. Breastfeed Med. 15(9):598-601. doi: 10.1089/bfm.2020.0175. Epub 2020 Jul 7.
  • Ruigomez A, et al. 1999. Use of cimetidine, omeprazole, and ranitidine in pregnant women and pregnancy outcomes. Am J Epidemiol. 150(5):476-481.
  • Thélin CS, Richter JE. 2020. Review article: the management of heartburn during pregnancy and lactation. Aliment Pharmacol Ther. 51(4):421-434. doi: 10.1111/apt.15611. Epub 2020 Jan 17. PMID: 31950535 Review.


Proton Pump Inhibitors

Selected References: 

  • Bloor M, et al. 2012. Tramadol in pregnancy and lactation. Int J Obstet Anesth 21:163-7. 
  • Bowie AC, et al. 2022. Prescribed opioid analgesics in early pregnancy and the risk of congenital anomalies: a population-based cohort study. CMAJ. 194(5):E152-E162. 
  • Ferrer E, et al. 2025. Tramadol during pregnancy: risk of adverse pregnancy outcome and major congenital anomalies. A comparative study in the EFEMERIS database. Pharmacoepidemiol Drug Saf. 34(4):e70143. 
  • Hartenstein S, et al. 2010. Neonatal abstinence syndrome (NAS) after intrauterine exposure to tramadol. J Perinat Med 38: 695–6. 
  • Ilett KF, et al. 2008. Use of a sparse sampling study design to assess transfer of tramadol and its o-desmethyl metabolite into transitional breast milk. Br J Clin Pharmacol. 65:661-6. 
  • Kallen B & Reis M. 2015. Use of tramadol in early pregnancy and congenital malformation risk. Reprod Toxicol. 23;58:246-251.  
  • Kaur Makkar J, et al. 2015. Comparison of analgesic efficacy of paracetamol and tramadol for pain relief in active labor. Clin Anesth. 27(2):159-63.  
  • Meyer FP, et al. 1997. Tramadol withdrawal in a neonate. Eur J Clin Pharmacol 53: 159–60. 
  • O’Mara K, et al. 2010. Treatment of neonatal withdrawal with clonidine after long-term, high-dose maternal use of tramadol. Ann Pharmacother 44: 1342–4. 
  • Sawaddiruk P. 2011. Tramadol hydrochloride/acetaminophen combination for the relief of acute pain. Drugs Today (Barc). 47(10):763-772.  
  • Schuckit MA. 2016. Treatment of opioid-use disorders.  N Engl J.Med. 375:357–68 
  • Sørensen AMS, et al. 2022. Exposure to tramadol during early pregnancy and risk of spontaneous abortion or major congenital malformations. Obstet Gynecol.139(4):545-553.  
  • Subedi A. et al. 2013. Analgesic effects of intrathecal tramadol in patients undergoing caesarean section: a randomised, double-blind study. Int J Obstet Anesth. 22(4):316-21.  
  • U.S. Food & Drug Administration. Updated 10/2023. FDA drug safety communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against the use in breastfeeding women. Available from URL: https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm  
  • Willaschek C, et al. 2009. Tramadol withdrawal in a neonate after long-term analgesic treatment of the mother. Eur J Clin Pharmacol 65: 429–30. 


Proton Pump Inhibitors

Selected References:

  • Abdellatif M, et al. 2019. Association between exposure to macrolides and the development of infantile hypertrophic pyloric stenosis: a systematic review and meta-analysis. Eur J Pediatr 178(3):301-314.
  • Adair CD, Gunter M, Stovall TG et al. 1998. Chlamydia in pregnancy: A randomized trial of azithromycin and erythromycin. Obstet Gynecol 91:165-168.
  • Andersson NW, Olsen RH, Andersen JT. 2021. Association between use of macrolides in pregnancy and risk of major birth defects: nationwide, register based cohort study. BMJ. 372:n107.
  • Bahat Dinur A, et al. 2013. Fetal safety of macrolides. Antimicrob Agents Chemother 57(7):3307-11.
  • Berard A, et al. 2015. Use of macrolides during pregnancy and the risk of birth defects: a population-based study. Pharmacoepidemiol Drug Saf 24(12):1241-1248.
  • Cohen I, et al. 1990. Improved pregnancy outcome following successful treatment of chlamydial infection. JAMA 263:3160-3163.
  • Committee on Drugs, American Academy of Pediatrics. 2001. The transfer of drugs and other chemicals into human breast milk. Pediatrics 108:776-89.
  • Damkier P, et al. 2019. In utero exposure to antibiotics and risk of congenital malformations: A population-based study. Am J Obstet Gynecol 221:648.e1-15.
  • Fan H, et al. 2020. Associations between macrolide antibiotics prescribing during pregnancy and adverse child outcomes in the UK: population based cohort study. BMJ 368:m331.
  • Flenady V, et al. 2013. Prophylactic antibiotics for inhibiting preterm labour with intact membranes. Cochrane Database Syst Rev 5;12:CD000246.
  • FitzSimmons J et al. 1990. Chlamydial infections in pregnancy. J Reprod Med 31:19-22, 1986.
  • Goldstein LH, et al. 2009. The safety of macrolides during lactation. Breastfed Med 4:157-200
  • Källén B, Danielsson BR, 2014. Fetal safety of erythromycin. An update of Swedish data. Eur J Clin Pharmacol 70(3):355-60.
  • Lin KJ, et al. 2013. Safety of macrolides during pregnancy. Am J Obstet Gynecol 208(3):221.e1-8.
  • Lund M, et al. 2014. Use of macrolides in mother and child and risk of infantile hypertrophic pyloric stenosis: nationwide cohort study. BMJ 11;348:g1908.
  • Marlow N, et al. 2017. The ORACLE Children Study: educational outcomes at 11 years of age following antenatal prescription of erythromycin or co-amoxiclav. Arch Dis Child Fetal Neonatal Ed 102(2):F131-F135.
  • McCormack WM et al. 1987. Effect on birth weight of erythromycin treatment of pregnant women. Obstet Gynecol 69:202-207.
  • McGregor JA et al. 1986. Adjunctive erythromycin treatment for idiopathic preterm labor: Results of a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol 154:98-103.
  • Romøren M, et al. 2012. Pregnancy outcome after gestational exposure to erythromycin – a population-based register study from Norway. Br J Clin Pharmacol 74(6):1053-62.
  • Ryan GM Jr, Abdella TN, McNeeley SG, et al. 1990. Chlamydia trachomatis infection in pregnancy and effect of treatment on outcome. Am J Obstet Gynecol 162:34-39.
  • Sorensen, HT et al. 2003. Risk of infantile hypertrophic pyloric stenosis after maternal postnatal use of macrolides. Scand J Infect Dis 35:104-6
  • WHO Working Group, Bennet PN (ed). 1988. Drugs and Human Lactation. Elsevier, Amsterdam, New York, Oxford, pp. 253-4.
  • Schachter J et al. 1986. Experience with the routine use of erythromycin for chlamydial infections in pregnancy. N Engl J Med 314:276-9.


Proton Pump Inhibitors

Selected References:

  • Caballero Bermejo A, et al. 2020. Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial. Trials; 21(1):794. PMID: 32938496 PMCID: PMC7492787 DOI: 10.1186/s13063-020-04633-3
  • Khiali S, et al. 2021. A comprehensive review on sarilumab in COVID-19
  • Affiliations expand. Expert Opin Biol Ther; 21(5):615-626. PMID: 33161757 DOI: 10.1080/14712598.2021.1847269
  • Garcia-Vicuña R, et al. 2020. Subcutaneous Sarilumab in hospitalised patients with moderate-severe COVID-19 infection compared to the standard of care (SARCOVID): a structured summary of a study protocol for a randomised controlled trial. Trials; 21(1):772. PMID: 32907638 PMCID: PMC7480631 DOI: 10.1186/s13063-020-04588-5
  • No authors listed, 2020. Sarilumab. In: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006–.PMID: 29999974 Bookshelf ID: NBK500915. https://www.ncbi.nlm.nih.gov/books/NBK500915/ Accessed 01/2022.
  • Prieto-Peña D, et al. 2021. Biologic agents and small-molecule inhibitors in systemic autoimmune conditions: an update. Pol Arch Intern Med; 131(2):171-181. PMID: 32550671 DOI: 10.20452/pamw.1543


Proton Pump Inhibitors

Selected References:

  • Butler DC, et al. 2014. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol, 70(3):417 e1-10.
  • Carter TC, et al. 2008. Antifungal drugs and the risk of selected birth defects. Am J Obstet Gyn, 198:191- 193.
  • Czeizel AE, et al. 2004. Population-based case-control teratologic study of topical miconazole. Congenit Anom, 44:41-45.
  • Daniel S, et al. 2018. Vaginal antimycotics and the risk for spontaneous abortions. Am J Obstet Gynecol, 218(6):601.e1-601.e7.
  • Giavini E, Menegola E. 2010. Are azole fungicides a teratogenic risk for human conceptus? Toxicol Lett, 198(2):106-111.
  • Kazy Z, et al. 2005. The possible association between the combination of vaginal metronidazole and miconazole treatment and poly-syndactyly population-based case-control teratologic study. Reprod Toxicol, 20:89-94.
  • Mendling W, Brasch J. 2012. Guidelines vulvovaginal candidosis (2010) of the German Society for Gynecology and Obstetrics, the Working Group for Infections and Infectimmunology in Gynecology and Obstetrics, the German Society of Dermatology, the Board of German Dermatologists and German speaking Mycological Society. Mycoses, Jul (55) Suppl 3:1-13.
  • Murase JE, et al. 2014. Safety of dermatologic medications in pregnancy and lactation: Part 1 Pregnancy. J Am Acad Dermatol, 70(3):401.e1-14.
  • Rotem R, et al. 2018. Risk of major congenital malformations following first-trimester exposure to vaginal azoles used for treating vulvovaginal candidiasis: a population-based retrospective cohort study. BJOG, 125(12):1550-1556.
  • Soong D and Einarson A. 2009. Vaginal yeast infections during pregnancy. Can Fam Physician, 55(3):255-256.
  • Stevens RE, et al. 2002. Bioavailability study of a 1200 mg miconazole nitrate vaginal ovule in healthy female adults. J Clin Pharmacol, 42(1):52-60.
  • Tiboni GM et al. 2008. Teratogenic effects in mouse fetuses subjected to the concurrent in utero exposure to miconazole and metronidazole. Reprod Toxicol, 26(3-4):254-61.