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Maternal Use of Antiviral Drugs, Immune Globulins, or Vaccines and Infant Congenital Malformations

  • Bengt Källén
Chapter

Abstract

There are very few signs of teratogenicity of antiviral drugs but further data are needed on specific drugs, notably on antiretroviral drugs. An observed association between use of zidovudine and infant hypospadias needs verification. Dolutegravir should if possible be avoided until the suspected association with neural tube defects has been clarified. Immune globulins can be used without risk during pregnancy. Vaccinations—notably based on living virus—should, if possible, be avoided during the first trimester but if inadvertent use occurs the risk of malformations is low.

References

  1. Avalos LA, Chen H, Yang C, Andrade SE, Cooper WO, Cheetham CT, Davis RL, Dublin S, Hammad TA, Kaplan S, Pawloski PA, Raebel MA, Scott PE, Smith DH, Toh S, Li D-K. The prevalence and trends of antiviral medication use during pregnancy in the U.S.A. A population-based study of 664,297 deliveries in 2001-2007. Matern Child Health J. 2014;18:64–72.  https://doi.org/10.1007/s10995-013-1234-9.CrossRefPubMedGoogle Scholar
  2. Badell ML, Meaney-Delman D, Methodius G, Tuuli G, Rasmussen SA, Petersen BW, Sheffield JS, Belgi RH, Damon IK, Jamieson DJ. Risks associated with smallpox vaccination in pregnancy: a systematic review and meta-analysis. Obstet Gynecol. 2015;125:1439–51.CrossRefGoogle Scholar
  3. Badilla X, Morice A, Avila-Aquero ML, Saenz E, Cerda I, Reef S, Castillo-Solórzano C. Fetal risk associated with rubella vaccination during pregnancy. Pediatr Infect Dis J. 2007;26:830–5.CrossRefGoogle Scholar
  4. Bar-Oz B, Levichek Z, Moretti ME, Mah C, Andreou S, Koren G. Pregnancy outcome following rubella vaccination: a prospective controlled study. Am J Med Genet A. 2004;130A:52–4.CrossRefGoogle Scholar
  5. Bérard A, Sheehy O, Zhao JP, Abrahamowicz M, Loutfy M, Boucoiran I, Bernatsky S. Antiretroviral combination use during pregnancy and the risk of major congenital malforomations. AIDS. 2017;31:2267–77.CrossRefGoogle Scholar
  6. Castillo-Solórzano C, Reef SE, Morice A, Vascones N, Chevez AE, Castalia-Soares R, Torres C, Vizzotti C, Ruiz Matus C. Rubella vaccination of unknowingly pregnant women during mass campaigns for rubella and rubella syndrome elimination, the 2001-2008. J Infect Dis. 2011;204(Suppl):713–7.CrossRefGoogle Scholar
  7. Chambers, Johnson D, Xu R, Luo C, Mitchell AA, Schatz M, Jones KL, OTIS Collaborative Research Group. Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: birth defects, spontaneous abortion, preterm delivery and small for gestational age infants. Vaccine. 2013;31:6026–32.CrossRefGoogle Scholar
  8. Conlin AMS, Sevick CJ, Gumbs GR, Khodr ZG, Bukowinski AT. Safety of inadvertent anthrax vaccination during pregnancy: an analysis of birth defects in the U.S. military population, 2003-2010. Vaccine. 2017;35:4414–20.CrossRefGoogle Scholar
  9. Czeizel AE, Rockenbauer M. Tetanus toxoid and congenital abnormalities. Int J Gynecol Obstet. 1999;199(64):253–8.CrossRefGoogle Scholar
  10. Dana A, Buchanan KM, Goss MA, Seminack MM, Shields KE, Koen S, Cunnninghman ML, Haupt RM. Pregnancy outcome from the pregnancy registry of a human papillomavirus type 6/11/16/18 vaccine. Obstet Gynecol. 2009;114:1170–8.CrossRefGoogle Scholar
  11. Ergenoğlu AM, Yeniel AO, Yildirim N, Kazandi M, Akercan F, Sağoi S. Rubella vaccination during the preconception period or in pregnancy and perinatal and fetal outcome. Turk J Pediatr. 2012;54:230–3.PubMedGoogle Scholar
  12. Fabiani M, Bella A, Rota MC, Clagan E, Gallo T, D’Amato M, Pezzotti P, Ferrara L, Demicheli V, Martinelli D, Prato R, Rizzo C. A/H1N1 pandemic influenza vaccination: a retrospective evaluation of adverse maternal, fetal and neonatal outcomes in a cohort of pregnant women in Italy. Vaccine. 2015;33(19):2240–7.CrossRefGoogle Scholar
  13. Goss MA, Lievano F, Buchanan KM, Seminack MM, Cunningham ML, Dana A. Final report on exposure during pregnancy from a pregnancy registry for quadrivalent human papilloma vaccine. Vaccine. 2015;26:3422–8.CrossRefGoogle Scholar
  14. Graner S, Svensson T, Beau A-B, Damase-Michel C, Engeland A, Furu K, Hviid A, Eldevik Håberg S, Mølgaard-Nielsen D, Pasternak B, Kieler H. Neuraminidase inhibitors during pregnancy and risk of adverse neonatal outcomes and congenital malformations: population based European register study. BMJ. 2017;356:j629.  https://doi.org/10.1136/bmj.j629.CrossRefPubMedPubMedCentralGoogle Scholar
  15. Grout L, Martinez-Pino I, Ciglenecki I, Kelta S, Diallo AA, Traore B, Delamou D, Toure O, Nicholas S, Rusch B, Straderini N, Serafini M, Grais RF, Luquero FJ. Pregnancy outcomes after a mass vaccination campaign with an oral cholera vaccine in Guinea: a retrospective cohort study. PLoS Negl Trop Dis. 2015;9:e0004274.  https://doi.org/10.1371/journal.pntd.0004274.CrossRefPubMedPubMedCentralGoogle Scholar
  16. Harjulehto-Mervaala T, Aro T, Hillesmaa VK, Saxén H, Hovi T, Saxén L. Oral polio vaccination during pregnancy: no increase in the occurrence of congenital malformations. Am J Epidemiol. 1993;138:407–14.CrossRefGoogle Scholar
  17. Källén B, Olausson PO. Vaccination against H1N1 influenza with Pandemrix® during pregnancy and delivery outcome: a Swedish register study. BJOG. 2012;119:1583–90.CrossRefGoogle Scholar
  18. Kumar RM, Hughes PF, Khuranna A. Zidovudine use in pregnancy: a report on 104 cases and the occurrence of birth defects. J Acquir Immune Defic Syndr. 1994;7:1034–9.PubMedGoogle Scholar
  19. Lipkind HS, Vazquez-Benitez G, Nordin JD, Romitti PA, Naleway AL, Klein NP, Hechter RC, Jackson ML, Hambidge SJ, Lee GM, Sukumaran L, Kharbanda EO. Maternal and infant outcomes after human papillomavirus vaccination in the perticonceptional period or during pregnancy. Obstet Gynecol. 2017;130:599–608.CrossRefGoogle Scholar
  20. Liu M, Cai H, Yi W. Safety of telbivudine treatment for chronic hepatitis B for the entire pregnancy. J Viral Hepat. 2013;20(Suppl 1):65–70.  https://doi.org/10.1111/jvh.12066.CrossRefPubMedGoogle Scholar
  21. Minakami H, Kubo T, Nakai A, Saito S, Unno N. Pregnancy outcomes of women exposed to laninamivir during pregnancy. Pharmacoepidemiol Drug Saf. 2014;23:1084–7.CrossRefGoogle Scholar
  22. Minussi L, Mohrdiech R, Bercini M, Sanseverino MT, Momino W, Callegari-Jaques SM, Schuler-Faccini L. Prospective evaluation of pregnant women vaccinated against rubella in southern Brazil. Reprod Toxicol. 2008;25:120–3.CrossRefGoogle Scholar
  23. Namael MH, Ziaee M, Naseh N. Congenital rubella syndrome in infants of women vaccinated during or just before pregnancy with measles-rubella vaccine. Indian J Med Res. 2008;127:551–4.Google Scholar
  24. Nasiri R, Yoseffi J, Khajedaloe M, Sarafraz Yazdi M, Delgoshaei F. Congenital rubella syndrome after rubella vaccination in 1-4 weeks periconceptional period. Indian J Pediatr. 2009;76:279–82.CrossRefGoogle Scholar
  25. Newschaffer CJ, Cocroft J, Anderson CE, Hauck WW, Turner BJ. Prenatal zidovudine use and congenital anomalies in a Medicaid population. J Acquir Immune Defic Syndr. 2000;24:249–56.CrossRefGoogle Scholar
  26. Pasternak B, Hviid A. Use of acyclovir, valacyclovir, and famciclovir in the first trimester of pregnancy and the risk of birth defects. JAMA. 2010;304:859–66.CrossRefGoogle Scholar
  27. Pasternak B, Svanström H, Mølgaard-Nielsen D, Krause TG, Emborg HD, Melbye M, Hviid A. Risk of adverse fetal outcomes following administration of a pandemic influenza A(H1N1) vaccine during pregnancy. JAMA. 2012;308:165–74.CrossRefGoogle Scholar
  28. Phiri K, Hernandez-Diaz S, Dugan KB, Williams PL, Dudley JA, Jules A, Callahan ST, Seage GR 3rd, Cooper WO. First trimester exposure to antiretroviral therapy and risk of birth defccts. Pediatr Infect Dis J. 2014;33:741–6.CrossRefGoogle Scholar
  29. Pierce M, Kuribczuk JJ, Spark P, Brocklehurst P, Knight M, ön behalf of UKOSS. Perinatal outcome after maternal 2009/H1N1 infection: national cohort study. BMJ. 2011;342:d3214.  https://doi.org/10.1136/bmj.d3214.CrossRefPubMedPubMedCentralGoogle Scholar
  30. Preblud SR, Stetler HC, Frank JA Jr, Greaves WL, Hinman AR, Herrmann KL. Fetal risk associated with rubella vaccine. JAMA. 1981;246:1413–7.CrossRefGoogle Scholar
  31. Ratanajamit C, Vinther Skriver M, Jepsen P, Chongsuviva V, Olsen J, Sørensen HT. Adverse pregnancy outcome in women exposed to acyclovir during pregnancy: a population-based observational study. Scand J Infect Dis. 2003;35:255–9.CrossRefGoogle Scholar
  32. Ryan MA, Gumbs GR, Conlin AM, Sevick CJ, Jacobson IG, Snell KJ, Spooner CN, Smith TC. Evaluation of preterm births and birth defects in liveborn infants of US military women who received smallpox vaccine. Birth Defects Res A Clin Mol Teratol. 2008a;82:533–9.CrossRefGoogle Scholar
  33. Ryan MA, Smith TC, Sevick CJ, Honner WK, Loach RA, Moore CA, Erickson JD. Birth defects among infants born to women who received anthrax vaccine in pregnancy. Am J Epidemiol. 2008b;168:434–42.CrossRefGoogle Scholar
  34. Scheller NM, Pasternak B, Mølgaard-Nielsen S, Svanström H, Hviid A. Quadrivalent HPV vaccination and the risk of adverse pregnancy outcome. N Engl J Med. 2017;376:1223–33.CrossRefGoogle Scholar
  35. Stone KM, Reiff-Eldridge R, White AD, Cordero JF, Brown Z, Alexander ER, Andrews EB. Pregnancy outcomes following systemic prenatal acyclovir exposure: conclusions from the International Acyclovir Pregnancy Registry, 1984-1999. Birth Defects Res A Clin Mol Teratol. 2004;70:201–7.CrossRefGoogle Scholar
  36. Suzano CES, Amaral E, Sato HK, Papaiordanou PM. The effects of yellow fever immunization (17DD) inadvertently used in early pregnancy during a mass campaign in Brazil. Vaccine. 2006;24:1421–6.CrossRefGoogle Scholar
  37. Svensson T, Granath F, Stephanson O, Kieler H. Birth outcomes among women exposed to neuraminidase inhibitors during pregnancy. Pharmacoepidemiol Drug Saf. 2011;20:1030–4.CrossRefGoogle Scholar
  38. Trotta F, Da Cas R, Alegiani SS, Gramegna M, Venegoni M, Zocchetti C, Traversa G. Evaluation of the safety of A/H1N1 pandemic vaccination during pregnancy: cohort study. BMJ. 2014;348:g3361.  https://doi.org/10.1136/bmj.g3361.CrossRefPubMedPubMedCentralGoogle Scholar
  39. Watts DH, Covington DL, Beckerman K, Garcia P, Scheuerle A, Dominguez K, Ross B, Sarks S, Chavers S, Tilson H. Assessing the risk of birth defects associated with antiretroviral exposure during pregnancy. Am J Obstet Gynecol. 2004;191:985–92.CrossRefGoogle Scholar
  40. Watts DH, Li D, Handelsman E, Tilson H, Paul M, Foca M, Vajaranant M, Diaz C, Tuomala R, Thompson B. Assessment of birth defects according to maternal therapy among infants in the Women and Infants Transmission Study. J Acquir Immune Defic Syndr. 2007;44:299–305.CrossRefGoogle Scholar
  41. White A, Eldridge R, Andrews E. Birth outcomes following zidovudine exposure in pregnant women; the Antiretroviral Pregnancy Registry. Acta Paediatr Suppl. 1997;421:86–8.CrossRefGoogle Scholar
  42. Wilson E, Goss MA, Marin M, Shields KE, Seward JE, Rasmussen SA, Sharrar RG. Varicella vaccine exposure during pregnancy: data from 10 years of the pregnancy register. J Infect Dis. 2008;197(Suppl 2):178–84.CrossRefGoogle Scholar
  43. Yi W, Li M, Cal H-D. Safety of lamivudine treatment for chronic hepatitis B in early pregnancy. World J Gastroenterol. 2012;18:6645–50.CrossRefGoogle Scholar
  44. Zach R, Makhenon J, Shapiro RL. Neural-tube defects with dolutegravir treatment from the time of conception. N Engl J Med. 2018;379:979–81.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Bengt Källén
    • 1
  1. 1.Tornblad Institute for Comparative EmbryologyLund UniversityLundSweden

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