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Infant Health and Neurodevelopmental Outcomes Following Prenatal Exposure to Duloxetine

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Abstract

Maternal psychiatric disorders can have negative consequences on the fetus and newborn. Thus, the risks of untreated mental disorders in pregnancy should be balanced against the potential risks of a psychopharmacological treatment. The aim of the present report is to provide information on the infant safety of duloxetine exposure, an antidepressant drug belonging to the serotonin–norepinephrine reuptake inhibitors, during pregnancy. Despite duloxetine being routinely prescribed as a treatment for major depression and anxiety disorders, there is a paucity of literature evaluating both the short- and long-term effects of duloxetine exposure in utero. This paper provides data on infant health and neurodevelopmental outcomes, up to 9 months of age, in a newborn exposed to duloxetine throughout pregnancy. Although the present report suggests that duloxetine was not associated with major malformations or neurobehavioural problems, the drug should be used with caution until further information is available on its safety profile in pregnancy.

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References

  1. Gartlehner G, Thaler K, Hansen RA, et al. The general and comparative efficacy and safety of duloxetine in major depressive disorder: a systematic review and meta-analysis. Drug Saf. 2009;32:1159–73.

    Article  PubMed  CAS  Google Scholar 

  2. Carter NJ, McCormack PL. Duloxetine: a review of its use in the treatment of generalized anxiety disorder. CNS Drugs. 2009;23(6):523–41.

    Article  PubMed  CAS  Google Scholar 

  3. Boyce PM, Hackett LP, Ilett KF. Duloxetine transfer across the placenta during pregnancy and into milk during lactation. Arch Womens Ment Health. 2011;14:169–72.

    Article  PubMed  Google Scholar 

  4. Briggs GG, Ambrose PJ, Ilett KF, et al. Use of duloxetine in pregnancy and lactation. Ann Pharmacother. 2009;43:1898–902.

    Article  PubMed  Google Scholar 

  5. Eyal R, Yaeger D. Poor neonatal adaptation after in utero exposure to duloxetine. Am J Psychiatry. 2008;165:651.

    Article  PubMed  Google Scholar 

  6. Rampono J, Simmer K, Ilett KF, et al. Placental transfer of SSRI and SNRI antidepressants and effects on the neonate. Pharmacopsychiatry. 2009;42:95–100.

    Article  PubMed  CAS  Google Scholar 

  7. Gentile S. On categorizing gestational, birth, and neonatal complications following late pregnancy exposure to antidepressants: the prenatal antidepressant exposure syndrome. CNS Spectr. 2010;15(3):167–85.

    PubMed  Google Scholar 

  8. Warburton W, Hertzman C, Oberlander TF. A register study of the impact of stopping third trimester selective serotonin reuptake inhibitor exposure on neonatal health. Acta Psychiatr Scand. 2010;121:471–9.

    Google Scholar 

  9. Tuccori M, Testi A, Antonioli L, et al. Safety concerns associated with the use of serotonin reuptake inhibitors and other serotonergic/noradrenergic antidepressants during pregnancy: a review. Clin Ther. 2009;31(Pt 1):1426–53.

    Article  PubMed  CAS  Google Scholar 

  10. Byatt N, Deligiannidis KM, Freeman MP. Antidepressant use in pregnancy: a critical review focused on risks and controversies. Acta Psychiatr Scand. 2013;127(2):94–114.

    Article  PubMed  CAS  Google Scholar 

  11. Batton E, Weigler K, Aylward G, et al. In utero antidepressant exposure and neurodevelopment in preterm infants. Am J Perinatal. 2013;30(4):297–302.

    Article  Google Scholar 

  12. Nulman I, Koren G, Rovet J, et al. Neurodevelopment of children following prenatal exposure to venlafaxine, selective serotonin reuptake inhibitors, or untreated maternal depression. Am J Psychiatry. 2012;169(11):1165–74.

    Article  PubMed  Google Scholar 

  13. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). American Psychiatric Association: Washington, DC; 2000.

  14. Dubowitz L, Ricciw D, Mercuri E. The Dubowitz neurological examination of the full-term newborn. Ment Retard Dev Disabil Res Rev. 2005;11(1):52–60.

    Article  PubMed  Google Scholar 

  15. Bayley N. Bayley Scales of infant and toddler development—third edition: technical manual. San Antonio: Harcourt Assessment; 2006.

    Google Scholar 

  16. Josse D. Brunet–Lezine Révisé: Échelle de Développement Psychomoteur de la Première Enfance. Paris: Etablissement d’Applications Psychotechniques; 1997.

    Google Scholar 

  17. Lezine I, Brunet O. Presentation of a French scale of tests for infants. Ann Med Psychol (Paris). 1950;108:499.

    CAS  Google Scholar 

  18. Field T, Diego M, Hernandez-Reif M. Prenatal depression effects on the fetus and newborn: a review. Infant Behav Dev. 2006;29:445–55.

    Article  PubMed  Google Scholar 

  19. Deave T, Heron J, Evans J, et al. The impact of maternal depression in pregnancy on early child development. BJOG. 2008;115:1043–51.

    Article  PubMed  CAS  Google Scholar 

  20. Grote NK, Bridge JA, Gavin AR, et al. A meta-analysis of depression during pregnancy and the risk of preterm birth, low birth weight, and intrauterine growth restriction. Arch Gen Psychiatry. 2010;67:1012–24.

    Article  PubMed  Google Scholar 

  21. Austin MP, Hadzi-Pavlovic D, Leader L, et al. Maternal trait anxiety, depression and life event stress in pregnancy: relationships with infant temperament. Early Hum Dev. 2005;81(2):183–90.

    Article  PubMed  Google Scholar 

  22. Bennett HA, Einarson A, Taddio A, et al. Depression during pregnancy. Overview of clinical factors. Clin Drug Investig. 2004;24(3):157–79.

    Article  PubMed  Google Scholar 

  23. Simoncelli M, Martin BZ, Bérard A. Antidepressant use during pregnancy: a critical systematic review of the literature. Curr Drug Saf. 2010;5(2):153–70.

    Article  PubMed  CAS  Google Scholar 

  24. Casper RC, Fleisher BE, Lee-Ancajas JC, et al. Follow-up of children of depressed mothers exposed or not exposed to antidepressant drugs during pregnancy. J Pediatr. 2003;142:402–8.

    Article  PubMed  CAS  Google Scholar 

  25. Einarson A, Smart K, Vial T, et al. Rates of major malformations in infant following exposure to duloxetine during pregnancy: a preliminary report. J Clin Psychiatry. 2012;73(11):1471.

    Article  PubMed  Google Scholar 

  26. Hoog SL, Cheng Y, Elpers J, et al. Duloxetine and pregnancy outcomes: safety surveillance findings. Int J Med Sci. 2013;10(4):413–9.

    Article  PubMed  CAS  Google Scholar 

  27. Barker ED, Copeland W, Maughan B, et al. Relative impact of maternal depression and associated risk factors on offspring psychopathology. Br J Psychiatry. 2012;200(2):124–9.

    Article  PubMed  Google Scholar 

  28. Davalos DB, Yadon CA, Tregellas HC. Untreated prenatal maternal depression and the potential risks to offspring: a review. Arch Womens Ment Health. 2012;15(1):1–14.

    Article  PubMed  Google Scholar 

  29. Spinelli M. Antidepressant treatment during pregnancy. Am J Psychiatry. 2012;169(2):121–4.

    Article  PubMed  Google Scholar 

  30. Stewart DE. Clinical practice. Depression during pregnancy. N Engl J Med. 2011;365(17):1605–11.

    Article  PubMed  CAS  Google Scholar 

  31. Lobo ED, Loghin C, Knadler MP, et al. Pharmacokinetics of duloxetine in breast milk and plasma of healthy postpartum women. Clin Pharmacokinet. 2008;47(2):103–9.

    Article  PubMed  CAS  Google Scholar 

  32. Gentile S, Galbally M. Prenatal exposure to antidepressant medications and neurodevelopmental outcomes: a systematic review. J Affect Disord. 2011;128(1–2):1–9.

    Article  PubMed  CAS  Google Scholar 

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Acknowledgments

No sources of funding were used to assist in the preparation of this case report. The authors have no conflicts of interest that are directly relevant to the content of this case report. The authors would like to thank the patient for participating in this trial.

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Authors and Affiliations

  1. Psychiatric Unit and DEGRA Centre, United Hospital of Ancona and Academic Department of Experimental and Clinical Medicine, Polytechnic University of Marche, Via Conca, 71, 60020, Ancona, Italy

    Cesario Bellantuono, Alessandra Marini & Chiara Lucarelli

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  1. Cesario Bellantuono
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  2. Alessandra Marini
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  3. Chiara Lucarelli
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Correspondence to Chiara Lucarelli.

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Bellantuono, C., Marini, A. & Lucarelli, C. Infant Health and Neurodevelopmental Outcomes Following Prenatal Exposure to Duloxetine. Clin Drug Investig 33, 685–688 (2013). https://doi.org/10.1007/s40261-013-0112-y

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