Paliperidone and pregnancy—an evaluation of the German Embryotox database

  • Marlies Onken
  • Inge Mick
  • Christof Schaefer
Original Article


Schizophrenic or schizoaffective disorders often occur in early adulthood and thus affect women of childbearing age. For paliperidone information about reproductive safety is wanting. Therefore, we evaluated data from the German Embryotox pharmacovigilance institute regarding paliperidone therapy during pregnancy. The German Embryotox pharmacovigilance institute offers risk assessment on drug use in pregnancy and documents the outcome of more than 3500 drug-exposed pregnancies per year. In our study, we analyze the outcome of all pregnancies with paliperidone exposure, which have been assessed by our institute between January 2007 and June 2016. Of the 17 prospectively assessed pregnancies, 14 resulted in 15 live-born children (including one pair of twins). None of the infants presented with major congenital malformations. There were two spontaneous abortions at gestational weeks 6 and 11, respectively, and one elective termination due to personal reasons. Sixty-five percent of the pregnant women smoked cigarettes throughout pregnancy, 17% consumed alcohol. Five children were born prematurely (< 37 gestational weeks) and four were small for gestational age, each group including the twins. The results of our study suggest that paliperidone may be administered during pregnancy. The increased rate of prematurity and small for gestational age children can at least partially be explained by other risk factors. Psychiatric and obstetric close monitoring as well as additional medical and social support are recommended to ensure a healthy pregnancy course in patients with a severe mental illness.


Antipsychotics Congenital malformation Paliperidone Pregnancy 



This work was financially supported by the German Federal Institute for Drugs and Medical Devices (BfArM). The data herein has been previously published in abstract form at the European Network of Teratology Information Services (ENTIS) conference in Budapest on September 3, 2017. We would like to thank all colleagues from the Berlin Institute for counseling patients and their physicians and thoroughly documenting cases.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.


  1. Densler JF (1977) Umbilical hernia in infants and children. J Natl Med Assoc 69:897PubMedPubMedCentralGoogle Scholar
  2. Habermann F, Fritzsche J, Fuhlbruck F, Wacker E, Allignol A, Weber-Schoendorfer C, Meister R, Schaefer C (2013) Atypical antipsychotic drugs and pregnancy outcome: a prospective, cohort study. J Clin Psychopharmacol 33:453–462CrossRefPubMedGoogle Scholar
  3. Huybrechts KF, Hernandez-Diaz S, Patorno E, Desai RJ, Mogun H, Dejene SZ, Cohen JM, Panchaud A, Cohen L, Bateman BT (2016) Antipsychotic use in pregnancy and the risk for congenital malformations. JAMA Psychiatry 73:938–946CrossRefPubMedPubMedCentralGoogle Scholar
  4. Jablensky AV, Morgan V, Zubrick SR, Bower C, Yellachich LA (2005) Pregnancy, delivery, and neonatal complications in a population cohort of women with schizophrenia and major affective disorders. Am J Psychiatry 162:79–91CrossRefPubMedGoogle Scholar
  5. Judd F, Komiti A, Sheehan P, Newman L, Castle D, Everall I (2014) Adverse obstetric and neonatal outcomes in women with severe mental illness: to what extent can they be prevented? Schizophr Res 157:305–309CrossRefPubMedGoogle Scholar
  6. Kallen B, Borg N, Reis M (2013) The use of central nervous system active drugs during pregnancy. Pharmaceuticals (Basel) 6:1221–1286CrossRefGoogle Scholar
  7. McKenna K, Koren G, Tetelbaum M, Wilton L, Shakir S, Diav-Citrin O, Levinson A, Zipursky RB, Einarson A (2005) Pregnancy outcome of women using atypical antipsychotic drugs: a prospective comparative study. J Clin Psychiatry 66:444–449 quiz 546CrossRefPubMedGoogle Scholar
  8. Miller LJ (1997) Sexuality, reproduction, and family planning in women with schizophrenia. Schizophr Bull 23:623–635CrossRefPubMedGoogle Scholar
  9. Ozdemir AK, Pak SC, Canan F, Gecici O, Kuloglu M, Gucer MK (2015) Paliperidone palmitate use in pregnancy in a woman with schizophrenia. Arch Womens Ment Health 18:739–740CrossRefPubMedGoogle Scholar
  10. Schaefer C, Ornoy A, Clementi M, Meister R, Weber-Schoendorfer C (2008) Using observational cohort data for studying drug effects on pregnancy outcome—methodological considerations. Reprod Toxicol 26:36–41CrossRefPubMedGoogle Scholar
  11. Schleussner E (2013) The prevention, diagnosis and treatment of premature labor. Dtsch Arztebl Int 110:227–235 quiz 36PubMedPubMedCentralGoogle Scholar
  12. Vigod SN, Dennis CL, Kurdyak PA, Cairney J, Guttmann A, Taylor VH (2014) Fertility rate trends among adolescent girls with major mental illness: a population-based study. Pediatrics 133:e585–e591CrossRefPubMedGoogle Scholar
  13. Virtanen HE, Toppari J (2008) Epidemiology and pathogenesis of cryptorchidism. Hum Reprod Update 14:49–58CrossRefPubMedGoogle Scholar
  14. World Medical Association (2013) World medical association declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 310:2191–2194Google Scholar
  15. Wunderink L, Nieboer RM, Wiersma D, Sytema S, Nienhuis FJ (2013) Recovery in remitted first-episode psychosis at 7 years of follow-up of an early dose reduction/discontinuation or maintenance treatment strategy: long-term follow-up of a 2-year randomized clinical trial. JAMA Psychiatry 70:913–920CrossRefPubMedGoogle Scholar
  16. Zamora Rodriguez FJ, Benitez Vega C, Sanchez-Waisen Hernandez MR, Guisado Macias JA, Vaz Leal FJ (2017) Use of Paliperidone palmitate throughout a schizoaffective disorder Patient’s gestation period. Pharmacopsychiatry 50:38–40PubMedGoogle Scholar

Copyright information

© Springer-Verlag GmbH Austria, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Charité Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Institut für Klinische Pharmakologie und ToxikologieBerlinGermany

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