title: Olanzapine in pregnancy and breastfeeding: a review of data from global safety surveillance.
abstract: BACKGROUND
  Olanzapine use has been reported during pregnancy and breastfeeding, but there are no controlled clinical trials assessing the safety of olanzapine exposure to infants and fetuses. The purpose of this report was to review and analyze prospective post-marketing cases of pregnancy and breastfeeding with olanzapine, in order to guide clinicians and women on the use of olanzapine therapy during pregnancy and/or breastfeeding.
  
  
  METHODS
  A worldwide safety database maintained by Eli Lilly and Company was searched for all spontaneous-reported data regarding olanzapine use during pregnancy and/or breastfeeding. Cases reported prior to pregnancy outcome were considered to be prospective, and follow-up was pursued after the delivery date to assess outcome.
  
  
  RESULTS
  Outcome data were available for 610 prospectively identified pregnancies during which olanzapine was used. The majority of women had normal births (66%), although premature births were reported in 9.8% and perinatal conditions in 8% of the pregnancies. A total of 102 pregnancies reported olanzapine treatment during breastfeeding. In these infants, the most commonly reported adverse events were somnolence (3.9%), irritability (2%), tremor (2%), and insomnia (2%), although the majority of pregnancies reported no adverse events (82.3%).
  
  
  CONCLUSIONS
  The frequency of fetal outcomes in these prospectively identified pregnancies exposed to olanzapine did not differ from rates of outcomes reported in the general population. These data may be useful to help guide clinicians and women decide to continue, or discontinue, olanzapine therapy during pregnancy and/or breastfeeding, but should be considered within the limitations associated with spontaneously reported data. Women should notify their clinicians if they become pregnant or intend to become pregnant while being treated with olanzapine. Because of limited experience in humans, olanzapine should be used in pregnancy only when potential benefit justifies potential risk to the fetus. Olanzapine should only be considered during breastfeeding when the potential benefit justifies the potential risk to the infant.
authors.affiliation: Lilly Corporate Center, Eli Lilly and Company, Indianapolis, Indiana 46285, USA. ebrunner@lilly.com
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Brunner
authors.forename: Deborah M
authors.initials: DM
authors.lastname: Falk
authors.forename: Meghan
authors.initials: M
authors.lastname: Jones
authors.forename: Debashish K
authors.initials: DK
authors.lastname: Dey
authors.forename: Chetan Chinmaya
authors.initials: CC
authors.lastname: Shatapathy
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000627:therapeutic use*; D001942:Breast Feeding; D016208:Databases, Factual; D005260:Female; D006801:Humans; D000077152:Olanzapine; D060735:Pharmacovigilance; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology*
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D000077152:Olanzapine
references.citation: BMJ. 2006 Sep 30;333(7570):679
references.pmid: 16893903
references.citation: Natl Vital Stat Rep. 2008 Apr 14;56(15):1-25, 28
references.pmid: 18578105
references.citation: Natl Vital Stat Rep. 2009 Jan 28;57(8):1-19
references.pmid: 19294965
references.citation: J Clin Psychiatry. 2009 Feb;70(2):247-58
references.pmid: 19210948
references.citation: Lancet. 1999 Nov 13;354(9191):1700-1
references.pmid: 10568577
references.citation: Clin Exp Pharmacol Physiol. 1999 Sep;26(9):691-7
references.pmid: 10499158
references.citation: Am J Psychiatry. 2007 Nov;164(11):1759-60
references.pmid: 17974944
references.citation: Schizophr Bull. 2010 May;36(3):518-44
references.pmid: 18787227
references.citation: N Engl J Med. 1998 Apr 16;338(16):1128-37
references.pmid: 9545362
references.citation: J Wound Ostomy Continence Nurs. 2008 Jul-Aug;35(4):391-4; quiz 395-6
references.pmid: 18635987
references.citation: MMWR Morb Mortal Wkly Rep. 1995 Jan 27;44(3):46-8
references.pmid: 7823895
references.citation: Clin Ther. 1998;20 Suppl C:C40-4
references.pmid: 9915089
references.citation: Am J Psychiatry. 2007 Aug;164(8):1214-20
references.pmid: 17671284
references.citation: Am J Psychiatry. 2005 Jan;162(1):79-91
references.pmid: 15625205
references.citation: Br J Psychiatry. 2008 May;192(5):333-7
references.pmid: 18450655
references.citation: Int J Gynaecol Obstet. 2002 Aug;78(2):179-90
references.pmid: 12360906
references.citation: Int J Psychiatry Med. 2003;33(4):391-4
references.pmid: 15152788
references.citation: Eur Psychiatry. 2006 Jul;21(5):345-6
references.pmid: 16545547
references.citation: Obstet Gynecol. 2005 May;105(5 Pt 1):1052-7
references.pmid: 15863544
references.citation: Am J Psychiatry. 2007 Oct;164(10):1547-56
references.pmid: 17898346
references.citation: Arch Womens Ment Health. 2006 Jul;9(4):219-22
references.pmid: 16755330
references.citation: NCHS Data Brief. 2009 Apr;(16):1-8
references.pmid: 19389328
references.citation: Br J Psychiatry. 2001 May;178:427-32
references.pmid: 11331558
references.citation: Drug Saf. 2007;30(3):247-64
references.pmid: 17343431
references.citation: Am J Psychiatry. 2003 Aug;160(8):1428-31
references.pmid: 12900304
references.citation: J Am Acad Child Adolesc Psychiatry. 2009 Jan;48(1):60-70
references.pmid: 19057413
references.citation: J Psychopharmacol. 2010 Jan;24(1):121-3
references.pmid: 18801835
references.citation: Psychopharmacology (Berl). 1996 Mar;124(1-2):159-67
references.pmid: 8935812
references.citation: Ther Drug Monit. 2008 Jun;30(3):399-401
references.pmid: 18520614
references.citation: Breastfeed Med. 2011 Apr;6(2):55-8
references.pmid: 21034242
references.citation: Pharmacol Biochem Behav. 2002 Jun;72(3):575-9
references.pmid: 12175454
references.citation: Drug Saf. 2004;27(6):353-67
references.pmid: 15144230
references.citation: Int J Neuropsychopharmacol. 2002 Sep;5(3):243-7
references.pmid: 12366877
references.citation: J Clin Psychiatry. 2005 Mar;66(3):317-22
references.pmid: 15766297
references.citation: J Clin Psychiatry. 2005 Apr;66(4):444-9; quiz 546
references.pmid: 15816786
references.citation: Psychiatr Danub. 2008 Mar;20(1):88-90
references.pmid: 18376337
references.citation: MMWR Morb Mortal Wkly Rep. 2008 Jan 11;57(1):1-5
references.pmid: 18185492
references.citation: Lancet. 2005 Aug 13-19;366(9485):583-91
references.pmid: 16099295
references.citation: BJOG. 2008 May;115(6):681-8
references.pmid: 18410650
references.citation: Natl Vital Stat Rep. 2009 Apr 17;57(14):1-134
references.pmid: 19788058
references.citation: J Affect Disord. 2001 Dec;67(1-3):133-40
references.pmid: 11869760