The Basics
What is Olanzapine?
Used to treat bipolar disorder.
Brand names for Olanzapine
Zyprexa, Zyprexa Zydis
How Olanzapine is classified
Antipsychotic Agents
Olanzapine During Pregnancy
Olanzapine pregnancy category
Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Olanzapine while pregnant
Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with ZYPREXA. Advise patients that ZYPREXA may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZYPREXA during pregnancy [see Use In Specific Populations].
Taking Olanzapine While Breastfeeding
What are recommendations for lactation if you're taking Olanzapine?
Maternal doses of olanzapine up to 20 mg daily produce low levels in milk and undetectable levels in the serum of breastfed infants. In most cases, short-term side effects have not been reported, but sedation has occurred. Limited long-term follow-up of infants exposed to olanzapine indicates that infants generally developed normally. Systematic reviews of second-generation antipsychotics concluded that olanzapine seemed to be a first-line agent during breastfeeding.[1][2] Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.
Maternal / infant drug levels
Maternal doses of olanzapine up to 20 mg daily produce low levels in milk and undetectable levels in the serum of breastfed infants. In most cases, short-term side effects have not been reported, but sedation has occurred. Limited long-term follow-up of infants exposed to olanzapine indicates that infants generally developed normally. Systematic reviews of second-generation antipsychotics concluded that olanzapine seemed to be a first-line agent during breastfeeding.[1][2] Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.
Possible effects of Olanzapine on milk supply
Unlike the phenothiazines, olanzapine has a minimal effect on serum prolactin levels.[18][19][20][21][22] However, olanzapine-induced hyperprolactinemia and galactorrhea have been reported rarely. One patient was also taking venlafaxine and interferon beta-1b which can increase serum prolactin; however, galactorrhea began only after olanzapine was started.[23]
In 2 studies, some patients who were taking a conventional antipsychotic agent or risperidone had their medication changed to olanzapine. Previously elevated prolactin levels normalized and galactorrhea diminished or stopped.[22][24]
The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Possible alternatives to Olanzapine
Haloperidol, Quetiapine, Risperidone.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Uguz F. Second-generation antipsychotics during the lactation period: A comparative systematic review on infant safety. J Clin Psychopharmacol. 2016;36:244-52. PMID: 27028982
2. Pacchiarotti I, Leon-Caballero J, Murru A et al. Mood stabilizers and antipsychotics during breastfeeding: Focus on bipolar disorder. Eur Neuropsychopharmacol. 2016;26:1562-78. PMID: 27568278
3. Ambresin G, Berney P, Schulz P et al. Olanzapine excretion into breast milk: a case report. J Clin Psychopharmacol. 2004;24(1):93-5. Letter. PMID: 14709955
4. Croke S, Buist, Hackett LP et al. Olanzapine excretion in human breast milk: estimation of infant exposure. Int J Neuropsychopharmacol. 2003;5:243-7. PMID: 12366877
5. Gardiner SJ, Kristensen JH, Begg EJ et al. Transfer of olanzapine in to breast milk, calculation of infant drug dose, and effect on breast-fed infants. Am J Psychiatry. 2003;160:1428-31. PMID: 12900304
6. Lutz UC, Wiatr G, Orlikowsky T et al. Olanzapine treatment during breast feeding: a case report. Ther Drug Monit. 2008;30:399-401. PMID: 18520614
7. Whitworth A, Stuppaeck C, Yazdi K et al. Olanzapine and breast-feeding: changes of plasma concentrations of olanzapine in a breast-fed infant over a period of 5 months. J Psychopharmacol. 2008;99:379-83. PMID: 18801835
8. Var L, Ince I, Topuzoglu A, Yildiz A. Management of postpartum manic episode without cessation of breastfeeding: A longitudinal follow up of drug excretion into breast milk. Eur Neuropsychopharmacol. 2013;23 (Suppl 2):S382. Abstract.
9. Stiegler A, Schaletzky R, Walter G et al. Olanzapine treatment during pregnancy and breastfeeding: A chance for women with psychotic illness? Psychopharmacology (Berl). 2014;231:3067-9. PMID: 24938920
10. Aydin B, Nayir T, Sahin S, Yildiz A. Olanzapine and quetiapine use during breastfeeding: Excretion into breast milk and safe breastfeeding strategy. J Clin Psychopharmacol. 2015;35:206-8. PMID: 25679127
11. Manouilenko I, Ohman I, Georgieva J. Long-acting olanzapine injection during pregnancy and breastfeeding: A case report. Arch Womens Ment Health. 2018;21:587-9. PMID: 29637404
12. Kirchheiner J, Berghofer A, Bolk-Weischedel D. Healthy outcome under olanzapine treatment in a pregnant woman. Pharmacopsychiatry. 2000;33:78-80. PMID: 10761825
13. Brunner E, Falk DM, Jones M et al. Olanzapine in pregnancy and breastfeeding: a review of data from global safety surveillance. BMC Pharmacol Toxicol. 2013;14:38. PMID: 23902726
14. Friedman SH, Rosenthal MB. Treatment of perinatal delusional disorder: a case report. Int J Psychiatry Med. 2003;33(4):391-4. PMID: 15152788
15. Gilad O, Merlob P, Stahl B, Klinger G. Outcome of infants exposed to olanzapine during breastfeeding. Breastfeed Med. 2011;6:55-8. PMID: 21034242
16. Uguz F. Breastfed infants exposed to combined antipsychotics: Two case reports. Am J Ther. 2016;23:e1962-4. PMID: 26539905
17. Uguz F. Prophylactic use of olanzapine and quetiapine from pregnancy to the postpartum period in women with bipolar disorder: A case series. J Matern Fetal Neonatal Med. 2017;30:2569-71. PMID: 27809629
18. Crawford AM, Beasley CM Jr, Tollefson GD. The acute and long-term effect of olanzapine compared with placebo and haloperidol on serum prolactin concentrations. Schizophr Res. 1997;26(1):41-54. PMID: 9376336
19. Maguire GA. Prolactin elevation with antipsychotic medications: mechanisms of action and clinical consequences. J Clin Psychiatry. 2002;63(suppl 4):56-62. PMID: 11913677
20. Bergemann N, Mundt C, Parzer P et al. Plasma concentrations of estradiol in women suffering from schizophrenia treated with conventional versus atypical antipsychotics. Schizophr Res. 2005;73:357-66. PMID: 15653282
21. Weiden PJ, Daniel DG, Simpson G, Romano SJ. Improvement in indices of health status in outpatients with schizophrenia switched to ziprasidone. J Clin Psychopharmacol. 2003;23:595-600. PMID: 14624190
22. Kim KS, Pae CU, Chae JH et al. Effects of olanzapine on prolactin levels of female patients with schizophrenia treated with risperidone. J Clin Psychiatry. 2002;63:408-13. PMID: 12019665
23. Miller DE, Sebastian CS. Olanzapine-induced hyperprolactinemia and galactorrhea reversed with addition of bromocriptine: a case report. J Clin Psychiatry. 2005;66:269-70. PMID: 15705020
24. Kinon BJ, Ahl J, Liu-Seifert H, Maguire GA. Improvement in hyperprolactinemia and reproductive comorbidities in patients with schizophrenia switched from conventional antipsychotics or risperidone to olanzapine. Psychoneuroendocrinology. 2006;31:577-88. PMID: 16488084
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
