The Basics
What is Clozapine?
Anti-psychotic medication that works by helping to restore the balance of certain neurotransmitters in the brain.
Brand names for Clozapine
Clozaril
How Clozapine is classified
Antipsychotic Agents
Clozapine During Pregnancy
Clozapine pregnancy category
Category BNote 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 Clozapine while pregnant
N/A
Taking Clozapine While Breastfeeding
What are recommendations for lactation if you're taking Clozapine?
Because there is little published experience with clozapine during breastfeeding, and sedation and adverse hematologic effects have been reported in breastfed infants, other agents are preferred.[1] If breastfeeding is undertaken by a mother who is taking clozapine, close monitoring of the infant for excessive sedation and periodic monitoring of the infant’s white blood cell count is advisable. Several authoritative sources recommend that women taking clozapine not breastfeed.[2][3][4]
Maternal / infant drug levels
Because there is little published experience with clozapine during breastfeeding, and sedation and adverse hematologic effects have been reported in breastfed infants, other agents are preferred.[1] If breastfeeding is undertaken by a mother who is taking clozapine, close monitoring of the infant for excessive sedation and periodic monitoring of the infant’s white blood cell count is advisable. Several authoritative sources recommend that women taking clozapine not breastfeed.[2][3][4]
Possible effects of Clozapine on milk supply
Unlike the phenothiazines, clozapine has a minimal effect on maternal serum prolactin levels.[9][10] However, a woman who had been taking clozapine plus high-dose haloperidol developed hyperprolactinemia and severe galactorrhea 2 weeks after stopping haloperidol and 4 days after starting valproic acid. A dose of cabergoline normalized her serum prolactin and galactorrhea ceased for the following 2 months of observation.[11]
The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Possible alternatives to Clozapine
Haloperidol, Olanzapine, 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. Hasan A, Falkai P, Wobrock T et al. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Schizophrenia. Part 3: Update 2015 Management of special circumstances: Depression, Suicidality, substance use disorders and pregnancy and lactation. World J Biol Psychiatry. 2015;16:142-70. PMID: 25822804
3. 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
4. McAllister-Williams RH, Baldwin DS, Cantwell R et al. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum 2017. J Psychopharmacol. 2017;31:519-52. PMID: 28440103
5. Barnas C, Bergant A, Hummer M et al. Clozapine concentrations in maternal and fetal plasma, amniotic fluid, and breast milk. Am J Psychiatry. 1994;151:945. Letter. PMID: 8185013
6. Imaz ML, Oriolo G, Torra M et al. Clozapine use during pregnancy and lactation: A case-series report. Front Pharmacol. 2018;9. DOI: doi:10.3389/fphar.2018.00264
7. Dev VJ, Krupp P. Adverse event profile and safety of clozapine. Rev Contemp Pharmacother. 1995;6:197-208.
8. Mendhekar DN. Possible delayed speech acquisition with clozapine therapy during pregnancy and lactation. J Neuropsychiatry Clin Neurosci. 2007;19:196-7. PMID: 17431071
9. Maguire GA. Prolactin elevation with antipsychotic medications: mechanisms of action and clinical consequences. J Clin Psychiatry. 2002;63 (Suppl 4):56-62. PMID: 11913677
10. 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
11. Conca A, Waler M, Walpoth M et al. A case of delayed galactorrhoea as an adverse event of overlapping haloperidol and clozapine administration. Int J Neuropsychopharmacol. 2005;8:303-5. PMID: 15850503
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.
