Can I take olanzapine while pregnant or breastfeeding?

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including olanzapine, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs, including olanzapine, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations). Overall available data from published epidemiologic studies of pregnant women exposed to olanzapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). There are risks to the mother associated with untreated schizophrenia or bipolar I disorder and with exposure to antipsychotics, including olanzapine, during pregnancy (see Clinical Considerations) .

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Olanzapine (oral), REMEDYREPACK INC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

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, irritability, poor feeding, tremors and abnormal muscle movements have occurred. Limited long-term follow-up of infants exposed to olanzapine indicates that infants generally developed normally. A safety scoring system finds olanzapine to be acceptable during breastfeeding.[1] Systematic reviews of second-generation antipsychotics concluded that olanzapine seems to be a first-line agent during breastfeeding.[2-4] Monitor the infant for drowsiness, irritability, poor feeding, tremors and abnormal muscle movements in the short-term, and developmental milestones over time, especially if other antipsychotics are used concurrently.

No information is available on the use of samidorphan, which is a component of Lybalvi, during breastfeeding. If a mother requires olanzapine and samidorphan it is not a reason to discontinue breastfeeding. Because samidorphan is a partial opiate agonist, the combination might cause increased drowsiness or respiratory depression than olanzapine alone.

“Summary of Use during Lactation”, LactMed record “Olanzapine” (LM205), quoted verbatim. Everything LactMed reports about Olanzapine while breastfeeding.

8.2 Lactation Risk Summary Olanzapine is present in human milk. There are reports of excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to olanzapine through breast milk (see Clinical Considerations). There is no information on the effects of olanzapine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for olanzapine and any potential adverse effects on the breastfed child from olanzapine or from the mother’s underlying condition.

Prescribing label, section “8.2 Lactation” (opening excerpt): Olanzapine (oral), REMEDYREPACK INC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.