There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. A study analyzing 23 prospectively and 11 retrospectively olanzapine-exposed pregnancies found that the rates for spontaneous abortion, stillbirth, prematurity, and malformation fell within the control range. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to atypical antipsychotics, a National Pregnancy Registry for Atypical Antipsychotics has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/atypicalantipsychotic/.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Comments:
-A pregnancy exposure registry is available.
-Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery.
-Patients should be advised to notify their physician if they are pregnant or plan to become pregnant during treatment.

See references

Use is not recommended.

Excreted into human milk: Yes

Comments:
-The American Academy of Pediatrics classifies antipsychotics (e.g., clozapine) as drugs whose effect on the nursing infant is unknown but may be of concern.
-Exposed infants should be monitored for drowsiness and developmental milestones.

Very limited long-term follow-up of infants exposed to this drug indicate infants generally developed normally. A study involving 7 mother-infant nursing pairs in which the mother received olanzapine at an average daily dose of 7.5 mg (range = 5 to 20 mg) reported a median infant dose ingested from the milk of approximately 1.02% of the maternal dose. Six infants had olanzapine plasma levels below the detectable level. All infants remained healthy and failed to show signs or symptoms of adverse effects. The maximum olanzapine concentration in the milk was shown to be delayed from the corresponding maximum maternal plasma level; therefore, infant exposure may possibly be reduced by avoiding breast-feeding for approximately 5 hours after olanzapine administration. However, the authors recommend all breast-fed infants of mothers receiving olanzapine be monitored closely and the decision to breast-feed only be made if the benefit outweighs the risk.

See references