The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-A pregnancy exposure registry is available.
-There are risks to the mother associated with untreated schizophrenia and with exposure to antipsychotics (including this drug) during pregnancy.
-Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms after delivery.

Animal studies have revealed evidence of fetal harm. In 1 study in pregnant rats, no malformations were observed at doses up to 2.4 times the maximum recommended human dose (MRHD), decreased fetal body weight was seen at 4.9 and 14.6 times the MRHD, and incomplete ossification and increased incidences of visceral and skeletal variations were noted in fetuses at 14.6 times the MRHD, a dose that induced maternal toxicity. In another study in pregnant rats, the number of live-born pups was decreased at 2.4 and 4.9 times the MRHD, and an increase in early postnatal deaths, impaired nursing, and decreased pup body weight gain were seen at 4.9 times the MRHD. In a study in pregnant rabbits, no adverse developmental effects were observed at doses up to 9.7 times the MRHD. After pregnant rats were given a human metabolite of this drug (reduced ketone metabolite), no adverse developmental effects were seen at 1.2 times the MRHD, but increases in visceral malformations (cleft palate) and skeletal malformations were seen at 27 and 19 times the MRHD, respectively. Based on findings from animal studies, this drug may impair male and female fertility. There are no controlled data in human pregnancy.

There is risk to the pregnant patient with untreated schizophrenia, including risk of relapse, hospitalization, and suicide compared to treated patients. Schizophrenia is associated with increased adverse perinatal outcomes (including preterm birth); however, it is unknown whether this is a direct result of the illness or other comorbid factors.

Extrapyramidal and/or withdrawal symptoms (including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) have been reported in neonates exposed to antipsychotics during the third trimester of pregnancy; these symptoms have varied in severity. Neonates should be monitored for extrapyramidal and/or withdrawal symptoms and symptoms should be managed appropriately; some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization.

To monitor the outcomes of pregnant women exposed to atypical antipsychotics, the National Pregnancy Registry for Atypical Antipsychotics registry has been established. Physicians are encouraged to register patients by calling 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Aniline metabolites of this drug are associated with toxicity in animal models; however, aniline metabolites were not measured in adult humans at quantifiable levels during clinical trials. It is unknown whether infants will have comparable drug metabolism to adults.

Because this drug is highly bound to plasma proteins, the amount in milk is likely to be low. Until more safety data become available, an alternate agent may be preferred.

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown.
-Animal models have revealed evidence of toxicity.
-Extrapyramidal symptoms (e.g., abnormal muscle movements, tremors), failure to thrive, jitteriness, and sedation have been reported in breastfed infants exposed to antipsychotic agents.

See references