Is Kventiax (quetiapine) safe to use during pregnancy?

Quetiapine (Kventiax) Use During Pregnancy

Quetiapine can be used during pregnancy when clinically necessary, as available evidence does not demonstrate an increased risk of major congenital malformations, though neonatal monitoring for withdrawal and extrapyramidal symptoms is essential in the third trimester.

Safety Profile for Major Malformations

• No increased risk of major malformations has been demonstrated in the largest prospective registry study, which found a malformation rate of 1.3% (2/155 infants) with first-trimester quetiapine exposure compared to 1.4% (3/210 infants) in psychiatric controls without antipsychotic exposure (OR 0.90,95% CI 0.15-5.46) 1

• The FDA label confirms that in limited published literature with 63 exposed pregnancies (21 from one observational study, 42 from other reports), no major malformations were associated with quetiapine exposure 2

• Multiple case reports and small series consistently show normal infant outcomes with no specific pattern of organ or limb malformations 3, 4, 5, 6

Critical Neonatal Risks Requiring Monitoring

Third-trimester exposure carries significant risk for neonatal complications that require immediate postnatal surveillance 2:

• Neonates exposed to quetiapine in the third trimester are at risk for extrapyramidal symptoms and/or withdrawal symptoms including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorders 2

• These complications vary in severity from self-limited symptoms to cases requiring intensive care unit support and prolonged hospitalization 2

• All infants should be monitored carefully after delivery for these symptoms, particularly in the first 48-72 hours 2

Risk-Benefit Framework

The decision to continue quetiapine should weigh maternal psychiatric stability against fetal/neonatal risks 2:

• Quetiapine should be used during pregnancy "only if the potential benefit justifies the potential risk to the fetus" per FDA guidance 2

• Women with severe psychiatric illnesses (schizophrenia, bipolar disorder) typically cannot safely discontinue antipsychotic therapy, as untreated illness interferes with activities of daily living and infant care 3

• The peak age of onset for schizophrenia in women (25-35 years) coincides with peak childbearing years, and women with psychotic illnesses have higher rates of unplanned pregnancies 3

Practical Management Algorithm

For women requiring quetiapine during pregnancy 2, 5:

1. Continue therapy if clinically indicated - the risk of untreated severe mental illness typically outweighs the modest fetal risks 3, 5

2. Arrange enhanced obstetrical monitoring throughout pregnancy, with particular attention to gestational diabetes screening (some evidence suggests association between antipsychotics and gestational diabetes) 5

3. Plan for neonatal observation - coordinate with pediatrics/neonatology for immediate postnatal monitoring of withdrawal symptoms, respiratory distress, feeding difficulties, and extrapyramidal signs 2

4. Document informed consent - discuss the available safety data showing no increased malformation risk but acknowledge the limited data and neonatal complication risks 2, 1

Breastfeeding Considerations

• Quetiapine is excreted into breast milk at levels ranging from undetectable to 170 μg/L, with estimated infant doses of 0.09-0.43% of the weight-adjusted maternal dose 2

• The FDA recommends deciding whether to discontinue nursing or the drug based on the importance of the medication to maternal health 2

• Calculated infant daily doses range from <0.01 mg/kg (maternal dose up to 100 mg daily) to 0.1 mg/kg (maternal dose 400 mg daily) based on limited data from 8 mother-infant pairs 2

Common Pitfalls to Avoid

• Do not discontinue quetiapine abruptly due to pregnancy discovery - the risk of maternal psychiatric decompensation and relapse typically exceeds fetal risks 3, 5

• Do not assume all antipsychotics carry equal risk - quetiapine, olanzapine, and risperidone are the most studied in pregnancy and appear safest based on available data 5

• Do not fail to arrange neonatal monitoring - third-trimester exposure mandates postnatal observation even if the pregnancy was otherwise uncomplicated 2