Is Seroquel (quetiapine) safe to use during pregnancy?

Seroquel (Quetiapine) Use in Pregnancy

Quetiapine can be used during pregnancy when the benefits of treating severe psychiatric illness outweigh the potential risks, as untreated severe mental illness poses significant harm to both mother and fetus. 1, 2

Safety Profile

Malformation Risk

• No consistent pattern of major congenital malformations has been identified with quetiapine exposure during pregnancy. 1, 2
• Limited published data from 63 exposed pregnancies (21 prospective, 42 retrospective) showed no major malformations. 1
• The FDA classifies quetiapine as Pregnancy Category C, indicating animal studies showed embryo-fetal toxicity but no teratogenic effects at clinically relevant doses. 1

Neonatal Complications

• Neonates exposed to quetiapine in the third trimester are at risk for extrapyramidal and/or withdrawal symptoms after delivery. 1
• Reported symptoms include: agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorders. 1
• Severity varies from self-limited symptoms to cases requiring intensive care unit support and prolonged hospitalization. 1
• There is evidence suggesting an association with neonatal respiratory distress and withdrawal symptoms across atypical antipsychotics as a class. 2

Obstetric Risks

• Potential association with gestational diabetes development, though this applies to antipsychotics as a class. 2
• Animal studies showed decreased fetal weights and delays in skeletal ossification at doses 1-2 times the maximum recommended human dose. 1

Clinical Recommendations

When to Use

• Quetiapine should be continued or initiated when severe psychiatric illness (bipolar disorder, schizophrenia, psychosis) requires treatment during pregnancy. 1, 2
• The most commonly used atypical antipsychotics in pregnancy are olanzapine, risperidone, and quetiapine, with quetiapine among the preferred options. 2
• Use the lowest effective dose that maintains maternal psychiatric stability. 1

Critical Caveat

• The harm of untreated severe mental illness during pregnancy—including risk to maternal and fetal wellbeing—typically exceeds the potential medication risks. 2
• Discontinuing treatment risks relapse of severe psychiatric symptoms, which can compromise pregnancy outcomes. 2

Monitoring Requirements

• Arrange for neonatal monitoring immediately after delivery for extrapyramidal symptoms and withdrawal effects. 1
• Screen for gestational diabetes during pregnancy. 2
• Ensure obstetrical follow-up with awareness of potential complications. 1

Breastfeeding Considerations

• Quetiapine is excreted into breast milk, requiring a decision between discontinuing nursing or discontinuing the drug based on maternal need. 1
• Reported breast milk levels range from undetectable to 170 μg/L, with estimated infant doses of 0.09% to 0.43% of the weight-adjusted maternal dose. 1

Key Pitfall to Avoid

Do not discontinue quetiapine in a pregnant woman with severe psychiatric illness without psychiatric consultation, as the risk of maternal decompensation and its consequences for both mother and fetus may far exceed the medication risks. 2