Can you take Seraquil (Quetiapine) while pregnant?

Quetiapine (Seroquel) Use During Pregnancy

Quetiapine can be used during pregnancy when the benefits of treating severe psychiatric illness outweigh potential risks, as current evidence does not demonstrate a consistent pattern of major congenital malformations or significant adverse outcomes.

FDA Classification and Official Guidance

• The FDA classifies quetiapine as Pregnancy Category C, indicating no adequate well-controlled studies exist in pregnant women, but animal studies showed embryo-fetal toxicity at doses above human therapeutic levels 1
• Quetiapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus 1

Evidence on Congenital Malformations

The reproductive safety data for quetiapine are reassuring:

• In a prospective registry study of 152 women with first-trimester quetiapine exposure, the major malformation rate was 1.3% compared to 1.4% in psychiatric controls without antipsychotic exposure (odds ratio 0.90,95% CI 0.15-5.46) 2
• A more recent analysis of 264 quetiapine-exposed pregnancies found a malformation rate of 1.85% versus 1.77% in controls (odds ratio 1.04,95% CI 0.38-2.85) 3
• Published literature on 63 quetiapine-exposed pregnancies reported no major malformations 1, 4
• No specific patterns of fetal limb or organ malformation related to quetiapine have been identified 5

Neonatal Complications to Monitor

Neonates exposed to antipsychotics including quetiapine during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following 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 between antipsychotic use and increased neonatal respiratory distress and withdrawal symptoms 5

Additional Pregnancy Considerations

• Some evidence suggests an association between antipsychotic use in pregnancy and development of gestational diabetes, requiring monitoring 5
• Animal studies showed delays in skeletal ossification and decreased fetal weights at doses 1-2 times the maximum recommended human dose, but no teratogenic effects 1

Clinical Decision-Making Algorithm

When a pregnant woman requires quetiapine:

1. Assess severity of psychiatric illness - Women with severe mental disorders (schizophrenia, bipolar disorder) typically cannot safely discontinue medication, as untreated illness interferes with activities of daily living and infant care 4

2. Discuss risks versus benefits - The potential harm of untreated severe psychiatric illness during pregnancy often outweighs the relatively low risk of fetal exposure to quetiapine 5

3. If continuing quetiapine:

   • Use the lowest effective dose 1
   • Coordinate care with obstetrics for enhanced monitoring 6
   • Screen for gestational diabetes 5
   • Prepare neonatal team for potential withdrawal symptoms if third-trimester exposure 1

4. Monitor infant after delivery for extrapyramidal symptoms, respiratory distress, feeding difficulties, and signs of withdrawal 1

Breastfeeding Considerations

• Quetiapine is excreted into human milk at levels ranging from undetectable to 170 μg/L 1
• Estimated infant dose ranges from 0.09% to 0.43% of the weight-adjusted maternal dose 1
• A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother's health 1

Key Caveats

The confidence intervals in available studies are wide due to limited sample sizes, meaning rare adverse outcomes cannot be definitively ruled out 2, 3. However, the pooled data from multiple sources consistently show no elevated risk of major malformations compared to psychiatric controls 2, 3.