Quetiapine Use in Pregnancy
Yes, quetiapine is prescribed during pregnancy when the potential benefit justifies the potential risk to the fetus, particularly for women with severe psychiatric illnesses who cannot safely discontinue treatment. 1
FDA Classification and Safety Profile
- Quetiapine is FDA Pregnancy Category C, meaning there are no adequate and well-controlled studies in pregnant women 1
- Limited published data show no major malformations associated with quetiapine exposure during pregnancy 1, 2
- Among 63 documented pregnancies with quetiapine exposure, no major malformations were reported 1
- A prospective registry study found major malformations in 1.3% of quetiapine-exposed infants versus 1.4% in psychiatric controls (odds ratio 0.90,95% CI 0.15-5.46), indicating no increased risk 3
Clinical Indications for Use
Quetiapine is commonly prescribed during pregnancy for:
- Bipolar disorder, particularly manic episodes 4
- Schizophrenia and other psychotic disorders 2, 5
- Various psychiatric conditions requiring antipsychotic treatment 2
The peak age of onset for these conditions (25-35 years) coincides with peak childbearing years, making pregnancy exposure common 5
Known Risks and Monitoring Requirements
Neonatal Complications
- Third-trimester exposure carries risk for extrapyramidal and/or withdrawal symptoms in neonates 1
- Reported neonatal symptoms include: agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorders 1
- Severity varies from self-limited symptoms to requiring intensive care unit support and prolonged hospitalization 1
Maternal Risks
- Some evidence suggests association with gestational diabetes 2
- Increased risk of neonatal respiratory distress 2
Animal Data
- No teratogenic effects at doses up to 2.4 times the maximum recommended human dose 1
- Evidence of embryo-fetal toxicity including delayed skeletal ossification and decreased fetal weights at higher doses 1
Clinical Approach
The decision to continue quetiapine should weigh the severe consequences of untreated psychiatric illness against potential fetal risks:
- Untreated severe mental illness during pregnancy poses significant risks to both mother and fetus 2, 5
- Women with psychotic illnesses have higher rates of unplanned pregnancies and may be unable to care for an infant if untreated 5
- Careful administration of antipsychotics is recommended for pregnant women with severe mental disorders 2
Dosing Considerations
- Therapeutic doses up to 1200 mg/day have been used successfully during pregnancy with normal infant outcomes 4
- Close obstetrical and perinatal monitoring by a consultant obstetrician is essential 4
Breastfeeding Considerations
- Quetiapine is excreted into human milk 1
- A decision should be made to discontinue nursing or discontinue the drug, considering the importance of the drug to the mother's health 1
- Potential for serious adverse reactions in nursing infants exists 1
Common Pitfalls to Avoid
- Do not abruptly discontinue quetiapine upon pregnancy discovery without psychiatric consultation, as this may precipitate severe psychiatric decompensation 2, 5
- Do not assume all antipsychotics carry equal risk—quetiapine, olanzapine, and risperidone are the most commonly used with relatively reassuring safety data 2
- Ensure neonatal monitoring is arranged for third-trimester exposures to detect and manage potential withdrawal or extrapyramidal symptoms 1