Seroquel XR (Quetiapine) in Pregnancy
Primary Recommendation
Quetiapine can be used during pregnancy when the potential benefit justifies the potential risk to the fetus, but it is classified as FDA Pregnancy Category C with limited human safety data and evidence of embryo-fetal toxicity in animal studies. 1
Risk Assessment
Human Data - Limited but Reassuring
- Published literature on quetiapine exposure during pregnancy shows no major malformations in limited case series: 21 women in a prospective study and 42 additional cases (36 from one study, 6 case reports) all delivered infants without major congenital anomalies 1
- However, the small number of exposed pregnancies means these data cannot reliably estimate the true frequency or absence of adverse outcomes 1
Neonatal Adaptation Syndrome - Key Concern
- Neonates exposed to antipsychotic drugs 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 considerably: some cases are self-limited while others require intensive care unit support and prolonged hospitalization 1
Animal Data - Evidence of Toxicity
- No teratogenic effects at doses up to 2.4 times the maximum recommended human dose (MRHD) of 800 mg/day 1
- Embryo-fetal toxicity observed: delays in skeletal ossification at approximately 1-2 times MRHD in both rats and rabbits, increased carpal/tarsal flexure in rabbits, and decreased fetal weights 1
- Preliminary peri/postnatal studies showed increases in fetal and pup death at 3 times MRHD 1
Clinical Decision Framework
When to Continue Quetiapine
- Severe psychiatric illness requiring treatment where discontinuation poses significant risk to maternal health 1
- Psychotic disorders, bipolar disorder, or severe depression unresponsive to safer alternatives 2
- The risk of untreated maternal psychiatric illness (which can include poor prenatal care, substance abuse, suicide risk) must be weighed against potential fetal risks 1, 2
Use the Lowest Effective Dose
- Minimize fetal exposure by using the minimum dose necessary to maintain maternal psychiatric stability 2
- This principle applies across all medications used in pregnancy where treatment is deemed necessary 2
Timing Considerations
- First trimester: Organ differentiation occurs during early pregnancy weeks, making medication review critical when planning pregnancy 2
- Third trimester: Highest risk period for neonatal adaptation syndrome; anticipate need for neonatal monitoring 1
Monitoring and Management
Prenatal Planning
- Review medication necessity when pregnancy is being planned, not just after conception occurs 2
- Discuss risks and benefits thoroughly with the patient, documenting shared decision-making 1
Neonatal Monitoring
- Arrange for early follow-up after hospital discharge for infants exposed to quetiapine 3
- Monitor newborns for signs of withdrawal/adaptation syndrome: respiratory distress, feeding difficulties, tremor, abnormal muscle tone, irritability 1
- Be prepared for potential need for intensive care support in severely affected infants 1
Breastfeeding Considerations
Quetiapine is excreted into human milk; discontinue nursing or discontinue the drug based on the importance of the medication to maternal health 1
Common Pitfalls to Avoid
- Do not abruptly discontinue quetiapine without psychiatric consultation, as relapse of severe mental illness poses significant maternal and fetal risks 2
- Do not assume all antipsychotics carry identical risks; quetiapine has its own specific risk profile that differs from other agents 1
- Do not fail to prepare the neonatal team for potential adaptation syndrome when third-trimester exposure has occurred 1
- Do not rely solely on animal data to make clinical decisions; the limited human data, while reassuring for major malformations, is more clinically relevant 1