From the FDA Drug Label
USE IN SPECIFIC POPULATIONS SECTION 8. 1 Pregnancy Pregnancy Category C: Risk Summary There are no adequate and well-controlled studies of quetiapine use in pregnant women. In limited published literature, there were no major malformations associated with quetiapine exposure during pregnancy. Quetiapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antipsychotic drugs (including quetiapine), during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery
Key Points:
- There are no adequate and well-controlled studies of quetiapine use in pregnant women.
- Quetiapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Neonates exposed to quetiapine during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.
Quetiapine use in pregnancy is associated with potential risks, including extrapyramidal and/or withdrawal symptoms in neonates, and should only be used if the potential benefit justifies the potential risk to the fetus 1.
From the Research
Seroquel (quetiapine) should be used during pregnancy only if the benefits outweigh the risks, and this decision should be made with your doctor, considering the most recent evidence from 2023 2. The medication is classified as a Category C medication, meaning animal studies have shown adverse effects on the fetus, but there aren't adequate human studies. If you're currently taking Seroquel and discover you're pregnant, don't stop taking it suddenly as this could cause withdrawal symptoms or a relapse of your condition. Instead, consult your healthcare provider immediately to discuss your specific situation. Some studies suggest a small increased risk of birth defects, particularly in the first trimester, while others show minimal risk, as seen in a study from 2018 3. The medication can cross the placenta and may cause withdrawal symptoms in newborns, including agitation, feeding difficulties, and respiratory distress. If Seroquel is deemed necessary during pregnancy, your doctor will likely prescribe the lowest effective dose, and dose adjustments may be necessary, as suggested by a pharmacokinetic modelling study from 2020 4. Regular monitoring throughout pregnancy is essential, including ultrasounds and fetal assessments. Alternative treatments or therapies might be considered depending on your condition. Key points to consider include:
- Increased risk of gestational diabetes mellitus and postpartum bleeding with antipsychotic use during pregnancy 2
- Potential for prolonged neonatal hospitalization and higher placental to birth weight ratio with quetiapine use 2
- Importance of careful administration and monitoring to minimize potential risks to the developing baby. It's also important to note that animal studies have shown potential neurotoxicological and neurobehavioral effects of quetiapine on fetal development, as seen in a study from 2015 5. However, the decision to use Seroquel during pregnancy should be based on the most recent and highest quality human studies, such as the one from 2023 2, which provides more relevant and applicable evidence for clinical practice.