What are the effects of Quetiapine (Seroquel) on pregnancy?

From the Guidelines

Quetiapine should be used with caution during pregnancy and only when the potential benefits outweigh the risks. The provided evidence does not directly address the use of quetiapine in pregnancy, but it does provide information on the medication's use in other contexts, such as delirium management in adult cancer patients 1. However, based on general medical knowledge, quetiapine is classified as FDA pregnancy category C, meaning animal studies have shown adverse effects but human studies are limited. Some observational studies suggest no significant increase in major birth defects compared to the general population.

• Typical dosing ranges from 150-800mg daily depending on the condition being treated, but the doctor will determine the appropriate dose for the specific situation.
• Babies exposed to antipsychotics late in pregnancy may experience temporary withdrawal symptoms after birth, including agitation, abnormal muscle tone, or feeding difficulties.
• The healthcare provider may recommend additional monitoring during pregnancy and after delivery.
• Regular prenatal care is essential, and the psychiatric and obstetric providers should coordinate care throughout pregnancy.
• It is crucial for pregnant women with serious mental health conditions like bipolar disorder or schizophrenia to consult their healthcare provider before making any medication changes, as untreated psychiatric illness can pose significant risks to both mother and baby.

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. In animal studies, embryo-fetal toxicity occurred 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 There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates.

Quetiapine use in pregnancy is associated with potential risks, including:

• Embryo-fetal toxicity observed in animal studies
• Extrapyramidal and/or withdrawal symptoms in neonates exposed to quetiapine during the third trimester of pregnancy
• Respiratory distress, feeding disorder, and other complications in neonates

The decision to use quetiapine during pregnancy should be made only if the potential benefit justifies the potential risk to the fetus 2.

From the Research

Quetiapine Use in Pregnancy

• Quetiapine is an antipsychotic medication that has been studied in the context of pregnancy, with research indicating its use is associated with increased risks of adverse obstetric and neonatal outcomes 3.
• A study of 36,083 women who gave birth at Kuopio University Hospital, Finland, between 2002 and 2016 found that quetiapine use was associated with higher risk of increased postpartum bleeding in vaginal delivery, prolonged neonatal hospitalization, and higher placental to birth weight ratio 3.
• The use of any antipsychotic, including quetiapine, was associated with a higher risk of gestational diabetes mellitus, increased postpartum bleeding in vaginal delivery, prolonged neonatal hospitalization, and higher placental to birth weight ratio 3.

Pharmacokinetics and Dosing

• Quetiapine has been shown to undergo gestation-related changes in pharmacokinetics, with a decrease in trough plasma concentration during gestation 4.
• A pharmacokinetic modelling study suggested that quetiapine doses in pregnancy should be increased to 500-700 mg twice daily to counteract the changes in metabolic clearance, volume of distribution, and plasma protein binding 4.

Quetiapine in Bipolar Disorder and Anxiety

• Quetiapine has been approved for the treatment of bipolar depression and has been shown to be effective in reducing depressive and anxiety symptoms 5, 6, 7.
• A systematic review of the literature found that quetiapine was effective in controlling anxiety symptoms in patients with mood disorders, including bipolar disorder and major depressive disorder 7.
• However, the use of quetiapine in pregnancy should be carefully considered due to the potential risks of adverse obstetric and neonatal outcomes, and alternative treatments may be preferred in some cases 3.