What is the safety and efficacy of Quetiapine (Seroquel) in pregnancy?

Safety of Quetiapine (Seroquel) in Pregnancy

Quetiapine use during pregnancy should be approached with caution as there is limited evidence regarding its safety, though current data does not suggest it is a major teratogen.

Evidence on Quetiapine in Pregnancy

Malformation Risk

• The National Pregnancy Registry for Psychiatric Medications reports an absolute risk of major malformations of 1.85% for quetiapine-exposed pregnancies compared to 1.77% in controls (odds ratio 1.04,95% CI = 0.38-2.85) 1
• No specific patterns of malformations have been observed in infants exposed to quetiapine during pregnancy 1

Metabolic Concerns

• Quetiapine is classified among the "high-risk metabolic second-generation antipsychotics" with increased risks for:
  • Gestational diabetes (adjusted risk ratio 1.8,95% CI 1.3-2.4) compared to untreated pregnant women 2
  • Infants being large for gestational age (adjusted risk ratio 1.6,95% CI 1.3-1.9) 2

Neonatal Risks

• According to the FDA drug label, quetiapine may cause extrapyramidal and/or withdrawal symptoms in neonates including:
  • Agitation
  • Hypertonia or hypotonia
  • Tremor
  • Somnolence
  • Respiratory distress
  • Feeding disorders 3

Clinical Approach to Quetiapine Use in Pregnancy

Preconception Planning

1. For women planning pregnancy who are on quetiapine:
   • Evaluate the necessity of continued treatment
   • Consider risks of untreated psychiatric illness versus medication risks
   • Discuss pregnancy registry enrollment

Monitoring During Pregnancy

1. Enhanced metabolic monitoring is essential:

   • Regular screening for gestational diabetes
   • Careful monitoring of maternal weight gain
   • Fetal growth assessment

2. Prepare for potential neonatal complications:

   • Alert pediatric team about maternal quetiapine use
   • Monitor neonate for extrapyramidal symptoms and withdrawal

Important Considerations

Risks of Discontinuation

• Untreated psychiatric illness during pregnancy carries significant risks for both mother and child
• Abrupt discontinuation of antipsychotics can lead to relapse of psychiatric symptoms

Documentation and Informed Consent

• Thoroughly document risk-benefit discussions
• Consider pregnancy registry enrollment to improve data collection on quetiapine safety

Pitfalls to Avoid

1. Overestimating teratogenic risk: Current evidence does not suggest quetiapine is a major teratogen, but metabolic risks are significant 2, 1

2. Inadequate metabolic monitoring: Women on quetiapine during pregnancy require enhanced screening for gestational diabetes and careful monitoring of fetal growth 2

3. Failure to prepare for neonatal effects: Healthcare providers should anticipate and be prepared to manage potential neonatal withdrawal or extrapyramidal symptoms 3

While the data on quetiapine use in pregnancy remains limited, the current evidence suggests it may be used when benefits outweigh risks, with appropriate monitoring for metabolic complications and preparation for potential neonatal effects.