Risks of Aripiprazole Use During Pregnancy
Aripiprazole use during pregnancy carries risks of extrapyramidal and withdrawal symptoms in neonates exposed during the third trimester, though current data do not establish a clear association with major birth defects, miscarriage, or adverse maternal outcomes. 1
Established Risks
Neonatal complications: Neonates exposed to aripiprazole during the third trimester are at risk for:
- Extrapyramidal symptoms (agitation, hypertonia, hypotonia, tremor)
- Withdrawal symptoms (somnolence, respiratory distress, feeding disorders)
- These symptoms vary in severity and may require prolonged hospitalization 1
Pregnancy complications: Limited data suggest potential associations with:
- Pregnancy hypertension
- Lower birth weight
- Shorter gestation at birth
- Higher rates of neonatal admission 2
Animal Studies
Animal reproduction studies have demonstrated concerning findings at doses 10-19 times the maximum recommended human dose, including:
- Fetal death
- Decreased fetal weight
- Undescended testicles
- Delayed skeletal ossification
- Skeletal abnormalities
- Diaphragmatic hernia 1
Risk-Benefit Considerations
- The FDA has established a pregnancy exposure registry for atypical antipsychotics including aripiprazole to monitor pregnancy outcomes 1
- The estimated background risk of major birth defects in the general population is 2-4% 1
- There are significant risks associated with untreated schizophrenia or bipolar disorder during pregnancy, including:
- Increased risk of relapse
- Hospitalization
- Suicide
- Adverse perinatal outcomes 1
Monitoring and Management
- All pregnant women taking aripiprazole should be encouraged to register with the National Pregnancy Registry for Atypical Antipsychotics 1
- Careful monitoring of neonates for extrapyramidal and withdrawal symptoms is essential after delivery
- Symptoms should be managed appropriately, with some neonates recovering within hours or days while others may require prolonged hospitalization 1
Current Evidence Quality
While definitive evidence on aripiprazole's reproductive safety is lacking, newer safety data are relatively reassuring 3. The available data suggest:
- No clear association with major birth defects has been established 1
- Limited data do not suggest an elevated malformation risk 2
- Case reports have documented healthy births following aripiprazole exposure 4, 5
For women with serious mental illness requiring antipsychotic treatment during pregnancy, the potential benefits of aripiprazole may outweigh the potential risks, particularly given its favorable metabolic profile compared to other antipsychotics 3, 2.