Is aripiprazole (Abilify) safe to use during pregnancy?

Aripiprazole Use During Pregnancy

Aripiprazole should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus, as it may cause extrapyramidal and/or withdrawal symptoms in neonates exposed during the third trimester. 1

Safety Profile and Risk Assessment

Fetal Risk

• The FDA drug label indicates that neonates exposed to antipsychotics like aripiprazole during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery 1
• These symptoms may include:
  • Agitation
  • Hypertonia or hypotonia
  • Tremor
  • Somnolence
  • Respiratory distress
  • Feeding disorders

Available Evidence

• Overall available data from published epidemiologic studies have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes 1
• Animal studies showed potential teratogenic effects at doses 10-19 times the maximum recommended human dose, including:
  • Fetal death
  • Decreased fetal weight
  • Skeletal abnormalities
  • Diaphragmatic hernia 1

Pregnancy Registry

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics during pregnancy
• Healthcare providers should register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics (1-866-961-2388) 1

Risk-Benefit Analysis

Maternal Risks of Untreated Illness

• Untreated schizophrenia or bipolar disorder during pregnancy carries significant risks:
  • Increased risk of relapse
  • Hospitalization
  • Suicide
  • Adverse perinatal outcomes including preterm birth 1

Clinical Considerations

1. First-line options: Consider medications with more established safety profiles during pregnancy if appropriate for the patient's condition
2. Monitoring: If aripiprazole is continued during pregnancy, close monitoring of the mother and fetus is essential
3. Third trimester: Be particularly vigilant about potential neonatal complications when exposure occurs during the third trimester
4. Neonatal monitoring: After delivery, monitor the neonate for extrapyramidal and/or withdrawal symptoms 1

Breastfeeding Considerations

• Limited data are available regarding aripiprazole use during breastfeeding
• Some case reports suggest potential lactation failure 2
• A risk-benefit assessment should be made when considering aripiprazole during lactation

Clinical Management Algorithm

1. Assess severity of maternal illness: Determine if medication is essential for maternal stability
2. Consider alternatives: Evaluate if medications with better established safety profiles could be effective
3. If aripiprazole is necessary:
   • Use lowest effective dose
   • Register patient with the National Pregnancy Registry for Atypical Antipsychotics
   • Monitor for pregnancy complications including hypertension 3
   • Plan for neonatal monitoring after delivery
   • Consider potential impact on breastfeeding

Conclusion

While definitive evidence on aripiprazole's reproductive safety is lacking, newer safety data are relatively reassuring 4. The decision to use aripiprazole during pregnancy should carefully weigh the risks of untreated maternal mental illness against the potential risks to the fetus, with close monitoring throughout pregnancy and the postpartum period.