Aripiprazole (Abilify) Use in Pregnancy
Aripiprazole can be used during pregnancy when the benefits of treating the underlying psychiatric condition outweigh potential risks, as available data do not establish a clear drug-associated risk of major birth defects or adverse maternal-fetal outcomes, though neonates require monitoring for extrapyramidal and withdrawal symptoms. 1
Key Safety Considerations
Reproductive Safety Profile
No established increased risk of major birth defects: Published epidemiologic studies and observational data from pregnant women exposed to aripiprazole have not demonstrated a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes 1
Retrospective database evidence: A Medicaid database study of 9,258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects 1
Systematic review findings: A 2018 comprehensive systematic review concluded that while definitive evidence on aripiprazole reproductive safety is lacking, newer safety data are relatively reassuring, and in many cases the potential benefits for patients with bipolar disorder or schizophrenia outweigh the potential risks 2
Critical Neonatal Monitoring Requirements
Neonates exposed to aripiprazole during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery 1:
Symptoms include agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder 1
Symptom severity varies considerably—some neonates recover within hours or days without specific treatment, while others require prolonged hospitalization 1
Monitor all exposed neonates and manage symptoms appropriately 1
Risk-Benefit Framework
Maternal Risks of Untreated Illness
Untreated schizophrenia carries significant maternal risks including increased risk of relapse, hospitalization, and suicide 1
Schizophrenia itself is associated with increased adverse perinatal outcomes, including preterm birth, though it remains unclear whether this results directly from the illness or comorbid factors 1
A prospective longitudinal study of 201 pregnant women with major depressive disorder found that women who discontinued antidepressants during pregnancy were more likely to experience relapse compared to those who continued treatment 1
Animal Data Context
Animal studies showed developmental toxicity at doses 10 times the maximum recommended human dose, including fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia 1
These findings occurred at supratherapeutic doses and have limited direct applicability to human pregnancy outcomes 3
Clinical Management Algorithm
Preconception Planning
Discuss treatment options with women of childbearing potential before conception, weighing risks of medication exposure against risks of untreated psychiatric illness 1
Encourage pregnancy registry enrollment: Healthcare providers should register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 1
During Pregnancy
Continue aripiprazole if clinically indicated, particularly when discontinuation would pose significant risk of psychiatric decompensation 2
Use the lowest effective dose to maintain psychiatric stability 4
Avoid abrupt discontinuation, as this increases risk of relapse 1
Peripartum Period
Alert neonatal team to third-trimester aripiprazole exposure to ensure appropriate monitoring 1
Prepare for potential need for prolonged neonatal observation or intervention 1
Common Pitfalls to Avoid
Failing to weigh maternal psychiatric risks: The risks of untreated schizophrenia or bipolar disorder often exceed theoretical medication risks, particularly given the relatively reassuring human data for aripiprazole 1, 2
Abrupt medication discontinuation: Sudden cessation increases risk of psychiatric relapse, which itself poses risks to both mother and fetus 1
Inadequate neonatal monitoring: All third-trimester exposures require neonatal surveillance for extrapyramidal and withdrawal symptoms 1
Not enrolling in pregnancy registries: Registry participation is essential for expanding the evidence base on reproductive safety 1