What are the risks and recommendations for using Vraylar (cariprazine) in pregnant women or those planning to become pregnant?

Vraylar (Cariprazine) in Pregnancy

Vraylar should generally be avoided during pregnancy unless the severity of maternal psychiatric illness clearly justifies the potential risks to the fetus, as third-trimester exposure may cause abnormal muscle movements or withdrawal symptoms in the newborn. 1

FDA Labeling and Pregnancy Warnings

The FDA label for Vraylar explicitly warns that taking cariprazine during the third trimester of pregnancy may cause extrapyramidal symptoms and/or withdrawal symptoms in neonates after birth. 1 Patients should notify their healthcare provider immediately if they become pregnant or suspect pregnancy during treatment. 1

Risk Assessment Framework

Known Risks to the Fetus

• Third-trimester exposure carries the highest concern for neonatal complications, specifically:
  • Abnormal muscle movements (extrapyramidal symptoms) in the newborn 1
  • Withdrawal symptoms after birth 1

Limited Safety Data

• Reproductive safety data for cariprazine are extremely limited, as it is a recently approved antipsychotic. 2
• Only a single case report exists documenting cariprazine maintenance throughout pregnancy, which showed no adverse effects on pregnancy course or newborn health, though this represents insufficient evidence for broad safety conclusions. 2

Clinical Decision-Making Algorithm

For Women Planning Pregnancy

1. Reassess the necessity of antipsychotic treatment and consider whether the psychiatric condition can be managed with better-studied alternatives. 3
2. If antipsychotic therapy is essential, switch to an agent with more established pregnancy safety data before conception. 4
3. Ensure effective contraception while taking Vraylar if pregnancy is not desired. 1

For Unplanned Pregnancy on Vraylar

1. Do not abruptly discontinue without psychiatric consultation, as untreated severe mental illness poses significant maternal and fetal risks. 3
2. Conduct shared decision-making weighing:
   • Severity of the underlying psychiatric condition 2
   • Risk of relapse if medication is discontinued 2
   • Limited but concerning fetal risks, particularly in the third trimester 1
3. Consider switching to an antipsychotic with more pregnancy data if clinically feasible without destabilizing the patient. 4

Monitoring During Pregnancy

• Enroll in the National Pregnancy Registry for Atypical Antipsychotics by calling 1-866-961-2388 to contribute to safety knowledge. 1
• Plan for neonatal monitoring if third-trimester exposure occurs, as newborns may require observation for extrapyramidal symptoms and withdrawal. 1

Important Caveats

General Principles of Drug Use in Pregnancy

• Only approximately 20 drugs or drug groups are definitively known to cause birth defects in humans, and for most known teratogens, over 90% of first-trimester exposures result in normal offspring. 3
• Drug exposure must occur at a critical developmental stage, at sufficient dose, and for adequate duration to cause teratogenic effects. 3
• Concerns differ markedly between trimesters: first-trimester risks involve structural malformations, while second and third-trimester risks involve pharmacological effects on maturing fetal organ systems. 3

The Untreated Illness Risk

• Untreated severe psychiatric illness during pregnancy carries substantial risks including poor prenatal care, substance use, suicide, and adverse pregnancy outcomes. 3
• The case report demonstrating successful cariprazine maintenance suggests that continuing treatment may be protective against relapse in carefully selected cases. 2

Breastfeeding Considerations

• It is unknown whether cariprazine passes into breast milk. 1
• Patients should discuss feeding options with their healthcare provider before delivery. 1

Key Clinical Pitfall to Avoid

Do not allow fear of medication exposure to result in undertreating severe psychiatric illness during pregnancy. The risk-benefit calculation must account for both medication risks and the substantial dangers of uncontrolled maternal psychiatric disease. 3, 4 However, given the limited safety data for cariprazine specifically and the availability of antipsychotics with more established pregnancy profiles, Vraylar should not be considered a first-line option for pregnant women or those planning conception.