Vraylar (Cariprazine) Use During Pregnancy
Direct Answer
Vraylar should generally be avoided during pregnancy, particularly in the third trimester, due to risk of neonatal extrapyramidal symptoms and withdrawal, though it may be continued if the benefits of preventing maternal psychiatric relapse outweigh the fetal risks. 1
FDA Labeling and Warnings
The FDA-approved prescribing information for Vraylar explicitly warns that:
- Third trimester use may cause abnormal muscle movements (extrapyramidal symptoms) or withdrawal symptoms in the newborn 1
- Patients should notify their healthcare provider if they become pregnant or suspect pregnancy during treatment 1
- A pregnancy exposure registry exists for monitoring outcomes (National Pregnancy Registry for Atypical Antipsychotics: 1-866-961-2388) 1
Clinical Decision-Making Algorithm
Step 1: Assess Maternal Psychiatric Stability
- If the patient is psychiatrically stable and can tolerate medication discontinuation: Consider switching to an antipsychotic with more pregnancy safety data before conception or in early pregnancy 2
- If the patient has severe schizophrenia or bipolar disorder with high relapse risk: Continuing Vraylar may be justified, as untreated maternal psychiatric illness poses significant risks to both mother and fetus 3
Step 2: Timing Considerations
- First trimester: Avoid initiating Vraylar if possible, as this is the period of organogenesis when teratogenic risks are highest 2, 4
- Second trimester: Limited data exist, but one case report showed safe continuation without adverse effects 3
- Third trimester: Highest concern for neonatal complications (extrapyramidal symptoms, withdrawal); if continued, prepare neonatal team for potential complications 1
Step 3: Consider Alternative Antipsychotics
- Antipsychotics with longer safety records in pregnancy (e.g., haloperidol, chlorpromazine) should be considered as alternatives, though they carry their own risks 2
- The decision to switch must weigh the risk of maternal relapse during medication transition against potential fetal benefits 3
Available Safety Data
Limited Human Evidence
- Only one published case report exists documenting successful Vraylar continuation throughout pregnancy without adverse maternal or neonatal outcomes 3
- This single case is insufficient to establish safety, but demonstrates that continuation may be feasible in selected patients 3
Pharmacological Concerns
- Cariprazine has a very long half-life (weeks), meaning late-occurring adverse effects may appear well after initiation and the drug persists long after discontinuation 1
- This prolonged presence increases theoretical risk of sustained fetal exposure 1
Common Pitfalls to Avoid
Do not abruptly discontinue Vraylar without psychiatric consultation, as this may precipitate severe maternal relapse that poses greater risk than continued use 3
Do not assume all atypical antipsychotics have equivalent pregnancy risk—each has distinct safety profiles, and Vraylar specifically lacks adequate human data 1, 4
Do not fail to counsel about the pregnancy registry—enrollment provides valuable safety data and may benefit future patients 1
Do not forget to alert the neonatal team if Vraylar is continued into the third trimester, as newborns require monitoring for extrapyramidal symptoms and withdrawal 1
Monitoring Requirements if Continued
- Close psychiatric monitoring for maternal symptom control 3
- Serial fetal ultrasounds to assess growth and development 4
- Neonatal observation for at least 48-72 hours after delivery for signs of extrapyramidal symptoms (muscle rigidity, tremor, abnormal movements) or withdrawal (irritability, feeding difficulties, respiratory distress) 1
Risk-Benefit Discussion Points
Risks of continuing Vraylar:
- Neonatal extrapyramidal symptoms and withdrawal (documented FDA warning) 1
- Unknown teratogenic potential due to limited human data 3
- Prolonged fetal exposure due to long half-life 1
Risks of discontinuing Vraylar: