Can Vraylar (cariprazine) cause suicidal thoughts?

Vraylar (Cariprazine) and Suicidal Thoughts

Yes, Vraylar (cariprazine) can cause suicidal thoughts, particularly in young adults under 24 years of age, as indicated by its FDA boxed warning. 1

FDA Boxed Warning and Risk Profile

Vraylar carries a black box warning regarding suicidal thoughts and behaviors, specifically noting:

• Antidepressants, including Vraylar when used as adjunctive therapy for major depressive disorder, increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients 1
• Healthcare providers must closely monitor all patients treated with Vraylar for clinical worsening and emergence of suicidal thoughts and behaviors 1

Risk Assessment and Monitoring

When prescribing Vraylar, the following monitoring protocol should be implemented:

• Initial period: Most critical time for monitoring is during the first few weeks of treatment and following dosage changes 1
• High-risk patients: Those with pre-existing psychiatric conditions, history of suicidal ideation, or substance use disorders may be at increased risk 2
• Monitoring frequency: Regular assessment of mood changes, new or worsening depression, anxiety, agitation, or emergence of suicidal thoughts 1

Warning Signs to Monitor

Pay particular attention to these specific warning signs:

• Thoughts about suicide or dying
• Attempts to commit suicide
• New or worsening depression or anxiety
• Feeling very agitated or restless
• Panic attacks
• Insomnia
• New or worsening irritability
• Aggressive behavior, anger, or violence
• Acting on dangerous impulses
• Extreme increases in activity and talking (mania)
• Other unusual changes in behavior or mood 1

Risk Management Strategies

To mitigate the risk of suicidal ideation:

1. Patient education: Inform patients and caregivers about the risk of suicidal thoughts and behaviors and instruct them to report concerning symptoms immediately 1

2. Dosing considerations:

   • Start with the recommended initial dose of 1.5 mg daily
   • Titrate slowly to the effective dose (1.5-6 mg for schizophrenia; 1.5-3 mg for bipolar depression or MDD) 1
   • Avoid rapid dose escalation which may increase side effect risk

3. Regular follow-up: Schedule frequent visits during the initial treatment period and after dose adjustments 1

4. Safety planning: Develop a safety plan with patients who may be at risk, including emergency contacts and steps to take if suicidal thoughts emerge

Special Populations at Higher Risk

Certain patients may require additional monitoring:

• Young adults (under 24 years)
• Patients with a history of psychiatric disorders
• Those with previous suicide attempts
• Patients with comorbid substance use disorders 2

Clinical Context

While the risk of suicidal thoughts exists with Vraylar, this must be balanced against its therapeutic benefits:

• The medication is effective for schizophrenia, bipolar disorder (manic/mixed episodes and depression), and as adjunctive therapy for major depressive disorder 1
• The absolute risk of suicidal ideation with antipsychotics/antidepressants is relatively low but requires vigilant monitoring 3

Common Pitfalls to Avoid

• Failure to monitor: Not scheduling regular follow-up appointments during the critical initial treatment period
• Ignoring warning signs: Dismissing early symptoms of behavioral activation or mood changes
• Inadequate patient education: Not informing patients and families about potential risks and warning signs
• Rapid titration: Increasing doses too quickly, which may increase side effect burden

Remember that the emergence of suicidal thoughts requires immediate clinical attention and may necessitate medication adjustment, additional interventions, or in severe cases, hospitalization.