Can Breztri (budesonide, glycopyrrolate, formoterol) cause hallucinations?

Can Breztri Cause Hallucinations?

Breztri (budesonide/glycopyrrolate/formoterol) is not typically associated with hallucinations as a common side effect, though glycopyrrolate (the anticholinergic component) has the potential to cause hallucinations in rare cases, particularly in elderly patients or those with predisposing factors.

Mechanism and Risk Assessment

Breztri Aerosphere is a triple combination inhaler containing:

• Budesonide (inhaled corticosteroid)
• Glycopyrrolate (long-acting muscarinic antagonist/LAMA)
• Formoterol (long-acting β2-agonist/LABA)

Component-Specific Risks:

1. Glycopyrrolate (anticholinergic):

   • Anticholinergic medications can cross the blood-brain barrier and potentially cause neuropsychiatric effects
   • According to clinical guidelines, anticholinergic drugs may cause hallucinations in susceptible individuals 1
   • Glycopyrrolate specifically has less blood-brain barrier penetration than other anticholinergics like scopolamine 1

2. Budesonide and Formoterol:

   • Neither the corticosteroid nor the LABA components are commonly associated with hallucinations

Evidence from Clinical Studies

The clinical trials and pharmacokinetic studies of Breztri do not specifically highlight hallucinations as a common adverse effect:

• In a 52-week safety study of Breztri in Japanese patients, no hallucinations were reported among the common adverse events 2
• Pharmacokinetic studies of Breztri did not report hallucinations as a notable adverse effect 3, 4

Risk Factors for Anticholinergic-Induced Hallucinations

Patients at higher risk for experiencing hallucinations with anticholinergic medications like glycopyrrolate include:

• Elderly patients
• Patients with cognitive impairment or dementia
• Those with hepatic or renal impairment (affecting drug clearance)
• Patients taking multiple medications with anticholinergic properties
• Individuals with a history of psychiatric disorders

Clinical Guidance

If a patient reports hallucinations while using Breztri:

1. Evaluate for other causes:

   • Rule out delirium from other medications or medical conditions
   • Consider drug interactions that might increase anticholinergic burden

2. Management options:

   • Consider temporary discontinuation to determine if Breztri is the cause
   • Evaluate for alternative COPD treatments with lower anticholinergic burden
   • For patients who require triple therapy but experience anticholinergic side effects, consider separate inhalers with dose adjustment of the anticholinergic component

Conclusion

While hallucinations are not listed among the common side effects of Breztri, the anticholinergic component (glycopyrrolate) has the potential to cause such effects, particularly in vulnerable populations. Clinicians should monitor patients, especially those with risk factors, and consider alternative treatments if hallucinations occur.