Systemic Toxicity With Use of Apraclonidine Ophthalmic Drops in Pediatric Patients
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View abstract on PubMed
Summary
This summary is machine-generated.Topical apraclonidine ophthalmic drops can cause serious systemic toxicity in pediatric patients, including CNS and respiratory depression. Healthcare providers should monitor for these risks, especially in infants, when using this medication off-label.
Area Of Science
- Ophthalmology
- Pediatric Pharmacology
- Pharmacovigilance
Background
- Apraclonidine is a topical alpha-2 adrenergic agonist used off-label in pediatric patients to diagnose anisocoria, often to exclude Horner syndrome.
- Systemic toxicity from ophthalmic apraclonidine use in children is not well-characterized.
Purpose Of The Study
- To identify and characterize postmarketing reports of systemic toxicity in pediatric patients who received apraclonidine ophthalmic drops.
- To assess the safety profile of apraclonidine in the pediatric population.
Main Methods
- A comprehensive search of the US Food and Drug Administration's Adverse Event Reporting System and medical literature was conducted.
- Case reports of systemic adverse events in pediatric patients using apraclonidine ophthalmic drops were analyzed.
- Data included demographics, reason for use, dose, latency, interventions, and outcomes.
Main Results
- Twenty-one pediatric patients (median age, 6 months) experienced systemic adverse events.
- The most frequent events were prolonged lethargy and unresponsiveness (81%) and cardiorespiratory compromise (38%), including apnea and hypoxia.
- Infants under one year were most affected, often receiving apraclonidine for diagnostic purposes.
Conclusions
- Pediatric use of apraclonidine ophthalmic drops carries a risk of central nervous system and respiratory depression.
- Clinicians must be vigilant for potential systemic effects and prepared for management in pediatric patients, particularly infants.
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