Systemic Toxicity With Use of Apraclonidine Ophthalmic Drops in Pediatric Patients

Does the use of apraclonidine ophthalmic drops in pediatric patients pose a risk for serious systemic toxicity?This is a case series of 21 pediatric patients who developed prolonged lethargy and unresponsiveness, apnea, hypoxia, bradycardia, blood pressure changes, and respiratory failure following the administration of apraclonidine ophthalmic drops. Most patients were infants administered apraclonidine for diagnostic purposes.Clinicians who use apraclonidine in the pediatric population should be aware of potential serious systemic effects from ophthalmic use of the drug and be prepared to manage these.

Corresponding Author: Paula Gish, Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993 (paula.gish@fda.hhs.gov).

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