Apraclonidine Eye Drops Can Cause Serious Systemic Adverse Effects in Children

Objective: To describe systemic adverse effects of topical apraclonidine eye drop use in pediatric patients. Design: Clinical case series. Methods: The authors performed a search of records in the FDA Adverse Event Reporting System and of PubMed and Embase databases of the published medical literature to identify reports of adverse events of the use of apraclonidine 0.25%, 0.5%, or 1.0% eye drops in pediatric patients. Only reports of systemic adverse events were evaluated. Cases were reviewed, and the types of adverse events were described based on these reports. Results: 21 adverse event reports described systemic symptoms after administration of topical apraclonidine to pediatric patients. Patients ranged in age from 12 days to 6 years. Punctal occlusion was not mentioned as a technique used to reduce systemic absorption in any case. The most frequently reported adverse effect was lethargy and unresponsiveness, occurring in 81% of reported events. The next most common category of more...