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Are Alpha-2 Adrenergic Agonists Being Used in Infants?
Owais M Aftab1, Hamza Khan1, Albert Bargoud1
1Department of Ophthalmology, Rutgers-New Jersey Medical School, Newark, New Jersey, USA.
Summary
Alpha-2 adrenergic agonists like brimonidine can cause serious adverse events in infants, including hypotonia and central nervous system depression. Enhanced warnings are crucial to prevent accidental infant exposure to these glaucoma medications.
Area of Science:
- Pharmacovigilance
- Pediatric Ophthalmology
- Drug Safety
Background:
- Alpha-2 adrenergic agonists are used to treat glaucoma in infants.
- Systemic absorption and adverse events (AEs) in this population require thorough investigation.
- Brimonidine is a commonly prescribed agent in this class.
Purpose of the Study:
- To identify and quantify adverse events associated with alpha-2 adrenergic agonists, specifically brimonidine, in infants.
- To assess the safety profile of brimonidine in pediatric glaucoma patients.
Main Methods:
- Utilized the Federal Adverse Event Reporting System (FAERS) database from 2004-2023Q1.
- Focused on AE reports for brimonidine in patients aged 12 months or younger.
- Employed disproportionality analysis using data mining algorithms (e.g., PRR, EBGM) to detect significant symptoms.
Main Results:
- Identified 35 unique AE reports for brimonidine in infants.
- Common AEs included hypotonia (20 cases), hypothermia, depressed level of consciousness, lethargy, and pallor.
- Significant systemic AEs were identified, with many cases not involving ophthalmic exposure.
Conclusions:
- Alpha-2 adrenergic agonists, such as brimonidine, are associated with significant systemic adverse events in infants.
- Hypotonia and central nervous system depression are notable risks.
- Enhanced warnings and awareness among ophthalmologists are necessary to prevent unintentional infant exposure.
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