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Ocular and systemic side effects of brimonidine 0.2% eye drops (Alphagan) in children
R J C Bowman1, J Cope, K K Nischal
1Department of Ophthalmology, Great Ormond Street Hospital for Children, Great Ormond Street, London, UK.
Insights
Brimonidine 0.2% eye drops caused adverse effects in 27% of pediatric patients, leading six children to stop treatment due to side effects like tiredness and fainting. Further research is needed to understand the full safety profile in children.
Area of Science:
- Ophthalmology
- Pediatric Pharmacology
- Clinical Safety
Background:
- Brimonidine 0.2% (Alphagan) is a topical alpha-2 agonist used for hypertension.
- Systemic adverse effects, including CNS depression, have been reported in children using brimonidine 0.2%.
- Limited safety data exists for brimonidine 0.2% in pediatric populations.
Purpose of the Study:
- To evaluate the safety and adverse effects of brimonidine 0.2% in pediatric patients.
- To determine the incidence of systemic adverse effects requiring discontinuation of brimonidine 0.2% in children.
Main Methods:
- Retrospective review of computerized pharmacy records and patient notes.
- Identification of pediatric patients prescribed brimonidine 0.2% between August 1999 and June 2001.
- Analysis of treatment duration, concomitant medications, and reasons for discontinuation.
Main Results:
- Twenty-two pediatric patients were analyzed, with a mean age of 8 years.
- Brimonidine 0.2% was used for a mean of 14 months, often in conjunction with other topical hypotensive agents.
- Six out of 22 patients (27%) discontinued brimonidine 0.2% due to adverse effects, including local irritation, tiredness, and fainting.
Conclusions:
- Brimonidine 0.2% use in children resulted in systemic adverse effects necessitating drug cessation in 27% of cases.
- Potential for unnoticed adverse effects, such as educational impairment, exists in pediatric patients.
- Larger studies are required to fully investigate the safety of brimonidine 0.2% in children.
Introduction:
Brimonidine 0.2% (Alphagan) is a topical alpha-2 agonist widely used as an antihypertensive. There have been occasional reports of systemic adverse effects in children including apparent central nervous system depression. There are few data available on the overall safety of brimonidine 0.2% in children.
Methods:
Computerised pharmacy records were used to identify all children who had been prescribed brimonidine 0.2% in our eye department between August 1999 and June 2001, and their notes were reviewed.
Results:
In all, 23 patients were identified from pharmacy records and 22 sets of notes were recovered and reviewed. The mean age at commencement of treatment was 8 years (range 0-14 years). In all, 10 (46%) were treated in one eye and 12 (54%) in both. Brimonidine 0.2% was taken for a mean 14 months (range 1 day-75 months). A total of 14 (64%) patients were already taking a topical beta-blocker when brimonidine 0.2% was commenced and a further four (18%) were being treated with another topical hypotensive agent. Of the 22 patients, six (27%) had to stop brimonidine 0.2% because of adverse side effects (two because of local irritation/allergy, two because of tiredness, and two because of fainting attacks).
Discussion:
Many topical hypotensive agents are not licensed for use in children and few safety data are available. In this study, 18% of children had systemic adverse effects sufficient to necessitate stopping the drug. It is possible that educational impairment may have passed unnoticed in others. Larger studies are required to investigate this further.
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