Side-effect profile of brimonidine tartrate in children.

PURPOSE: To investigate brimonidine-related side effects and the efficacy of brimonidine in lowering intraocular pressure (IOP) in children with primary infantile and secondary glaucoma.

STUDY

DESIGN

Single-center, prospective, interventional, noncomparative case series.

PARTICIPANTS

Eighty-three children (mean age, 7.84 years) met the inclusion criteria.

METHODS

Medical records were reviewed to identify children with primary infantile or other forms of secondary pediatric glaucoma from birth to 15 years who received brimonidine as adjunctive therapy for glaucoma. The parents of the children who met the inclusion criteria completed a detailed questionnaire-based interview. The children were examined to assess weight, major systemic effects, and efficacy of adjunctive brimonidine therapy.

MAIN OUTCOME MEASURES: Questionnaire-based interview of parents to assess side effects of brimonidine and IOP-lowering effect of adjunctive brimonidine.

RESULTS

Parents reported symptoms in 70 of 83 children (84%). The most common side effects were excessive sleepiness and lethargy (76%), eye itching and rubbing (49%), and stinging and burning of the eyes (39%). Logistic regression analysis showed a statistically significant independent association between age and weight with lethargy and sleepiness. In symptomatic patients, symptoms' frequency increased with low weight (<20 kg) and in the young (<6 years). Mean IOP reduction after initiation of brimonidine, mainly as an adjunct, was 5+/-6.7 mmHg (P<0.001).

CONCLUSIONS

Side effects after the use of brimonidine in children were frequent. The weight and age of the child were important factors in predicting central nervous system side effects, especially excessive sleepiness and lethargy. Although brimonidine is effective in lowering IOP in children, alternative glaucoma therapy should be considered especially in children weighing <20 kg and those younger than 6 years.