Increased adverse event risk likely for children with certain LABAs

McMahon AW. Pediatrics. 2011;doi:10.1542/peds.2010-1720.

Children who are prescribed long-acting beta-adrenergic receptor agonists are likely at greater risk for adverse events, but just how great of a risk must be assessed further in additional studies, according to a study published online.

Ann W. McMahon, MD, of the FDA’s office of pediatric therapeutics, and colleagues reported on the results of a meta-analysis of 110 controlled clinical trials that looked at patients who were various ages and using long-acting beta-adrenergic receptor agonists (LABAs) and inhaled corticosteroids.

The researchers said the “composite event incidence difference for all ages was 6.3 events/1,000 patient-years (95% CI, 2.2-10.3) for using LABAs compared with not using LABAs,” with the greatest differences in the group of patients aged 4 to 11 years.

According to the researchers, there was an increased risk for adverse events across a range of age groups: 30.4 events/1,000 patients-years in those aged 4 to 11 years and 4.8 events/1,000 patient-years in the 18- to 64-year-old group. “Differences according to age were statistically significant,” they said.

The FDA recommended changes in the labeling of certain LABAs after results from three trials linked the use of LABAs to potential worsening asthma symptoms, hospitalization in both children and adults, and death in some patients with asthma.

Despite the safety warnings, appropriate use of LABAs can be beneficial in the treatment of asthma, according to the FDA.

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