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
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
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,”
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.