Oct. 25, 2011 -- Children are more vulnerable than adults to rare but potentially life-threatening events associated with asthma drugs known as long-acting beta-agonists (LABAs), a new analysis from the FDA shows.
The analysis is published in Pediatrics.
Early last year, an FDA panel concluded that the single-agent LABA inhalers Serevent and Foradil should only be used in combination with an asthma controller (long-term maintenance drug), such as an inhaled corticosteroid, to reduce the risk for a severe, fatal asthma attack associated with LABAs.
LABAs help control and prevent airway spasms during asthma attacks. But they do not treat the inflammation that produces airway constriction, and that's where the corticosteroids help.
The agency also concluded that use of the widely prescribed combined LABA and inhaled corticosteroid products Advair and Symbicort should be restricted to patients whose asthma was not adequately controlled with other asthma controller drugs as a first option. The FDA also said that children and teens who require LABAs take only combination drugs containing both an inhaled corticosteroid and a LABA.
Ann W. McMahon, MD, of the FDA's office of pediatric therapeutics, says the new analysis does not change these recommendations.
FDA researchers examined data from 110 studies that included about 61,000 children and adults with adverse asthma-related events including hospitalizations, intubations (using an inserted tube to help a patient breathe), and deaths.
They compared the risk of LABA use to non-LABA medication use for four age groups: 4 to 11, 12 to 17, 18 to 64, and 65 and older.
The analysis confirmed that patients who used a long-acting beta-agonist had a greater risk for asthma-related adverse events than patients who did not use them, and that the risk among LABA users was greatest among children younger than age 12.
The overall risk for asthma-related hospitalizations, intubations, and death among LABA users was 30.4 events per 1,000 patient years (a statistical method for measuring risk) for the youngest LABA users, 11.6 events per 1,000 patient years for teen users, and 4.8 events per 1,000 patient years for adults younger than age 65.
Use of an inhaled corticosteroid with a LABA appeared to lower the risk of the adverse events in both adults and children. But McMahon says more research is needed to confirm the finding.
"We were somewhat reassured by the fact that both adults and children who took inhaled corticosteroids tended to have no additional risk associated with LABA use, but [the number of people in our study] was small," she tells WebMD.