Posted: Oct 25, 2011 10:41 PM
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.
At a December 2008 meeting, an FDA advisory panel split on the question of whether LABA-inhaled corticosteroid combination drugs should be used to treat children, with 13 panelists concluding that the benefits outweighed the risks in children and 11 concluding that they did not.
In the ruling early last year, the FDA concluded that children and teens who require a long-acting beta-agonist use only combination agents that include an asthma controller medication such as an inhaled steroid.
McMahan says studies designed to address the question of LABA safety in children and teens are in the planning stages.
Pulmonary specialist Len Horovitz, MD, of Lenox Hill Hospital in New York City, says LABAs are an important addition to the choices of asthma-control drugs.
Horovitz agrees that studies addressing the safety of LABA-inhaled corticosteroid combination drugs in children are needed.
"Are these drugs safe or should we be using some other approach such as inhaled corticosteroids with a short-acting bronchodilator in children?" he says. "Right now, we don't really have a good answer to this question."