Children in the 4-11 age group taking LABAs were 67 percent more likely to have an asthma-related hospitalization than those who weren’t taking the medication.
A report released by the U.S. Food and Drug Administration finds that a class of drugs, LABAs or long-acting-beta-agonists, may increase children’s risk of being hospitalized for a serious asthma attack. However, the study also found that when LABAs are used in combination with inhaled corticosteroid medications, that extra risk diminishes significantly. “These studies confirm our recommendations at the FDA that are already (on drug labels) for children and adolescents to use inhaled corticosteroids and LABA’s together in one asthma product,” says Ann McMahon, the lead researcher for the study.
According the Centers for Disease Control and Prevention, seven million children in the U.S. have asthma, and the rate of incidence has been climbing steadily in recent years. To combat the symptoms of asthma, including coughing and wheezing, many children and adults alike are prescribed LABAs to relax muscles around the airway.
The study, published in the journal Pediatrics, reviewed 110 controlled clinical trials including 60,654 patients comparing the risk of LABA use with no LABA use for patients ages 4 to 11, 12 to 17, 18 to 64, and 64 and older. The study also analyzed the effects of inhaled corticosteroids.
The study’s authors found that when compared to all patients who didn’t take LABAs, children and adults who were prescribed the drugs were 27 percent more likely to end up in the hospital or in rare cases, require intubation or die due to a severe asthma attack. More telling was that this extra risk was greatest in the youngest study group, those aged four to 11. Children in that age group taking LABAs were 67 percent more likely to have an asthma-related hospitalization than those who weren’t taking the medication.
But a small number of patients from all age groups who were regularly taking inhaled corticosteroids in combination with LABA seemed to have no extra risk of hospitalization due to an asthma attack. “Although we were able to be somewhat reassured... it was a small enough sample that we didn't feel entirely confident, and we need to have further analysis," McMahon told Reuters.
The finding of an extra risk in people taking LABAs alone isn't new. Last year, after other research suggested a risk, the FDA began requiring drug-makers to write on LABA labels that the drugs should not be used without a long-term asthma control medication like an inhaled corticosteroid.
Some asthma medications already on the market, including GlaxoSmithKline's Advair and AstraZeneca's Symbicort, contain both a LABA and corticosteroid and the results of the new study help to confirm the FDA recommendation that such combined products should be used for children with asthma.
October 27, 2011
http://www.burrillreport.com/article-common_asthma_drugs_may_boost_health_risk_for_children.html