FDA to review findings, researcher says
THURSDAY, Sept. 1, 2016 (HealthDay News) — Children using a combination long-acting beta agonist/steroid inhaler do not have any greater risk of harm than children using a steroid inhaler alone, according to a study published in the Sept. 1 issue of the New England Journal of Medicine.
Stanley Szefler, M.D., director of pediatric asthma research for the University of Colorado School of Medicine in Aurora, and colleagues recruited 6,208 children between 4 and 11 years old. They were randomly assigned inhalers containing a combination of salmeterol and fluticasone, or fluticasone alone.
Of all the patients, 27 in the combination drug group had a serious asthma-related event that required hospitalization, compared with 21 in the steroid-only group. There were no deaths, and no emergencies that required endotracheal intubation.
“The next step is for the FDA to assemble all the available studies, make their own interpretation, and determine how that would affect product labeling,” Szefler told HealthDay.
Several authors disclosed financial ties to pharmaceutical companies, including GlaxoSmithKline, which manufactures Advair (fluticasone/salmeterol) and funded the study.
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