Certain Asthma Drugs Risky for Kids

Some asthma medications are proving risky for children, according to emerging research. So-called long-acting beta-agonists—LABAs—have been linked with increased risks for significant complications, notes USA Today.

These complications include hospitalization, intubation, and death, known as so-called asthma composite outcome, said USA Today. When LABAs are used with inhaled corticosteroids (ICS), the risk decreases.

As we’ve explained, LABAs prevent the release of substances in the body that cause inflammation of airways in the lungs. Advair and Symbicort use a LABA with an inhaled steroid; Serevent and Foradil (made by Novartis and marketed by Merck & Co in the U.S.) only contain LABAs. All are approved to treat people whose asthma isn’t well controlled by other drugs including inhaled corticosteroids. The LABAs involved in the study are AstraZeneca’s Symbicort, GlaxoSmithKline’s Advair Diskus, Merck & Co’s Dulera, and Novartis AG’s Foradil.

“What we found overall was that there was a greater risk of the asthma composite outcome in the group that took LABAs as opposed to the group that didn’t. And, the risk was higher in the younger asthmatic population,” said study author Dr. Ann McMahon, who is also associate director of science and director of KidNet in the Office of Pediatric Therapeutics at the U.S. Food and Drug Administration (FDA), wrote USA Today. “… The agency is now pursuing doing a large randomized clinical trial in the context of LABAs and consistent ICS use,” McMahon added. Study results appear in the November’s Pediatrics.

We recently wrote that new warnings for Advair, Foradil, and Symbicort were finalized by the FDA and that the agency was planning on requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA also sought information on the design of these studies at a public advisory committee meeting in March 2010. Since, regulators mandated drugmakers conduct clinical trials with a group of 53,000 patients to test the safety of approved, inhaled asthma drugs.

The FDA began reviewing LABA safety in 2005 following issues with potential increases in serious complications. The first meta-analysis reviewing LABA safety was conducted in 2008 and led to an FDA advisory committee vote to limit LABA use to combination therapy with ICS medications, said USA Today. The current study, also a meta-analysis, endeavored to broaden the data derived from that earlier study.

This study reviewed 110 clinical trials involving about 61,00 asthmatics aged 4 and older. Some used LABAs; others did not, said USA Today. Research revealed that 6.3 more events per 1,000 patient-years took place in people treated with LABAs. In children aged four through 11, the difference was 30.4 events per 1,000 patient years; between 12-17, the difference was 11.6 per, said USA Today. Most adverse events were for hospitalizations over asthma flares.

“This meta-analysis suggests that we have more to learn. It looks like LABA alone may not be the right treatment for the pediatric population, ” said Dr. Allyson Larkin, assistant professor of pediatrics in the division of pulmonary medicine, allergy and immunology at Children’s Hospital of Pittsburgh, USA Today reported.

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