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Some Asthma Drugs Raise Risk of Complications, Especially in Kids: Study
Date:10/25/2011

ucted. As a result of that analysis, an FDA advisory committee voted to restrict the use of LABAs to be used in combination with inhaled corticosteroids. The current meta-analysis was undertaken to expand the knowledge gained from that initial analysis.

The current meta-analysis included 110 clinical trials with a nearly 61,00 people with asthma. The trials included people aged 4 and up. Some used LABA medications; some did not.

Overall, the researchers found that 6.3 more events per 1,000 patient-years occurred in people taking LABAs compared to those not taking the medication. Events included asthma-related hospitalizations, intubations and deaths.

In children between the ages of 4 and 11, the difference between the two groups was 30.4 events per 1,000 patient years. In children between the ages of 12 and 17, the difference was 11.6 per 1,000 patient years.

McMahon noted that most of the complications in children were hospitalizations related to asthma flares. Asthma-related deaths and intubations were rare complications, according to the study.

She said the study was designed to identify trends, not look at individual cases, so "we don't have a lot of answers about why the asthma composite outcomes were higher in the younger age groups."

"Sometimes we find that products that work well in adults don't work well in kids," said senior study author Dr. Dianne Murphy, director of the Office of Pediatric Therapeutics at the FDA. And in the case of LABAs, there could be numerous explanations. It may be that asthma is a different disease in children than in adults, or it may have to do with children's smaller airways. Or, she said, it could be that children might not always let their parents know when their asthma symptoms are getting worse.

Whatever the reason for the higher risk of complications in children, Murphy said, what's important to take away from this study is that "if your child requires a LABA, they ought to be on
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