TUESDAY, Oct. 25 (HealthDay News) -- When used alone, the asthma
medications known as long-acting beta-agonists are associated with
an increased risk of serious complications, new research
What's more, the increased risk of complications, including
hospitalization, intubation and death (called the asthma composite
outcome), associated with the use of these medications was even
higher in children than in adults.
However, when long-acting beta-agonists (LABAs) are used in
combination with inhaled corticosteroids, the increased risk
appears to dissipate.
Products that only contain a LABA are marketed under the brand
names Foradil and Serevent in the United States, while they are
sold under the brand names Symbicort and Advair when combined with
"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, associate director of science and director of KidNet in the Office of Pediatric Therapeutics at the U.S. Food and Drug Administration.
"The other important thing is that in a smaller subgroup that took LABAs and inhaled corticosteroids [ICS], and took those consistently, we did not find that the risk was elevated. But, this subgroup was rather small, so the results regarding ICS are somewhat inconclusive. The agency is now pursuing doing a large randomized clinical trial in the context of LABAs and consistent ICS use," McMahon said.
Results from the current study are published in the November
The FDA first began looking into the safety of LABAs in 2005
when concerns about a possible increase in serious complications
were first raised. In 2008, the first meta-analysis examining the
safety of LABAs was conducted. 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
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
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
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
"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 a
steroid with it." And, she added, if your child's symptoms aren't
improving on the combination medication, let your child's doctor
"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, and we don't use it alone. But, combining the two potentially may not increase the bad outcomes," said Dr. Allyson Larkin, an assistant professor of pediatrics in the division of pulmonary medicine, allergy and immunology at Children's Hospital of Pittsburgh.
Learn more about long-acting beta-agonists from the
U.S. Food and Drug Administration.