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U.S. Department of Health and Human Services


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Long-Acting Beta-Agonists (LABAs)

Long-Acting Beta-Agonists (LABAs)
(July 16, 2010)
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Long-Acting Beta-Agonists (LABAs), a class of medications used for the treatment of asthma and chronic obstructive pulmonary disease (COPD), now have new recommendations in their drug label intended to promote their safe use in the treatment of asthma.

The agency required manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma. FDA’s decision to require changes to how these drugs are used in the treatment of asthma is based on analyses from the Salmeterol Multi-center Asthma Research Trial (SMART), the Salmeterol Nationwide Surveillance study (SNS), and a meta-analysis conducted by FDA in 2008.

FDA believes that when LABAs are used according to the recommendations outlined above and in the approved drug labels, the benefits of LABAs in improving asthma symptoms outweigh their risks of increasing severe asthma exacerbations and deaths from asthma.

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