FDA's Recommendations on the Use of Long-Acting {beta}2 Agonists in the Management of Asthma (October).
Ann Pharmacother. 2010 Sep 14;
Authors: Robinson CA
The revised labeling for long-acting β2 agonists (LABAs) by the Food and Drug Administration (FDA) is controversial and in part is inconsistent with the 2007 National Asthma Education and Prevention Program asthma guidelines. Two large randomized controlled studies, the Serevent Nationwide Surveillance (SNS) study and the Salmeterol Multicenter Asthma Research Trial (SMART), and a 2008 meta-analysis conducted by the FDA were the main sources of information used to determine the label changes. A paucity of large, well-designed, controlled, prospective studies evaluating the asthma-related risks associated with LABAs makes it difficult to reach a consensus regarding how best to use LABAs in patients with asthma.
PMID: 20841520 [PubMed - as supplied by publisher]