FDA's recommendations on the use of long-acting {beta}2 agonists in the management of asthma.
The revised labeling for long-acting β(2) 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.
Robinson
Christie A
CA
Department of Clinical Pharmacy, University of California San Francisco, USA. robinsonc@pharmacy.ucsf.edu
D000318:Adrenergic beta-Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D006801:Humans; D015201:Meta-Analysis as Topic; D015337:Multicenter Studies as Topic; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014486:United States Food and Drug Administration
D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D003692:Delayed-Action Preparations