Balancing the Benefits and Risks of Inhaled Long-Acting Beta-Agonists — The Influence of Values

In December 2008, the Food and Drug Administration (FDA) convened a joint meeting of the Pediatric Advisory Committee, the Pulmonary–Allergy Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee (of which I am a member) to review the risks and benefits of inhaled long-acting beta-agonists (LABAs) for the treatment of asthma in adults and children. Committee members were asked to weigh the public health implications of real and serious but relatively infrequent occurrences of severe asthma exacerbations and asthma-related death against the symptomatic benefits of bronchodilation and asthma control. The drugs in question included single-agent LABA products . . .

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Dr. Kramer is an associate professor of medicine and executive director of the Clinical Trials Transformation Initiative at the Duke Translational Medicine Institute, Duke University Medical Center, Durham, NC, and a voting member of the Drug Safety and Risk Management Advisory Committee of the FDA
http://content.nejm.org/cgi/content/full/360/16/1592