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

Abstract

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 (salmeterol, or Serevent [GlaxoSmithKline], and formoterol, or Foradil [Novartis]) and LABAs available in combination with inhaled corticosteroids (fluticasone plus salmeterol, marketed as Advair [GlaxoSmithKline], and budesonide plus formoterol, marketed as Symbicort [AstraZeneca]). The FDA's continuing approval of an asthma indication for these agents was at stake.