FDA Drug Safety Communication: New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)
Due to safety concerns, the U.S. Food and Drug Administration (FDA) is requiring changes to how long-acting inhaled medications called Long-Acting Beta-Agonists (LABAs) are used in the treatment of asthma. These changes are based on FDA’s analyses of studies showing 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 (see Data Summary below).
LABAs are approved as single-ingredient products (Serevent and Foradil) and as an ingredient in combination products containing inhaled corticosteroids (Advair and Symbicort) for the treatment of asthma and chronic obstructive pulmonary disease (COPD). They work by relaxing muscles in the airway and lungs. This helps patients breathe easier, and lessens symptoms such as wheezing and shortness of breath. The new recommendations only apply to the use of LABAs in the treatment of asthma.