Statement of the American Lung Association on the FDA’s Changes to the Use of Certain Long-Acting Inhaled Medications called Long-Acting Beta-Agonists (LABAs)

Chief Medical Officer Norman H. Edelman, M.D

(February 19, 2010)

The U.S. Food and Drug Administration (FDA) has issued a safety announcement regarding the use of long-acting inhaled medications called Long-Acting Beta-Agonists (LABAs) in the treatment of asthma. It has been known for some time that these medications can lead to increased risk of severe exacerbation of asthma symptoms when not used correctly.  The new FDA requirements will strengthen existing cautions in labeling and medication guides. 

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. When used correctly, this helps patients breathe easier, and lessens symptoms such as wheezing and shortness of breath.

According to the FDA, to ensure the safe use of these products:

  • They should not be used without also using an asthma controller medication, usually an inhaled corticosteroid.
  • They should only be used long-term in patients whose asthma cannot be controlled on asthma controller medications.
  • They should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved.
  • Children who require the addition of a LABA to an inhaled corticosteroid should use a combination product, which makes it easier for them to take the medicines correctly.

It is important to note that although LABAs are also used for COPD, the new recommendations only apply to their use for treating asthma. There is no evidence that people with COPD who use LABAs are at any increased risk.

The American Lung Association is closely monitoring the situation and recommends that patients currently using a LABA not to stop or change their medications. Patients should discuss any questions they have about the use of LABAs with their healthcare provider.

For questions about lung health, call the American Lung Associations Lung HelpLine at 1-800-548-8252.