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FDA Updates U.S. Product Labels for LABA-Containing Medications

The FDA has released final label revisions for respiratory medications that contain an active ingredient known as a long-acting beta-agonist (LABA). This follows the FDA communication in February 2010 requesting all manufacturers of LABA-containing medications to undertake class-labeling changes. The FDA made label revisions to both single ingredient and combination LABA-containing medications. For the treatment of asthma, single ingredient LABAs should only be used with an asthma controller medication, such as an inhaled corticosteroid; they should not be used alone.

The updated label for combination asthma medications, including Astra- Zeneca‚Äôs Symbicort®, provides guidance on how these products should be prescribed to treat asthma:

• Combination LABA-containing medications should only be used for people not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA.

• Once asthma control is achieved and maintained, an asthmatic person should be assessed at regular intervals, and therapy should be stepped down (in other words, discontinue Symbicort) if possible without loss of asthma control, followed by maintenance with a long-term asthma control medication, such as an inhaled corticosteroid.


This article was originally published in Coping® with Allergies & Asthma magazine, Spring/Summer 2010.