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Friday, February 19, 2010

FDA announces new safety labeling recommendations for long-acting beta2 agonists

The United States Food and Drug Administration (FDA), after continued analysis of clinical trial data on LABAs, has announced additional labeling requirements on formoterol and salmeterol, as well as the combination products that include these drugs.

Black box warnings are currently in place for both formoterol and salmeterol about the possible increased risk of death and limiting use to those patients whose asthma is not controlled on inhaled corticosteroids (ICS). Current labeling also cautions against use of LABAs as monotherapy for asthma and for management of acute exacerbations.

The new FDA labeling requirements mandate labeling language that LABAs are contraindicated as monotherapy, must be used in conjunction with ICS therapy, should be used for short durations to re-establish control of asthma, then discontinued, and must be used in a combination product for patients who require both LABAs and ICS to manage their asthma to ensure that both medications are used by the patient.

In the latest GINA guidelines (2009), it was proposed that LABAs should not be given as monotherapy, but as adjunct to ICS therapy. These recommendations were based on the paper of Nelson et al (Chest, 2006 Jan;129(1):15-26) and a thorough analysis of the literature. They are in line with the FDA announcement.

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  1. For more on the FDA's perspective on this topic, see the following article from this week's New England Journal of Medicine:

  2. The AAAAI has posted the press conference on this topic that took place during last week's Annual Meeting in New Orleans. Visit