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  • FDA Date: 06/02/2010

    Foradil (formoterol fumarate) FDA Drug Safety Communication

    Drug Labels Now Contain Updated Recommendations on the Appropriate Use of Long-Acting Inhaled Asthma Medications Called Long-Acting Beta-Agonists (LABAs)

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    Long-Acting Beta-Agonists (LABAs), a class of medications used for the treatment of asthma and chronic obstructive pulmonary disease (COPD), now have new recommendations in their drug label intended to promote their safe use in the treatment of asthma. The new recommendations do not apply to the use of LABAs for the treatment of COPD.

    In February 2010, the agency announced it was requiring manufacturers to revise their drug labels because of 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. The new recommendations in the updated labels state:

    - Use of a LABA alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma.

    - LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

    - LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.

    - Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (eg, discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.

    - Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure adherence with both medications.

    Examples of U.S.-marketed LABAs include: Brovana Inhalation Solution (arformoterol tartrate); Foradil Aerolizer (formoterol fumarate); Perforomist Inhalation Solution (formoterol fumarate); and Serevent Diskus (salmeterol xinafoate).

    Examples of U.S.-marketed combination products include: Advair Diskus (salmeterol/fluticasone); Advair HFA (salmeterol/fluticasone); and Symbicort (formoterol/budesonide).

    View the full FDA Drug Safety Communication on FDA.gov