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U.S. Department of Health and Human Services

Safety

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Long-Acting Beta Agonists (LABAs) Label Change

  • Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder)
  • Advair HFA Inhalation Aerosol (fluticasone propionate and salmeterol xinafoate)
  • Brovana Inhalation Solution (arformoterol tartrate)

  • Foradil Aerolizer (formoterol fumarate inhalation powder)
  • Foradil Certihaler (formoterol fumarate inhalation powder)
  • Perforomist (formoterol fumarate) Inhalation Solution

  • Serevent Diskus (salmeterol xinafoate inhalation powder)
  • Symbicort Inhalation Aerosol (budesonide and formoterol)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2010

Summary View

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 (e.g., 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.

BOXED WARNING

WARNING: ASTHMA-RELATED DEATH
  • Long-acting beta2-adrenergic agonists (LABA), increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of the LABA...

WARNINGS AND PRECAUTIONS

ASTHMA RELATED DEATH
  • Long-acting beta2-adrenergic agonists increase the risk of asthma-related death. The safety and efficacy of LABA in patients with asthma have not been established. All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication...