New warning and safety controls for long-acting beta agonists

The FDA announced that long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma. FDA analyses showed that use of these drugs is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults, and death in some patients with asthma.

The drugs involved include Serevent Diskus (salmeterol, from GlaxoSmithKline), Foradil Aerolizer (formoterol, from Schering), Advair Diskus (fluticasone, from GlaxoSmithKline), and Symbicort (budesonide/formoterol, from AstraZeneca). Manufacturers of these products will be required to include the new warning in the Prescribing Information, along with taking other steps to reduce the overall use of these medicines. The new recommendations only apply to the use of LABAs in the treatment of asthma.

To ensure the safe use of these products:
  • The use of LABAs is contraindicated without the use of an asthma controller medication such as an inhaled corticosteroid. Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
  • LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications. 
  • LABAs 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. Patients should then be maintained on an asthma controller medication. 
  • 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 compliance with both medications.
For more information visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm.