FDA revises labeling for long-acting beta-agonists

The FDA has finalized label revisions for both single ingredient and combination long-acting beta-agonist-containing respiratory medications for the treatment of asthma. This action follows the February 2010 FDA announcement that it would require 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 long-acting beta-agonists for the treatment of asthma.

 The new recommendations in the updated labels state:

  • Use of a long-acting beta-agonist alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated in the treatment of asthma
  • Long-acting beta-agonists should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids
  • Long-acting beta-agonists 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 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 long-acting beta-agonist to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a long-acting beta-agonist, to ensure adherence with both medications

In addition, the Boxed Warning, and other relevant sections of the label, have been revised to inform healthcare professionals and patients that long-acting beta-agonists, when used as single ingredient products, increase the risk of asthma-related death based on a large placebo-controlled study with salmeterol. FDA considers this risk to be a class effect of all long-acting beta-agonists.

FDA-approved long-acting beta-agonists indicated for the treatment of asthma include Serevent Diskus (salmeterol, from GlaxoSmithKline), Foradil Aerolizer (formoterol, from Schering), Advair Diskus and Advair HFA (salmeterol/fluticasone, from GlaxoSmithKline), and Symbicort (formoterol/budesonide, from AstraZeneca).

For more information visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213836.htm.