The FDA has ordered clinical trials to test the safety of Long-Acting Beta-Agonists (LABAs) when used in combination with inhaled corticosteroids.  The clinical trials will involve 53,000 patients.  The specific drugs to be studied are Symbicort (budesonide and formoterol), Advair Diskus (fluticasone and salmeterol), Dulera (mometasone and formoterol), and Foradil (formoterol).

LABAs are used to treat asthma by relaxing the muscles of the airways.  However, they can increase the risk of severely worsening asthma symptoms that can lead to hospitalizations and death.

The FDA previously issued a safety announcement on LABAs on June 2, 2010 regarding their use in asthma treatment.  The FDA ordered that the LABA labels be changed to state the following:

• 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.