US COPD Coalition

FDA Lifts Black Box Warning from Combination Long-Acting Bronchodilator/Corticosteroid Inhalers


In 2011, the Food & Drug Administration ordered post-market safety trials to be conducted on combination long-acting beta agonist (LABA) and inhaled corticosteroid (ICS) inhalers. This review was prompted by the discovery that using LABA inhalers alone resulted in an increased risk of asthma-related death. LABAs are medications that relax the muscles of the airways so they don’t spasm and constrict. Inhaled corticosteroids are medicines that reduce airway inflammation. The FDA wanted to learn whether treating asthma patients with ICS alone was safer than using a LABA/ICS combination.

Based on the FDA’s review of the recently completed post-market safety trials, they have concluded that there is no significant risk of serious asthma outcomes with long-acting beta agonists used in combination with inhaled corticosteroids. This is important for patients with COPD because the same LABA/ICS medications that are used to treat asthma are also used in the treatment of COPD.

As a result of the FDA’s review, the black box warning, which is the FDA’s most prominent warning, is being lifted from LABA/ICS combination medications. The warnings will remain on inhalers that only contain long-acting beta-agonists. Brand names of combination LABA/ICS medications include Advair, Airduo, Breo, Dulera, and Symbicort.