Drug Safety and Availability > FDA Drug Safety Communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS)

Drug Safety and Availability > FDA Drug Safety Communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS)

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A U.S. Food and Drug Administration (FDA) review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. In 2011, we required the drug companies that market LABAs to conduct these trials to evaluate the safety of LABAs when used in combination with ICS, and we reviewed the results of these recently completed trials.

Based on our review, the Boxed Warning, our most prominent warning, about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA. A description of the four trials is now also included in the Warnings and Precautions section of the drug labels. These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone.

Using LABAs alone to treat asthma without an ICS to treat lung inflammation is associated with an increased risk of asthma-related death. Therefore, the Boxed Warning stating this will remain in the labels of all single-ingredient LABA medicines, which are approved to treat asthma, chronic obstructive pulmonary disease (COPD), and wheezing caused by exercise. The labels of medicines that contain both an ICS and LABA also retain a Warning and Precaution related to the increased risk of asthma-related death when LABAs are used without an ICS to treat asthma.

Medicines that contain both an ICS and LABA are FDA-approved to treat both asthma and COPD. ICS medicines help decrease inflammation in the lungs. This inflammation can lead to breathing problems. LABAs help the muscles around the airways in the lungs stay relaxed to prevent symptoms such as wheezing, coughing, chest tightness, and shortness of breath. ICS/LABA medicines are marketed under several brand names, including Advair, Airduo, Breo, Dulera, and Symbicort. 

For more information, please visit: Long-acting beta agonists (LABAs).