FDA: Boxed Warning About Asthma-Related Death Removed for LABA/ICS Combos

Long-acting beta agonists, when used with inhaled cortocosteroids, did not significantly increase the risk of asthma-related
Long-acting beta agonists, when used with inhaled cortocosteroids, did not significantly increase the risk of asthma-related

Based on a review of four clinical safety trials, the Food and Drug Administration (FDA) has concluded that medications that contain long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) do not significantly increase the risk of serious asthma-related adverse events. 

Specifically, these recently completed trials, which were required by the FDA in 2011, demonstrated that compared to ICS alone, the use of LABA + ICS was not significantly associated with an increased risk of asthma-related hospitalizations, intubation, or asthma-related death. In addition, the studies also showed that the use of this combination was more effective in reducing asthma attacks compared to ICS alone. 

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Given the results of these trials, the Boxed Warning regarding asthma-related death has been removed from the drug labeling for medications that contain both an ICS and LABA. Medications that include this combination include Advair Diskus (fluticasone and salmeterol; GlaxoSmithKline), Advair HFA (fluticasone and salmeterol; GlaxoSmithKline), Airduo Respiclick (fluticasone and salmeterol; Teva), Breo Ellipta (fluticasone and vilanterol; GlaxoSmithKline), Dulera (mometasone and formoterol; Merck), and Symbicort (budesonide and formoterol; AstraZeneca). 

With regard to LABA monotherapy, the Boxed Warning will continue to state that use of LABA alone without an ICS to treat lung inflammation is associated with an increased risk of asthma-related death. 

Clinicians are being advised to refer to the most recently approved drug labeling when making decisions on treatment. Data from these studies have been added to labeling in the Warnings and Precautions section. 

For more information visit FDA.gov.