FDA: No excess risk of asthma death from LABA/ICS inhalers; warnings removed
Combination inhalers for asthma and COPD containing long-acting beta agonists (LABA) drugs along with inhaled corticosteroids can lose their black-box warnings about their previously-theorized risk of asthma-related death, the FDA announced.
The original boxed warning came in 2011 in the wake of a small number of asthma-related deaths among patients taking LABA monotherapy (without inhaled steroids). The deaths were never definitely attributed to the LABAs. As a precautionary measure, FDA ordered pharmaceutical companies producing the major ICS/LABA products to conduct large postmarketing safety trials. Those four clinical safety trials enrolling 41,297 patients showed no increase in serious asthma-related adverse events with the ICS/LABA combination inhalers as compared to inhaled steroid monotherapy:
No increased hospitalizations for asthma exacerbations
No excess rate of intubation
No increased risk of asthma-related death
Prespecified subgroup analyses among adolescents, men, and African-Americans (the groups considered to be at potentially higher risk) also showed no excess in adverse events with ICS/LABAs.
Long-acting beta-agonists include formoterol, salmeterol, and vilanterol. Drugs affected by the new labeling change include:
The drug companies got something else out of their several hundred million dollars of compelled investment in the safety trials. The studies showed that patients taking ICS/LABA combination inhalers had fewer asthma exacerbations, and the companies will be allowed to add this treatment benefit to the products’ labels (and advertise accordingly).