Are Long-Acting β-Agonists Safe in Asthma Patients?

Large FDA-mandated studies showed no excess severe exacerbations when LABAs were used with inhaled corticosteroids.

In 2006, the Salmeterol Multicenter Asthma Research Trial showed excess asthma-related deaths in patients who used the long-acting β-agonist (LABA) salmeterol; however, many patients in that trial did not use concomitant inhaled corticosteroids (NEJM JW Gen Med Mar 1 2006 and Chest 2006; 129:15). Given resulting safety concerns, in 2010, the FDA placed a boxed warning on all asthma products that contained LABAs. To determine if concomitant use of inhaled corticosteroids (ICS) mitigated risk, the FDA mandated that the four manufacturers of LABA products perform randomized trials to compare the safety of ICS alone versus ICS/LABA combinations in adolescents and adults.

In a combined analysis of the four trials, no significant difference was no…

Reviewing Author

David J. Amrol, MD

Disclosures

Speaker’s BureauAstraZeneca; Incyte

David J. Amrol, MD

Disclosures

Speaker’s BureauAstraZeneca; Incyte

Are Long-Acting β-Agonists Safe in Asthma Patients?

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Reviewing Author