The FDA has removed a boxed warning on medicines delivering a combinations of inhaled corticosteroid (ICS) and long-acting beta agonists (LABA) drugs.
The FDA has removed a boxed warning of asthma death risk on medicines delivering a combinations of inhaled corticosteroid (ICS) and long-acting beta agonists (LABA) drugs.
The agency required GlaxoSmithKline, Merck, and AstraZeneca, which all manufacture fixed-dose combination drugs containing an ICS and LABA to conduct several large, randomized, double-blind, active-controlled clinical safety trials to evaluate the risk of asthma-related events for the combination compared with ICS alone.
The primary efficacy endpoint was asthma exacerbation or an in-patient hospitalization or emergency department visit due to asthma requiring systemic corticosteroids. The 4 trials included more than 41,000 patients with subgroup analyses for gender, adolescents (12 to 18 years old), and African Americans.
After reviewing the 26-week trials, the FDA determined that ICS/LABA inhalers did not result in significantly more serious asthma-related side effects than ICS alone in either the overall trial population or the subgroups.
“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,” the FDA determined.
A description of the 4 trials will be included in the warnings and precautions section of the drugs’ labels. The boxed warning changes apply to Advair Diskus, Advair HFA, Airduo Respiclick, Breo Ellipta, Dulera, and Symbicort.
The FDA recommends that healthcare professionals refer to the most recently approved drug labels and that patients and caregivers talk to their healthcare professionals about concerns.