The boxed warning about asthma-related death has been removed from the labels of medicines that contain both an inhaled corticosteroid (ICS) and long-acting beta agonist (LABA). The safety label update was based after a Food and Drug Administration (FDA) review of four large clinical safety trials that showed treating asthma with LABAs along with ICS does not cause significantly more asthma-related side effects than treatment with ICS alone.
More information about the four trials referenced by the FDA are now included in the Warnings and Precaution section of the drug labels. The information states that LABA when used with ICS did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube (intubation), or asthma-related deaths compared to ICS alone.
In 2011, the FDA required manufacturers of fixed-dose combined drugs that contained LABA and ICS (GlaxoSmithKline, Merck, and Astra Zeneca) to conduct several large, 26-week, randomized, double-blind, active-controlled clinical safety trials to evaluate the risk of serious asthma-related events in patients taking LABAs in fixed-dose combination with an inhaled corticosteroid compared to ICS alone in patients with asthma.
The agency reviewed data involving more than 41,000 patients that demonstrated that use of ICS/LABA in fixed-dose combination does not significantly increase the risk of serious asthma-related events compared to ICS alone. The data also showed similar results for subgroups for gender, adolescents 12-18 years of age, and African Americans.
The black box warning has been lifted, but health care professionals and patients are still encouraged to report any adverse events with use of these products to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Safety Communication