FDA Officials Find No Increased Risk of Serious Outcomes with LABAs Used with ICS

A US FDA review of 4 large clinical safety trials has concluded that treating patients with asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone, prompting removal of a boxed warning about the potential effects.

FDA officials evaluated 4 recently completed clinical trials involving 41,297 patients, 3 conducted in patients 12 years and older, and one in children 4 to 11 years. Patients in all the trials were treated for 6 months to evaluate serious asthma outcomes including asthma-related death, intubation, or hospitalization. The results of all trials showed that the use of LABA with ICS does not significantly increase the risk of serious asthma outcomes compared to ICS alone. The trials also showed that ICS/LABA combination medicines were more effective in decreasing asthma attacks (e.g., the need to use oral corticosteroids) compared to ICS alone. This additional information has been added to the ICS/LABA labels.

"Using LABAs alone to treat asthma without an ICS to treat lung inflammation is associated with an increased risk of asthma-related death. Therefore, the Boxed Warning stating this will remain in the labels of all single-ingredient LABA medicines," according to an FDA Safety Announcement on the issue. The labels of medicines that contain both an ICS and LABA also retain a warning and about the increased risk of asthma-related death when LABAs are used without an ICS to treat asthma.

The FDA referred health care professionals to the most recently approved drug labels for recommendations on using ICS/LABA medicines. Patients and parents/caregivers are urged to discuss questions with pharmacists and other health care professionals.