The Food and Drug Administration (FDA) has removed a boxed warning from asthma drugs that contain both an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA).
The change came after four large clinical safety trials showed the fixed-dose combination did not significantly increase the risk of asthma-related hospitalizations or deaths compared to ICS alone, according to the FDA. The trials also showed such drugs were effective in decreasing asthma attacks.
In 2011, the FDA required GlaxoSmithKline, Merck and Astra Zeneca to conduct randomized, double-blind, active-controlled clinical safety trials on the combination drugs. Drug labels will include information on those trials, which included 41,297 patients.
Medications still will contain warnings that using LABAs to treat asthma without an ICS is associated with an increased risk of death. Physicians can learn more at http://bit.ly/2zarwAC.
Patients and health care professionals can report adverse events to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or by calling 800-332-1088.
