FDA removes Boxed Warning from combination asthma therapies
After a long-running investigation, the US Food and Drug Administration has finally concluded that asthma can be treated with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) just as safely as with ICS alone.
The agency began a review of the medications in 2008, and in 2011 required drugmakers to conduct safety trials to evaluate LABAs when used in combination with ICS.
Based on a review of these trials, the previously-mandated Boxed Warning about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA.
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