Feb. 19, 2010 -- The long-acting asthma drugsSerevent and Foradil should never be used alone, the FDA has ruled.
The FDA also moved to limit use of the combination drugs Advair and Symbicort by asthma patients. All of the drugs contain a class of drugs called long-acting beta agonists (LABAs), which can provoke a sudden, fatal asthma attack.
Establishes a new risk management program for patients who must use LABAs.
"The risks of hospitalization and poor outcomes are of particular concern for children; parents need to know that their child with asthma should not be on a LABA alone," Dianne Murphy, MD, FDA director of pediatric therapeutics, says in a news release.
The FDA has not banned the use of single-agent LABA drugs because not all asthma control medications can be combined with these inhaled medications.
The FDA action comes in the wake of the December 2008 recommendation by an outside advisory panel to stop the use of Serevent and Foradil as standalone treatments.