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.
Although this deadly side effect is most common in children, adults with asthma are also included in the FDA warning. Patients who use LABAs for COPD (chronic obstructive pulmonary disease) are not included in the new warning.
The FDA action:
- Warns patients not to use LABAs by themselves, but always to combine them with other asthma-control medications.
- Warns asthma patients who must use LABAs to use them for the shortest possible time.
- Limits LABA use to patients whose asthma cannot be controlled with other drugs.
- Limits use of Advair and Symbicort. Although these products do contain asthma-control drugs, asthma patients should use these LABA-containing drugs for the briefest time possible.
- Compels LABA products to carry the FDA warning on their labels.
- Requires LABA makers to perform additional studies of the drugs' safety.
- Warns that LABA drugs do not relieve sudden-onset asthma attacks.
- 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.