FDA: Put Tougher Warnings on Some Asthma Drugs

On Nov. 18, the FDA issued a Public Health Advisory after recent study findings raised concerns about use of the asthma products Serevent Diskus, Advair Diskus and Foradil Aerolizer. Use of these bronchodilating agents, which contain the long-acting beta 2-adrenergic agonists salmeterol and formoterol, has been associated with increased risks for severe asthma exacerbations and asthma-related deaths.

Specifically, FDA officials asked the manufacturers of these products to revise the current product labels to include additional warning information. The FDA also asked that a medication guide containing FDA-approved patient information be distributed with each prescription.

One large U.S. study -- the Salmeterol Multi-center Asthma Research Trial, or SMART -- that assessed the safety of salmeterol added to usual asthma therapy showed an increase in asthma-related deaths in patients who received the drug versus a placebo. Two smaller studies found similar risks associated with use of formoterol. Data from these and related clinical trials prompted FDA officials to call for the label revisions to the three products.

LABAs are used for long-term control and prevention of asthma symptoms; for preventing exercise-induced bronchospasm in adults and children; and for long-term control of bronchospasm in adults with chronic obstructive pulmonary disease. The new warnings pertain only to LABA use for asthma. At this time, information is not available regarding LABA use for exercise-induced bronchospasm or COPD.

Included in the FDA advisory are these recommendations:

Additional information about these products is available online from the FDA's Center for Drug Evaluation and Research.