The FDA told the manufacturers of fluticasone-salmeterol powder discs (Advair Diskus), formoterol fumarate inhalation powder (Foradil Aerolizer), and salmeterol xinafoate inhalation powder (Serevent Diskus) to update product labels with new warnings and a medication guide that states these medications may increase the chance of severe episodes of asthma that may lead to death. Each of these products contains a long-acting beta 2-adrenergic agonist (LABA). According to the FDA, although LABAs decrease the frequency of asthma episodes, these medications may make asthma episodes more severe when they occur.

In one asthma study, an increased number of people taking a LABA, in addition to their usual asthma care, died from asthma compared with people taking a placebo in addition to their usual asthma care. The FDA notes that the number of asthma deaths in the study was small.

The warnings concern the use of LABAs to treat asthma; information is not available to know whether there are similar concerns when LABAs are used for exercise-induced bronchospasm or chronic obstructive pulmonary disease.

The medication guide will be given to patients when they receive or refill a prescription for LABAs.