Advair Diskus, Serevent Diskus Product Labels Updated
Manufacturer changes labels, issues new medication guides in response to FDA advisory
WEDNESDAY, May 17 (HealthDay News) -- In response to a U.S. Food and Drug Administration public health advisory issued in November 2005, GlaxoSmithKline has updated the product labels for its Advair Diskus (fluticasone propionate; salmeterol xinafoate) and Serevent Diskus (salmeterol xinafoate) to note that the medications may increase the risk of severe asthma episodes or death when severe episodes occur. GlaxoSmithKline has also issued new medication guides, according to an update published this week by the FDA.
Both medications contain long-acting beta 2-adrenergic agonists (LABAs). In its 2005 advisory, the FDA cautioned that LABAs, including Foradil Aerolizer (formoterol fumarate inhalation powder), should not be used as first-line asthma treatments and should only be added to a treatment plan if other medicines are ineffective. The FDA also warned patients not to use LABAs to treat worsening or sudden asthma, but instead rely on a short-acting bronchodilator.
In making its recommendations, the FDA pointed to a study showing that an increased number of people died who were taking a LABA in addition to their usual asthma care compared to people who were taking a placebo in addition to their usual asthma care, even though the overall number of asthma deaths was small. "The Medication Guide has information about these risks for patients and caregivers in language approved by FDA and will be given to patients when a prescription for a LABA is filled or refilled," according to the 2005 advisory.