Advair, manufactured by GlaxoSmithKline, was approved by the FDA to treat asthma and chronic obstructive pulmonary disease (COPD) in 2000. Advair belongs to a class of drugs called long-acting beta 2-adrenergic agonists (LABA) which are long-acting bronchodilator medicines. Medical studies suggest that the active ingredient, salmeterol, found in Advair, and its sister drug, Serevent, may be linked with worsening asthma symptoms and responsible for an increase in the number of asthma related deaths in adults and children.
These studies found that patients who inhaled the long-acting beta-agonists salmeterol (trade names Serevent and Adair) were 3.5 times more likely to die from asthma and 2.5 times more likely to be hospitalized compared with those taking a placebo.
On November 18, 2005, FDA alerted health care professionals and patients that Advair had been associated with possible increased risk of worsening wheezing (bronchospasm) in some people, and requested that manufacturers update warnings in their existing product labeling. This information has now been included in updated labeling.
A study, published in June 2006, suggested that while Advair and Serevent (salmeterol) relieve asthma symptoms, they also promote bronchial sensitivity and inflammation. It also suggested that salmeterol may more than triple the risk of death from asthma-related complications to patients who inhaled these medications. The FDA issued an updated health advisory based on the study findings and requested that the manufacturers of Advair Diskus and Serevent Diskus update their labels to warn of their potential for causing severe asthma episodes and death.