The Advair Diskus inhaler contains a combination of fluticasone and salmeterol and is used to treat asthma. Fluticasone and salmeterol shrink the swelling in the airways and relax and open air passages in the lungs. Advair was approved in 2000, by the FDA and is made by GlaxoSmithKline.
The FDA, on November 15, 2005 issued a public health advisory about potentially fatal side effects from two GlaxoSmithKline asthma drugs. The agency is asking the maker of the drugs, Advair Diskus and Serevent Diskus, to add warnings to their labels that these medications may increase the chance of severe asthma episodes, and death when those episodes occur.
Advair Increase The Chance Of Severe Asthma
Advair is GlaxoSmithKline’s biggest product, with $4 billion in sales during the first nine months of 2005. Serevent’s sales were $450 million. Advair is a long-acting beta 2-adrenergic agonist, or LABA, which provides asthma relief by relaxing muscles around the airways to the lungs. Although they can reduce the number of asthma episodes, the FDA says they “may increase the chances of a severe asthma episode when they do occur.
In one study, the agency says, “an increased number of people taking a LABA in addition to their usual asthma care died from their asthma compared to people taking a placebo in addition to their usual asthma care, although the number of asthma deaths in the study was small.
In August 2003, the FDA announced the addition of new safety information and warnings to the labeling for drug products that contain salmeterol. The new labeling includes a boxed warning about a small, but significant, increased risk of life-threatening asthma episodes or asthma-related deaths observed in patients taking salmeterol in a recently completed large U.S. safety study Advair Label.
Update On May 16, 2006, The FDA announced that the product label for Advair has been updated with a warning that the drug might well increase the chance of severe asthma attacks that can result in death.
Side effects of Advair may consist of the following: bronchitis, cough, vomiting, diarrhea, difficulty speaking, fungal infection of the mouth, headaches, stomach pain, hoarseness, muscle and bone pain, nausea, sore throat and sinus pain.