Attention Advair Diskus Inhaler Users

The Advair Diskus inhaler is manufactured by GlaxoSmithKline and was approved by the FDA in 2000. It 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.

In one study the FDA said, "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.

New label Warning

Increased risk of life-threatening asthma episodes or asthma-related deaths

In November 2005, the FDA 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 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. The FDA states that although they can reduce the number of asthma episodes, they "may increase the chances of a severe asthma episode when they do occur."

If you have taken Advair and have suffered any of these problems, contact us today!

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