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Serevent and Advair, which combines Serevent with a steroid, had worldwide sales of $4.4 billion last year.

Advair FDA Warning

The FDA issued a Public Health Advisory on Nov. 18, 2005 , stating that Advair, Serevent and Foradil should not be used as a first-line treatment against asthma but only after other medications have failed to work. The FDA public health advisory warns about potentially fatal side effects from two GlaxoSmithKline asthma drugs. (It also urged patients NOT to stop using the medicines without first consulting their doctors.)

Advair, Serevent and Foradil belong to a class of medicines known as long-acting beta agonists, or LABAs, which are long-acting bronchodilator drugs. While these asthma medicines work to reduce the frequency of asthma attacks, the attacks can be worse when they do occur among patients using LABAs.

Advair Quick Facts

Advair was approved in 2000, by the FDA and is made by GlaxoSmithKline.

FDA says Advair "may increase the chances of a severe asthma episode when they do occur."

One major study found 13 deaths among 13,174 patents using Serevent while there were only four deaths among a similar number of patients given a placebo – or more than triple the number of deaths.

Serevent and Advair, which combines Serevent with a steroid, had worldwide sales of $4.4 billion last year, making the medicine the biggest-selling product for the London-based Glaxo. Foradil had 2004 sales of about $320 million.

About 15 million Americans have asthma, nearly one-third of them children. The chronic lung disease causes inflamation in the airways of the lungs and constriction of nearby muscles.

Advair History

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 Side Effects

Side effects of Advair could contain the following: bronchitis, cough, vomiting, diarrhea, trouble speaking, fungal infection of the mouth, headaches, stomach ache, hoarseness, muscle and bone pain, queasiness, sore throat and sinus pain.