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With over 62 million prescriptions since its introduction, and over $5.6 billion in annual sales, Advair, a popular asthma medication, was the fourth best-selling drug in the world. GlaxoSmithKline, the drug's manufacturer, spent nearly $200 million to market Advair each year.
But then in November 2005, the U.S. Food and Drug Administration (FDA) issued an alert warning health care professionals and patients that Advair is connected to an increase of severe bronchospasms (wheezing). The FDA additionally requested that GlaxoSmithKline, update the warnings on Advair's product label.
And, only a few months after the FDA approved the new labels for Advair and Serevent (which along with fluticasone makes up Advair), the results of a joint study by Cornell University and the Stanford University School of Medicine raised concerns over whether Advair may be causing an increase in death among its users.
The study, which was 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 and formoterol, a similar asthma medication manufactured by Novartis, may more than triple the risk of death from asthma-related complications to patients who inhaled these medications. The study also found that adding an anti-inflammatory drug (like fluticasone) does little to decrease the risk of severe complications or death.
In May 2006, the FDA issued an updated heath advisory taking the findings of the study into account. In addition to requesting that the manufacturers of Advair Diskus, Serevent Diskus, and Foradil Aerolizer update these products' labels to warn of their potential for causing severe asthma episodes and death, the advisory recommends using these medications only when others fail to control a patient's symptoms.
GlaxoSmithKline has since shifted its sales force strategy for Advair to stress its treatment for chronic obstructive pulmonary disease (COPD), a use for which the FDA gave the drug its approval in 2003. In fact, about 42% of the sales of Advair were already for use in treating COPD in 2005. There is currently at least one trial intended to study the effects of Advair in outpatients with COPD with acute exacerbation. But, in addition to the adverse effects of Advair for use in treating asthma, the following are already known additional potential side effects of the drug:
- Sore throat
- Difficulty speaking
- Fungal infection of the mouth
- Stomach pain
- Bone and muscle pain
- Sinus pain
If you or a loved is suffering any of the side effects described in this article after taking Advair, regardless of the condition for which it was taken, you may wish to consult with an experienced pharmaceutical injury attorney. You or your loved one may be entitled to compensation for any injuries suffered as a result of taking Advair.