Drug Warning: Advair
Mixture of: fluticasone and salmeterol (more commonly known as serevent)
Manufactured and marketed by: GlaxoSmithKline
Purpose: Helps shrink the swelling in the airways and relax and open air passages in the lungs in order to treat asthma.
Side Effects Reported
- Side effects include 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.
- Advair may also exacerbate asthma symptoms in certain patients, and may be linked to several deaths.
Industry Report
A black box warning, the strongest type of drug warning, was added to Advair labels in 2003, based on preliminary results of the Salmeterol (Serevent) Multicenter Asthma Research Trial. GlaxoSmithKine also issued a "Dear Healthcare Professional" in which it described the interim findings but said they were "inconclusive" as the deaths and serious adverse events reported could neither be attributed to use of Serevent, nor could Serevent be excluded as a cause.
An interim analysis revealed an increased risk of asthma-related deaths and life threatening episodes among patients given the drug (13 deaths out of 13,176 patients treated for 28 weeks versus 3 of 13,179 for those on placebo). The FDA says that further analysis of the data suggest that the risk might be greater in African-Americans.
Seeger Weiss is not currently pursuing lawsuits on this drug, but its drug warnings will remain on our radar.
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