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Injured by Advair?
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 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.
If you or a loved one took Advair and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
AdvairRSS Feed
FDA Seeks Info on Serevent, Advair, Foradil As Part of Safety Review
Mar 6, 2008 | Parker Waichman Alonso LLP
Asthma drugs, including Serevent, Advair, Foradil, are the subject of a Food & Drug Administration (FDA) safety review. The FDA has requested information from the manufacturers of the asthma medications as part of an ongoing safety review of the drugs in children. Serevent, Advair and Foradil are long-acting beta 2-adrenergic agonists that prevent the release of substances in the body that cause inflammation of airways in the lungs. In 2005, the FDA...
Serevent and Advair May Cause Injury, Death in Children, FDA Report Says
Nov 26, 2007 | Parker Waichman Alonso LLP
Serevent and Advair, top-selling asthma drugs, will take center stage this week, when a Food & Drug Administration (FDA) panel meets to discuss the use of these medications in children. A report prepared by FDA staffers and posted on the agency's website indicate that both Serevent and Advair can have rare but deadly side-effects when used in children.Serevent and Advair, both manufactured by GlaxoSmithKline, are inhalation powders used to prevent asthma attacks. Asthma is...
Researchers Say "Killer" Asthma Inhalers Should Be Recalled
Jun 20, 2006 | Consumer Affairs
Researchers from Cornell and Stanford universities have concluded three common asthma inhalers containing the drugs salmeterol or formoterol may be causing four out of five U.S. asthma-related deaths per year and should be taken off the market. The researchers made their recommendation after concluding a search of medical literature. They base these conclusions on a statistical analysis of 19 published trials involving 33,826 patients. This so-called meta-analysis found that patients who...
Asthma inhalers causing deaths - study
Jun 20, 2006 | UPI
Three asthma inhalers with salmeterol or formoterol may cause 80 percent of U.S. asthma deaths annually, says a new study. Because of the possible health risks, these products sold as GlaxoSmithKline's Serevent and Advair, and Novartis' Foradil should be recalled, said researchers at Cornell University and Stanford University. "These asthma deaths are generally (occurring) in healthy young adults," said Stanford researcher Shelly Salpeter. "We estimate that approximately 4,000...
Common Asthma Inhalers Cause Up to 80% of Asthma-Related Deaths, Cornell and Stanford Researchers Assert
Jun 9, 2006 | www.docguide.com
Three common asthma inhalers containing the drugs salmeterol or formoterol may be causing four out of five U.S. asthma-related deaths per year and should be taken off the market, researchers from Cornell and Stanford universities have concluded after a search of medical literature. They base these conclusions on a statistical analysis of 19 published trials involving 33,826 patients. This so-called meta-analysis found that patients who inhaled the long-acting beta-agonists salmeterol (trade...
Advair
Advair FDA Information
FDA Drug Information Facts
ADVAIR (Salmeterol / Fluticasone) FDA INFORMATION
The FDA has issued several warnings concerning Advair related side effects. The links below will redirect you to these warnings on the FDA website.
Quick Facts
Advair Reference Guide
Generic Name
Fluticasone propionate
Salmeterol
Date Approved
August 25, 2000
Manufacturer
GlaxoSmithKline
Status
8/03 FDA label update
11/15/05 FDA warning
5/16/06 FDA new label update
Approved Uses
Asthma
Serious Side Effects
Asthma-related death
Bronchitis
Sore throat
Sinus pain
Related Topics
Foradil
Serevent
Asthma
Defective Drugs
Diseases
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