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Advair

An FDA advisory committee met in July 2005 to decide if Advair should remain on the market. Advair is the brand name drug combining fluticasone and salmeterol to prevent wheezing, shortness of breath and breathing difficulties caused by asthma. Made by GlaxoSmithKline, Advair contains the same drug - salmeterol - that is found alone in another Glaxo asthma drug called Serevent. Concerns have risen regarding the use of Advair because the FDA said a small number of patients have had severe asthma exacerbations.

Fluticasone is in a class of medications called steroids and is supposed to reduce swelling in the airways. The salmeterol is in a class of medications called long-acting beta-agonists and is supposed to relax and open air passages in the lungs, making it easier to breathe.

In a large clinical study, the use of Advair was found to cause a small increase in deaths from asthma in patients who used salmeterol. If patients have asthma that is quickly getting worse, the use of the drug combination should be avoided. Advair is inhaled to keep the airways open to prevent asthma attacks, not to cure it.

A black-box warning, the FDA's strongest issued drug warning, was added to Advair labels in 2003, based on preliminary results of the Salmeterol Multicenter Asthma Research Trial. The Advair warning labels were issued after the post-marketing study of Serevent study showed a small number of patients experienced severe exacerbations of their asthma, and it suggested African-Americans were particularly at risk.

The number of deaths in Advair patients was considered small but significant, revealing people who added the drugs to their usual treatment suffered 13 deaths in 13,176 patients versus 3 in 13,179 who took placebos. In November 2004, FDA whistleblower Dr. David Graham singled out Serevent as one of five drugs that may be linked to serious safety concerns when testifying about what he called the FDA's inability to protect the public from unsafe drugs.

The FDA asked its advisory panel to review the safety of Advair, as well as Serevent and Novartis' asthma drug Foradil. The committee of 14 asthma experts convened on July 13, 2005 and reviewed the data on the drugs, listened to presentations from the manufacturers and others.

While the FDA does not have to listen to its advisory committee's recommendations, the agency usually does. After meeting, the panel unanimously recommended the three drugs, including Advair, remain on the market, but the committee urged more research to determine whether the medications might actually worsen asthma in certain patients.

In 2004, Advair's U.S. sales reached $2.4 billion, and its worldwide sales of more than $4.5 billion made it the third best selling drug in the world. From July 2004 to July 2005, 17.2 million Advair prescriptions were filled. More than 21 million adults and eight million children in the U.S. have asthma.

For more information on Advair warning contact a Advair lawyer today!


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