Glaxo’s Best-selling Asthma Drug May Be Unsafe For Some Users
In an April 6, 2006 article, Forbes reporter Robert Langreth addresses this issue: "Does the world’s bestselling asthma drug sometimes kill the patients it is supposed to help?"
Advair — made by GlaxoSmithkline and approved by the FDA in 2000 — had $5.6 billion in sales in 2005 based on 21.1 million U.S. prescriptions. In his Forbes article, Mr. Langreth reviews the mounting evidence which suggests that Advair may be causing asthma-related deaths in some patients who use it. According to one doctor interviewed for this Forbes story, as many as 4,000 deaths a year may be attributable to Advair, or the Serevent part of the Advair product.
"If we got these drugs off the market, we could prevent 4,000 deaths a year," argues Shelley Salpeter, a clinical professor of medicine at Stanford University who says both Advair and Serevent should be recalled. She pored over the results of 19 previous trials of Serevent-style drugs and found that patients have twice the rate of asthma hospitalizations, twice the rate of life-threatening asthma and four times as many deaths as patients who aren’t on those drugs. She believes Advair and Serevent cause four of every five asthma-related deaths each year. "These drugs make asthma worse," she says. By some estimates, asthma kills roughly 5,000 Americans a year.
In more detail, Advair is made up of two parts, namely Serevent, a "beta agonist", and Flovent, an inhaled steroid. Both Serevent and Flovent are available separately as asthma drugs, but their prescription numbers pale in comparison to Advair. As mentioned at the outset, 21.1 million Advair prescriptions were written by doctors in 2005 (due in part, you think, to the reported $137 million Glaxo spent in 2005 on Advair advertising?) compared to 3.5 million Flovent prescriptions and 1.7 million Serevent prescriptions.
This April 2006 Forbes article by Mr. Langreth does a good job of reviewing the safety-profiles of Advair, Serevent, and Flovent as each developed over time, including coverage of the earlier reports of asthma-related deaths that have been associated with Serevent.
In his article, Mr. Langreth also covers the affect of Glaxo’s extensive advertising to promote Advair:
"A large number of patients are being treated uselessly," says Fernando Martinez, professor of pediatrics at the University of Arizona. "We have to target these medicines to those that need them. What’s happening now is many patients get the combination straight away."
In July 2005 an FDA advisory panel voted in favor of keeping both Advair and Serevent on the market. Later, the FDA said that Serevent should not be used by itself. Then, in November 2005, the FDA issued a warning that Advair should be used by asthma patients only after other asthma drugs had failed to control their disease. Lastly, a new package insert, or label, for Advair was released by Glaxo in March 2006.
We will continue to monitor this emerging drug-safety issue regarding Advair and Serevent.
(Posted by: Tom Lamb)
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