Serevent Side Effects Lawsuit News

Asthma Treatments - Common Asthma Inhalers Can Cause Death with Repeated Use

06/19/2006 - Researchers from Stanford and Cornell Universities are recommending three asthma inhalers be pulled from the U.S. market. Four out of five U.S. asthma-related deaths per year may be caused by inhalers containing the drugs salmeterol or formoterol. 

The researchers base their conclusions on 19 published studies involving 33,826 patients.  There statistical analysis found that the patients who inhaled the long-acting beta-agonists salmeterol or formoterol  were 3.5 times more likely to die from asthma and 2.5 times more likely to be hospitalized.

Salmeterol is made by GlaxoSmithKline under the brand-names Serevent and Advair.  Foradil (brand name for Formoterol) is manufactured by Novartis Pharmaceuticals.  All three inhalers relieve asthma symptoms, but they also promote bronchial inflammation and sensitivity without warning.  The researchers admit the risk of death is relatively low, but 15 patients in the meta-analysis who were taking the beta-agonists died, compared with three in the placebo group, over a six-month period.

The meta-analysis of the studies has led the researchers to believe risk is high enough to remove the inhalers from the market.  Edwin Salpeter said “In total, there are about 5,000 deaths a year due to asthma, whether or not a person is taking a long-acting beta-agonist."  Salpeter is the J.G. White Distinguished Professor of Physical Sciences Emeritus at Cornell, who led the statistical analysis in the study.

An eminent astrophysicist, Salpeter has more recently focused his attention on medical statistics.  He says "We can show that overall it is statistically significant that, compared to patients taking a placebo, these long-acting beta-agonists kill a lot of people."

His daughter, Shelley Salpeter, says “These asthma deaths are generally in healthy young adults."  She is a clinical professor of medicine at Stanford's School of Medicine and a physician at Santa Clara Valley Medical Center in San Jose, California, and is lead author of the paper appearing online and in the June 20 issue of Annals of Internal Medicine.

Shelley said "We estimate that approximately 4,000 out of the 5,000 asthma deaths that occur in the U.S. each year are actually caused by these long-acting beta-agonists, and we urge that these agents be taken off the market."

Adding an anti-inflammatory drug to a long-acting beta-agonist adds little benefit, according to the Salpeters. Advair, for example, (the fourth bestselling drug in the world with $5.6 billion in annual sales), combines salmeterol with an anti-inflammatory drug to provide some protection against bronchial inflammation associated with beta-agonists. But hospitalizations still doubled for patients inhaling a long-acting beta-agonist combined with an anti-inflammatory drug compared with asthma patients taking a placebo and an anti-inflammatory drug by itself.

Users of the drugs can develop a tolerance to the drugs, and according to Shelley, these two long-acting beta-agonists can result in death. "These agents can improve symptoms through bronchodilation at the same time as increasing underlying inflammation and bronchial hyper-responsiveness, thus worsening asthma control without any warning of increased symptoms."

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