Advair Causing Deaths

On November 18, 2005, the U.S. Food and Drug Administration (FDA) alerted health care professionals and patients that the popular asthma medication, Advair, is associated with an increase of severe bronchospasms in those who take the medication and requested that its manufacturer, GlaxoSmithKline, update warnings in Advair?s product label. In March 2006, the FDA approved the pharmaceutical company?s new labels for Advair and Serevent (one of the two drugs that make up Advair). However, just a few months later the results of a joint study by Stanford University School of Medicine and Cornell University raised concern over whether the drugs may be causing an increase in deaths among their users. According to researchers, the reason is that although these medications relieve asthma symptoms, they also promote bronchial inflammation and sensitivity without warning. The study was published in the June 20, 2006 addition of the Annals of Internal Medicine.

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The results of the study suggest that salmeterol (the generic name for Serevent) and a similar asthma medication, formoterol (manufactured by the drug company Novartis) may be responsible for four out of five asthma-related deaths each year. The results of the study were based off of an analysis of nineteen published trials on the drugs. The study concluded that patients who inhaled salmeterol or formoterol more than tripled their risk of death from asthma-related complications, and were more than twice as likely to be hospitalized for asthma attacks compared to the participants who took a placebo. "These asthma deaths are generally in healthy young adults," said Stanford researcher and lead author of the study, Shelley Salpeter. "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.?

The largest of the nineteen trials surveyed in the study was the Salmeterol Multicenter Asthma Research Trial. Of the 26,000 patients who participated in the trial, the half who were given inhaled salmeterol to manage their asthma or chronic obstructive pulmonary disease (a condition for which Advair and Serevent are also prescribed) showed a four-fold increase in asthma-related deaths compared to the participants who were not treated with the drug. Salpeter also concluded that if the number of participants who received the drug for chronic obstructive pulmonary disease were removed from the analysis, salmeterol would be associated with a six-fold increase in the risk for asthma-related deaths.

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According to the study, adding an anti-inflammatory drug to salmeterol or formoterol does little to decrease the risk of death and other severities. Advair, for instance combines salmeterol with the bronchial anti-inflammatory drug, fluticasone. Nevertheless, twice as many patients inhaling such a combination of drugs required hospitalization compared with trial participants who took a placebo and an anti-inflammatory drug by itself.

The safety of serevent had been questioned since its approval by the FDA in the mid-1990?s. Within two years from its inception in the market, the FDA received reports of several deaths contributed to the drug. A letter to the New England Journal of Medicine described two elderly patients who had died while still clutching their Serevent inhalers. After adding warnings to Serevent?s label upon FDA recommendation, GlaxoSmithKline set up the salmeterol trial in 1996. The company aimed to track a total of 60,000 patients on Serevent for a number of years. In the meantime, however, the company brought Advair to the market in 2001 with much success, even though the drug contained salmeterol. Partially into the salmeterol trial (and having only acquired 26,000 participants) GlaxoSmithKline ended the trial after a larger number of participants who were given salmeterol died from asthma-related complications. In all, thirteen participants who were treated with salmeterol had died of asthma, while only three people had died after taking the placebo.

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Advair is the fourth best-selling drug in the world, with over $5.6 billion in annual sales and more than 62 million prescriptions dispensed for the drug since its introduction. Advair is also one of the most advertised drugs, with GlaxoSmithKline spending close to $200 million to market the medication each year. Despite the risks associated with Advair and Serevent, the FDA has urged patients not to quit taking the drugs or any asthma medication without first discussing it with their doctors. The FDA has also stressed that salmeterol is not a replacement for inhaled corticosteroids, and that those who use an asthma inhaler containing salmeterol should not reduce their dose of inhaled corticosteroids. Serevent and Advair should not be given to patients who are suffering from progressively worsening asthma and should not be used to treat acute symptoms of asthma.

If you or a family member has experienced severe side-effects while being treated with Advair or Serevent and would like to discuss your rights regarding your injury, please fill out this short form, and a member of Seeger Weiss?s experienced legal staff will contact you. Initial consultations with attorneys are free of charge and do not create an attorney-client relationship. Seeger Weiss, LLP is recognized as one of the most prestigious complex litigation and pharmaceutical litigation firms in the nation. Seeger Weiss, LLP maintains offices in both New York and New Jersey and its attorneys are available to practice throughout the country.