Study Finds Increased Risk Of Serious Side Effects For A Broad Range Of Users
A study published in June 2006 by a leading medical journal concludes that GlaxoSmithKline’s popular asthma drug Advair is perhaps more dangerous to its users than previously thought. Further, the authors of this new study are so concerned about their findings that they have suggested that Advair possibly should be taken off the market.
The study, which was published in Annals of Internal Medicine, is essentially a new analysis of 19 previous studies concerning Advair and Serevent (another Glaxo asthma drug), as well as Foradil (made by Novartis) — asthma drugs which are long-acting beta-agonists, commonly referred to as LABA’s.
The study’s analysis revealed a significantly increased risk of serious side effects, including death, to users of Advair, Serevent, and Foradil when compared to people with asthma who used placebos. Moreover, the study’s authors found that the increased risks affected a broader range of Advair, Serevent, and Foradil users than had been previously thought.
According to a June 6, 2006 Washington Post article by Marc Kaufman, "the authors of this new study have estimated that Advair ‘may be responsible’ for as many as 4,000 of the 5,000 asthma-related deaths each year in the United States." In more detail, this Washington Post staff reporter writes:
"What we have here is a drug that increases the number of people who will die from the disease it is treating," said lead author Shelley Salpeter of Stanford University. "The long-acting bronchodilators can help reduce symptoms for many people, but we think the price in terms of serious side effects and deaths is unacceptable." . . .
"The use of long-acting [bronchodilators] could be associated with a clinically significant number of unnecessary hospitalizations, intensive care unit admissions and deaths each year," the authors wrote. "Black box warnings on the labeling for these agents clearly outline the increased risk for asthma-related deaths associated with their use, but these warnings have not changed prescribing practices of physicians."
More generally, according to Mr. Kaufman, Dr. Salpeter said "the results found that people on the long-acting medication were four to six times more likely to die of asthma-related causes than those on placebo."
This new study, however, raises especial concern about the safety of Glaxo’s Advair because of the fact that more than 3.5 million people in the U.S. used Advair last year, making it the nation’s fifth most sold drug — with $3.4 billion in sales for Glaxo — according to IMS Health.
Glaxo, predictably, disputed the findings of this new study in the Annals of Internal Medicine. According to the Post’s June 6 article, Glaxo spokeswoman Mary Anne Rhyne said: "The author’s conclusions are inconsistent with a large body of evidence and experience of patients."
Only last year Glaxo publicly disagreed with the FDA about the safety of Advair. After an advisory panel meeting convened to examine the reports of serious side effects associated with the LABA class of asthma drugs, the agency issued a public advisory in November 2005. Simultaneously, the FDA said that the "black-box" warning for Advair — originally put on the Advair label in 2003 Glaxo at the insistence of the FDA — should be strengthened. Like it did in 2003, Glaxo resisted the stronger warning desired by the FDA, and the drug company was able to delay any such change to the Advair label, or package insert, until March 2006.
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