Avandia recall should be considered according to researchers

Austin Kirk

By Austin Kirk
Posted September 12, 2007

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Two studies and an editorial published yesterday in the Journal of the American Medical Association (JAMA), provide compelling evidence which researchers indicate may warrant an Avandia recall.  One study confirmed earlier findings that Avandia increases the risk of heart attacks, while a second study found that Actos, an alternative drug for treatment of type 2 diabetes,  may actually reduces the risk of heart attacks, strokes and death.

>>INFORMATION:  Avandia Heart Side Effects

Avandia was a worldwide blockbuster diabetes drug, with sales of $3.35 billion throughout the world in 2006.  In May 2007, a report published in the New England Journal of Medicine, which reviewed data from prior clinical trials, found that the use of Avandia increases the risk of heart attacks and heart related deaths.  Since that information was released, sales have fallen sharply and the FDA convened an advisory panel in July 2007 to review the drug’s safety.

Although the FDA advisory panel did not recommend an Avandia recall, many doctors have already taken the issue into their own hands by switching their patients off of the medication.  Prior to May 2007, Avandia and Actos had near equal shares of the market for type 2 diabetes drugs.  By July 2007, Avandia’s market share only accounted for 33% and use of Actos had increased to 67%.  Researchers indicate that the findings published yesterday provide further justification for doctors to switch their patients from Avandia to Actos.

Researchers from Wake Forest University School of Medicine reviewed four clinical trials of Avandia which lasted at least one year.  After evaluating data from over 14,000 patients, the researchers found that those taking Avandia had a 42% increase in the risk of a heart attack and over twice the risk of heart failure, when compared with the control group.  These findings confirm the results of the earlier study published in May 2007 in the New England Journal of Medicine, which involved short term trials.

Although the research does not directly compare Avandia to Actos, another study published in the same issue provides a sharp contrast.  The Actos study involved a review of data from 19 clinical trials performed by researchers from the Cleveland Clinic.  When compared to a control group, those taking Actos were found to be 18% less likely to suffer a heart attack, stroke or death from any cause.

AVANDIA RECALL

Dr. Sonal Singh, the lead researcher from Wake Forest University, called for an urgent review by the FDA to determine whether an Avandia recall is necessary to protect consumers.  He indicates that one additional person out of every 30 individuals taking Avandia will suffer heart failure and one out of every 220 will suffer a heart attack due to the diabetes drug.

Proponents of an Avandia recall also point out that older drugs, such as Metformin, are available for treatment of type 2 diabetes and they may be preferable to either Actos or Avandia unless they lose their effectiveness over time.  Metformin is available as a generic, which cost approximately 20 cents a day, compared with over $2.00 per day for Avandia.

Once again, Glaxo continues to try to defend their drug and reduce the anticipated further loss of sales.  They allege that the data from these studies is not robust enough and that doctors should keep their patients on Avandia, potentially exposing them to life-threatening heart attacks, while larger scale research continues.  Understandably, many diabetes patients and doctors are not willing to accept the potential risk when Avandia carries minimal, if any, benefits over Actos and other treatments.

AVANDIA LAWSUITS

The lawyers at Saiontz & Kirk, P.A. represent individuals who are pursuing Avandia lawsuits as a result of a heart attack, stroke, heart failure or death which was caused by the medication.  Some experts have estimated that over 100,000 heart attacks could have been prevented if GlaxoKlineSmith had warned about the increased risk of heart problems associated with their drugs.

If you, a friend or family member believe an injury may have been caused by the diabetes drug, request a free Avandia lawsuit evaluation.

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