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Avandia’s Safety Still in Question? Not According to Glaxo

It seems like the general public is the only group that fully understands the dangers the Type 2 diabetes drug, Avandia, presents to those taking it. For years now, we have been reading about the significant increase in cardiac events in diabetics taking the drug versus those taking a placebo or no drug at all. Why is this drug still on the market? Why are doctors still prescribing Avandia? Is the FDA really protecting consumers or protecting the drug companies’ wallets?

The safety of Avandia (generic rosiglitazone) has been in question since 1999 when Dr. John Buse of the University of North Carolina at Chapel Hill, a diabetes expert, performed a study in which he concluded that Avandia users experienced a “more than fourfold rise in cholesterol compared with those taking a placebo. Because elevated cholesterol levels are a risk factor for heart disease…Avandia could cause adverse cardiac outcomes.” When the maker of Avandia, GlaxoSmithKline, received a copy of this report, reps called Dr. Buse’s boss, accused him of lying and stated he needed to be “muzzled.” GSK then threatened to sue for $4 billion, which was the loss of the company’s valuation. After receiving Dr. Buse’s compelling evidence that Avandia did, indeed, increase cardiac events in users of the drug, GSK continued marketing the drug and even went so far as to find a doctor who reported that the drug actually reduced cardiovascular risk factors in laboratory animals.

By 2004, Avandia was making over $1.5 billion a year for Glaxo in the United States alone. In May of 2006, GSK provided the FDA with research indicating that Avandia use did cause a jump in adverse cardiac events, but the FDA did not release this information to the public. Why? Dr. Janet Woodcock, head of the FDA Center for Drug Evaluation and Research, “didn’t necessarily agree with some of the methodology used.”

Three years later, in May of 2007, Cleveland Clinic cardiologist, Dr. Steven Nissan analyzed 42 Avandia trials and submitted a report to the New England Journal of Medicine that there was a 43% higher rate of cardiac events among Avandia patients compared with those taking other drugs or placebos. It is now August 2010, and Avandia is still on the market and still being prescribed to millions of people who may not know how dangerous this drug is. GSK continues to insist its diabetes drug is safe and effective, and in July 2010, the FDA advisory group voted to not pull Avandia off the market, citing lack of strong evidence that it should be taken off the market.

Statistics regarding Avandia and cardiac events and death are not exact for several reasons, but Dr. David Graham, the lead author of the study that prompted the FDA to hold the hearing regarding the safety of the drug, asserts that 100,000 heart attacks, strokes, cases of heart failure, and deaths have occurred due to Avandia since it came on the market in 1999. How many more people have to suffer before the FDA recalls this drug?

If you or a loved one has taken Avandia and suffered any adverse side effect, please contact the experienced pharmaceutical liability attorneys at Schlichter, Bogard & Denton. We are currently taking Avandia cases and would like to help you if you have been harmed by this very dangerous drug.

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