Avandia Lawsuit Settled Case Loans

Avandia Lawsuit Funding

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What Is Avandia?

Studies have confirmed that the popular diabetic drug Avandia (a generic name is Rosiglitazone) has been linked to a number of serious and life-threatening cardiac risks and consequences. 

Avandia (Rosiglitazone) is a member of class of drugs called Thiazolidinediones, or TZDs.  It was approved by the FDA in 1999.  It was released by GlaxoSmithKline (GSK) for the treatment of Type-2 diabetes as either a stand-alone medication or in combination with Metformin (Avandamet) or with Glimepiride (Avandaryl).

The Controversy

In 2007, more than eight years after Rosiglitazone was first introduced onto the market, a study conducted by Dr. Steven Nissen at the Cleveland Clinic made public the serious heart risks associated with the drug’s use.  Dr. Nissen analyzed data that was handed over to the FDA in 2005.  The data suggested that taking Avandia significantly increased the risk of heart attacks and heart-related deaths by over 40% and 60%, respectively.  Dr. Nissen’s study was published in the New England Journal of Medicine (NEJM), a well-respected peer-reviewed medical journal.

Largely in response to this study, in 2007 the FDA reevaluated Avandia and confirmed Nissen’s findings. Nissen’s study further spurred a Senate Finance Committee investigation into the drug and its side effects. 

The two-year investigation culminated in a 342-page report that concluded there was sufficient evidence to suggest that GSK was aware of the association between the drug and its cardiac risks several years prior to Nissen’s study becoming public.  In fact, the evidence even suggested that GSK knew of the risks possibly as early as 1999, almost the same time the drug was approved by the FDA. 

The Senate’s report further argued that the company had a duty to sufficiently warn patients and the FDA of its concerns because the report indicates “GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (Pioglitazone) might reduce cardiovascular risk.”

Avandia Side Effects

In addition to the increased risks of heart attack, stroke, and other cardiac events, some of the more common side effects include upper respiratory infections (cold-like symptoms); headaches; weight gain; back pain; anemia (low red blood cell count); bone fractures, hypoglycemia (low blood sugar), with symptoms of nervousness, sweating, intense hunger, trembling, weakness, or palpitations. Here is the full list of side effects.

Numerous lawsuits are currently pending against GSK, the manufacturer, alleging that it knew about severe adverse side effects and failed to disclose them to the FDA and the general public. Potentially serious side effects can include:

The most significant side effect observed in clinical trials has been heart attacks and heart failures.

In studies involving over 14,000 patients, the results showed that users suffered 43% more heart attacks than those on a placebo.

Since its inception, the drug has been prescribed to millions of Americans and has generated as much as $3.2 billion per year in sales, as of 2006 and $1.19 billion as of 2009. Experts believe the drug is responsible for hundreds of thousands of cardiovascular problems in the U.S. from 1999 to 2009.

Is A Recall On The Horizon?

A public safety advisory was issued in 2007 to warn patients of the cardiovascular risks associated with the drug’s use. The FDA however, has refused to issue a recall, claiming that sufficient evidence as to the dangers versus the benefits of the drug does not exist.

Avandia Settlements

As of July 2010, GSK has set aside $460 million to settle lawsuits filed by some 10,000 patients (an average of over $40 thousand per plaintiff) and thousands of more injured patients are gearing up to sue GSK over the drug.