Avandia Litigation Attorneys
Avandia (rosiglitazone maleate) is an oral anti-diabetic agent manufactured by GlaxoSmithKline that helps lower blood sugar levels. It enables the body to manage Type 2 diabetes (or non-insulin dependent diabetes) by increasing insulin sensitivity. Avandia was approved by the Food and Drug Administration (FDA) on May 15, 1999, for treatment of Type 2 diabetes.
Type 2 diabetes is the most common form of diabetes and it affects millions of Americans. It is estimated that 20.4 million Americans have Type 2 diabetes, which is the leading cause of coronary disease, blindness, kidney failure and limb amputation.
Most Type 2 diabetics can control their blood-glucose levels and symptoms through diet and exercise and by taking oral medications prescribed by their physician.
So when GlaxoSmithKline introduced the diabetes drug Avandia in 1999, it quickly became the best-selling oral diabetes treatment in the world. By 2006, sales of Avandia had reached $3.4 billion, and it was being taken by an estimated 6 million Americans.
Unfortunately, in 2007, new and troubling questions arose about Avandia’s side effects.
In October 2007, the United States Department of Veterans Affairs (VA) announced that it was dropping Avandia from its prescription drug formulary. In announcing the move, the VA said that it had conducted its own review and concluded that, for some patients, Avandia did not afford the same margin of safety as other diabetes medications.
In November 2007, the American Diabetes Association called on doctors to use more caution when prescribing oral medications to treat patients with Type 2 diabetes.
Early in 2008, a Wisconsin woman filed the first Avandia lawsuit in the U.S. District Court of the Southern District of Illinois, seeking damages for personal injuries and economic losses as a result of using Avandia.
She alleged that GlaxoSmithKline failed to conduct sufficient testing and misrepresented information concerning the safety and efficacy of Avandia for treating diabetes. Since then, more than a hundred other individuals have filed Avandia lawsuits against GlaxoSmithKline.
On Oct. 31, 2008, a watchdog group, Public Citizen, representing more than 80,000 consumers nationwide, called on the FDA to immediately ban Avandia. The petition cited the drug’s multiple serious risks, including 14 cases of liver failure, of which 12 were fatal.
In addition, Public Citizen cited evidence of increased risk of heart attacks, heart failure, bone fractures, anemia and macular (retinal) edema with vision loss, and a lack of evidence of any clinical benefit, compared to other approved drugs for diabetes.
By November 2008 the FDA announced the addition of a new black box warning for Avandia’s increased risk of heart attacks. Among the risks cited by the FDA, the most serious was heart failure.
In February 2007, GlaxoSmithKline Kline issued a press release noting that there was a greater incidence of fractures of the upper arms, hands and feet in female diabetics taking Avandia than those given other drugs.
The following May, an article in The New England Journal of Medicine reported that the use of Avandia was associated with an increased risk of heart attack and an even higher risk of death from all cardiovascular diseases. The authors estimated that users of Avandia faced a 43% higher risk of heart attack or other cardiovascular events.
May 2007, the FDA issued an advisory or safety alert for Avandia.