Lawsuit Over Type 2 Diabetic Drug Avandia- Get the Facts

UK-based pharmaceutical drug manufacturer GlaxoSmithKline (GSK) is currently facing a New York filed class action lawsuit over their drug Avandia, a Type 2 diabetes medicine approved by the FDA in 1999. The drug has been branded as a possible trigger of heart attacks in diabetic patients. The lawsuit alleges that GSK did not exercise due diligence in disclosing the drug's potential side effects.

According to Avandia's web page, maintained by GSK, Avandia works differently than other diabetes medicines in that it does not cause the body to produce more insulin, but rather promotes improved blood sugar control by the efficient use of the body's own natural insulin.

Type 2 diabetes is the most common form of diabetes, affecting approximately 18 million Americans. In Type 2 diabetes, the body does not respond properly to or is unable to produce insulin, a hormone that causes cells to absorb the energy-producing carbohydrate glucose from the blood. When this happens, sugars build up in the blood, leading to other complications. Citing GSK's clinical trials, Avandia asserts it is the most studied medicine for Type 2 diabetes. Since 2002, nearly 5 million people with Type 2 diabetes have used Avandia.

Avandia is GSK's second best seller, after its asthma drug Advair. At the time the FDA approved Avandia, pharmaceutical giant Pfizer was having problems marketing its own diabetic drug, Rezulin. Avandia hit the ground running and generated billions in sales, especially after Rezulin was removed in 2000 because of the drug's link to liver problems.

The New England Journal of Medicine (NEJM), in May of 2007, first published a possible link between the anti-diabetic drug Rosiglitazone, the active ingredient in Avandia, and a significant increase in the risk of myocardial infraction (heart attack) and an increase in the risk of death from other cardiovascular causes. The study reported a 40% escalation in the risk of heart attack among patients who received Rosiglitazone as compared with those who received an alternative oral diabetes therapyor a placebo.

Thereafter, the Food and Drug Administration issued an alert for immediate release regarding the safety issues relating to Avandia, citing a "potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia." Although the report indicated they could not confirm the clinical significance of the risk increase, the FDA did release a heightened warning to the product's labeling which advised of a potential increase in heart attacks and heart-related difficulties in individuals taking Avandia. Personal injury and wrongful death lawsuits began to be filed that same year.

Rosiglitazone has also been associated with bone fractures, particularly in women, as well as pulmonary edema or pleural effusion (fluid accumulation in the lungs or the area surrounding the lungs), anemia, weight gain, fatigue, irregular heartbeat, jaundice, nausea and abdominal pain. In some cases, the drug has been reported to worsen the existing side effects of diabetes. Macular edema, or a swelling of the eye due to fluid buildup, and blood sugar levels that are either elevated or bottomed out have also been described as prospective side effects.

This is not the first time a claim has been made that GSK withheld information about the dangers of one of their drugs. In 2006, GSK settled a 49 state lawsuit that claimed the drug maker wrongfully delayed generic competition for its depression drug Paxil. The lawsuit also alleged that the company withheld negative information suggesting a possible increased risk in suicidal thinking among individuals taking Paxil, especially in children. Part of that $14 million settlement required that GSK set up a website that would detail the drug maker's studies and latent risk findings. That same site was used by the NEJM when they conducted their 2007 study on Avandia.

In reply to the lawsuit, GSK has maintained that Avandia is no less safe than any other drug currently prescribed for the treatment of Type 2 diabetes, and that the FDA did not initially insist on any stronger Avandia warning. They also dispute the findings of the NEJM, citing their own long-term clinical trials that they say contradict those of the NEJM.

Any current or former user of the drug Avandia who believes they may be eligible for participation in the Avandia class action litigation should seek out the advice of an experienced attorney who is familiar in the prosecution of class action lawsuits.