Drugs in Class Action Litigation: Avandia

Generic name: rosiglitazone maleate

Manufactured and marketed by: GlaxoSmithKline

Purpose: To treat patients suffering from type 2 diabetes, also referred to as adult onset diabetes.

Side Effects Reported

  • Patients taking the diabetes drug Avandia were found to be at increased risk for a heart attack or heart-related death.
  • Avandia may cause heart failure, edema, low blood sugar, weight gain, low red blood cell count, abnormal ovulation, and liver problems.
  • Other common side effects include cold-like-symptoms and headaches.

Industry Report

As of August 2010, the Food and Drug Administration is deciding whether Avandia’s label must include new warnings; whether sales of drug will be restricted, or whether drug should be withdrawn from the market.

On May 21, 2007, researchers from the Cleveland Clinic published a study in the New England Journal of Medicine indicating that patients taking the diabetes drug Avandia were found to be at increased risk for a heart attack or heart-related death. The study has produced lawsuits for serious personal injury and wrongful death. For example, the family of a nurse who required three bypass operations and finally died of a stroke, filed suit against Glaxo. The family claimed that Glaxo had information about the dangers of Avandia that it withheld.

One of the primary issues in Avandia litigation is whether the manufacturer, Glaxo, responsibly reported all the dangers of Avandia to the FDA and to the public. A few U.S. legislators have already raised concerns about Glaxo’s honesty in this area. Glaxo has a bad record on safety reporting; it settled a lawsuit filed by then New York Attorney General, Eliot Spitzer, in which Spitzer charged Glaxo with fraudulently withholding results about the safety of prescribing the antidepressant Paxil to children.

On June 3, 2010, GlaxoSmithKline reportedly settled a class action lawsuit filed against them by plaintiffs who allege that their use of Avandia diabetes drug resulted in heart attacks or the death of loved ones.Terms of the settlement remain confidential, and it is not known how many plaintiffs were included.

Glaxo are maintaining that they gave ample warning to doctors and their patients pertaining to possible heart risks associated with the diabetes drug, but their claims are falling on deaf ears. Avandia is still on the market as a diabetes drug, but its sales are on the decrease as people fear the side effects associated with it.

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