Avandia

Sweetland et al v. GlaxoSmithKline Inc.

Nova Scotia Supreme Court File: Hfx No. 315567

Avandia is an oral diabetes medication and is manufactured by GlaxoSmithKline. Since its introduction in 1999 more than 6 million people have taken Avandia or Avandamet.

Avandia is used in the prevention of Type 2 diabetes in high-risk patients who are not controlled by diet and exercise alone, to reduce insulin resistance and to lower elevated blood glucose in patients. This class of drug is known as thiazolidinediones (TZDs) or glitazones. Avandia (Rosiglitazone) is a TZD and was approved for dispensing in Canada on March 30, 2000.

Drugs of this class can cause fluid retention that may progress to congestive heart failure. In addition to cardiovascular issues, other symptoms include swelling (edema), shortness of breath, weakness, fatigue, or excessive weight gain.

An Advisory was posted by Health Canada in November of 2001 indicating that there were safety concerns associated with the use of this class of drug. More recently new concerns have been raised about the link between Avandia and the risk of heart attack. More than one million prescriptions for Avandia were filled in Canada in 2006, ranking it the third most popular oral diabetes drug.

A study published in the New England Journal of Medicine in May, 2007 showed that the use of Avandia caused a significant increase in the risk of heart attack and possible death. The NEJM analysis of 42 studies revealed that there was a 43 per cent higher risk of heart attack for those taking Rosiglitazone compared to people taking other diabetes drugs or no diabetes medication at all. The report further stated that there is a 64 percent increase in the risk of death due to cardiovascular issues as a result of ingesting the drug. Dr. Steven Nissen, a cardiologist with the Cleveland Clinic, estimates that tens of thousands of deaths are attributable to Avandia.

On June 1, 2007, in response to the NEJM article, Health Canada issued a new warning. Physicians were advised about the use of Avandia in combination with other drugs. Health Canada also made recommendations for the handling of patients and indicated there was a need by the physician to weigh the overall benefits of prescribing Avandia to their patients.

On June 6, 2007, the United States Food & Drug Administration announced it was calling for a black box warning on Avandia based on data that the diabetes drug is associated with an elevated risk of cardiovascular problems.

A further study published in the September 12 issue of the Journal of the American Medical Association indicated that one in 30 patients taking Avandia over the course of a year had heart failure and one in 220 had a heart attack.

Data obtained from Health Canada by the Winnipeg Free Press through an Access to Information request shows that 57 Canadians reported serious side-effects while taking Avandia and that 33 Canadians suffered heart failure, heart attack or stroke, and at least four people died.

Health officials were aware of heart risks linked to GlaxoSmithKline's widely prescribed diabetes drug Avandia for a number of years. In 2002, for example, the FDA requested reports of congestive heart failure to be included on the label of Avandia.

GlaxoSmithKline has known of the cardiovascular risks of Avandia for an extended period of time. In August 2006, the company conducted a similar analysis of clinical trials and estimated the heart risk increased by 31 percent among Avandia patients.

GlaxoSmithKline continues to tout the safety of their product despite these finding and disclosures.

Recently there has been further controversy concerning GlaxoSmithKline and Avandia as a report surfaced that a medical expert, John Buse, M.D., was threatened with a lawsuit by GlaxoSmithKline's executives when he initially raised doubts about the drug as far back as 1999.

Patients taking Avandia are encouraged not to stop taking Avandia without first consulting with their physicians.

Several lawsuits have been launched in Canada and the United States over the medication's adverse effects, and drug safety regulators in both countries have been investigating its safety.

Wagners Law Firm have filed a Notice of Action and Statement of Claim with respect to the adverse effects caused by the prescription drug Avandia. 

The following documents concerning the class action which Wagners has filed as a result of the serious and adverse side effects associated with the use of the diabetes medication Avandia are also available for viewing in PDF format:

Wagners is presently accepting enquiries from residents of Canada who have suffered serious cardiovascular problems associated with the use of Avandia.

If you, or a member of your family, have suffered congestive heart failure or other cardiac effects as a result of taking Avandia and injury, death or other losses have resulted, you may be eligible for inclusion as a Class Member in our proposed class action lawsuit.

To sign up and determine if you qualify, please fill out this registration form: