Douglas C. Monsour Drug and Medical Device Litigation Law Blog on Lawyers.com

Avandia or Rosiglitazone, from GlaxoSmithKline, is a widely used FDA approved anti-diabetic drug in the thiazolidinedione class of drugs.  According to GlaxoSmithKline, the benefit of Avandia in conjunction with proper diet and exercise is improved blood sugar control for people with type 2 diabetes because the drug helps the body use its natural insulin better.  Source: http://www.avandia.com/new-to-avan dia/type-2-diabetes.html

Heart Attacks & Possible Side Effects from Avandia

As with many drugs, there are side effects, so it is not recommended that Avandia be taken with insulin or nitrates.  Source: http://www.avandia.com/new-to-avan dia/type-2-diabetes.html

In May 2007, the New England Journal of Medicine published a report suggesting that Avandia (rosiglitazone male ate) may significantly increase the risk of heart attack and heart-related death--especially in those who have a prior history of heart disease or who are considered at risk for a heart attack. Immediately following the report, the U.S. Food and Drug Administration issued a safety alert encouraging patients taking Avandia to consult with their doctor about possible treatment alternatives.

On August 15, 2007, the FDA announced that manufacturers of certain drugs approved to treat type 2 (non-insulin-dependent) diabetes have agreed to add the agency's strongest warning—"boxed"—on the risk of heart failure. This cardiovascular condition occurs when the heart does not adequately pump blood.

Which Drugs Will Receive the Warning?

The upgraded warning emphasizes that the following medications in the class of antidiabetic drugs (thiazolidinediones) may cause or worsen heart failure in certain patients:

• Avandia (rosiglitazone)

• Actos (pioglitazone)

• Avandaryl (rosiglitazone and glimepride)

• Avandamet (rosiglitazone and metformin)

• Duetact (pioglitazone and glimepride)

Click here to read more about the warning from the FDA: http://www.fda.gov/ForConsumers /ConsumerUpdates/ucm049060.htm

Then, on Nov. 14, 2007, the FDA announced that the manufacturer of Avandia (rosiglitazone), GlaxoSmithKline, had agreed to add new information about potential increased risk for heart attacks to the existing boxed warning. This action follows recommendations made at the July 2007 joint meeting between FDA's Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees.

GlaxoSmithKline's Response;

"In these clinical trials, which included patients with long-standing diabetes (average 12 to 13 years) and a high prevalence of pre-existing medical conditions (e.g., ischemic heart disease 14%, vascular disease 9%, congestive heart failure 2.5%), an increased incidence of cardiac failure and other cardiovascular adverse events was seen in patients receiving Avandia and insulin compared to insulin alone." Click here to read more…

Avandia Lawsuits & Litigation

GlaxoSmithKline has made billions of dollars from sales of Avandia, the most popular diabetes drug in the world. Although the drug has been extremely profitable for its maker, those profits have not been without a certain cost--a cost borne by patients who have suffered harm as a result of taking Avandia.

If you or someone you love has taken Avandia and suffered a heart attack or heart-related death, make sure your legal rights are protected by contacting an attorney experienced in Avandia pharmaceutical litigation. You may be entitled to compensation for your losses and suffering.