The Chronicles of Avandia®: Heart Disease Warnings in May of 2007, and thereafter

Avandia® has been on the market since 1999, and it has been a hugely popular diabetic drug, controlling blood sugar by the increase of insulin sensitivity. Usually used in tandem with other diabetes drugs, Avandia® was heavily marketed and netted $3.4 billion for manufacturer GlaxoSmithKLine in 2006.

Then came an article published in the New England Journal of Medicine in May of 2007, estimating that Avandia® users faced a 43 percent higher risk of heart attack or cardiovascular event. The article made a huge impression. GlaxoSmithKLine disputed the findings, which were also the subject of much internal dispute within the FDA.

The Food and Drug Administration convened a special meeting to monitor Avandia’s safety risks on July 30, 2007 in Gaithersburg, Md. The finding of the panel was to leave the drug on the market, and on November 14, 2007 a boxed warning was added to Avandia®. The press release says, “Agency says drug to remain on market while safety assessment continues”.

Patients with diabetes already have increased potential for heart disease; it’s a known result of the condition. The American Diabetes Association says that 2 out of 3 people with diabetes die from heart disease and stroke. If you were prescribed Avandia you have been potentially subjected to even higher risks of heart disease.

If you or a loved one have taken Avandia® and have experienced heart attacks or heart disease, or a significant worsening of an already existing cardiac condition, or if someone you know has died as a result of taking Avandia®, contact Eric Gruenwald, Attorney / Lawyer at (866) 529-0001, EXT. 245 or by email at help@mulliganlaw.com The consultation is free of charge.

Excerpts from the November 14 Warning:

FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia
Agency says drug to remain on market, while safety assessment continues
The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug’s labeling about potential increased risk for heart attacks.

The revision of Avandia’s existing boxed warning – FDA’s strongest form of warning – includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.
GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia…

Today’s action follows recommendations made at the July 2007 joint meeting of FDA’s Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.

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