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Avandia Linked to Heart Attacks FAQ

What is Avandia?

Avandia (known generically as rosiglitazone maleate) is a drug that was developed to treat type 2 diabetes mellitus. It is manufactured by GlaxoSmithKline and was first approved by the US Food and Drug Administration (FDA) in 1999. Avandia reduces the patient's insulin resistance and helps the patient's body use the insulin it produces.

Why are there Avandia lawsuits?

Lawsuits have been filed alleging that Avandia causes an increased risk of heart attack and stroke. Furthermore, the lawsuits allege GlaxoSmithKline knew about that increased risk but did not adequately warn patients and physicians.

What are Avandia side effects?

Avandia has been linked to an increased risk of heart attack and stroke, bone fracture, and macular oedema. Other side effects include weight gain, cold, cough, headache, sinus inflammation, fluid retention and cardiac arrest.

Has there been an Avandia recall?

No, Avandia has not been recalled. It is currently sold with a black box warning alerting patients to the risk of heart attacks.

What does the FDA say about Avandia?

In July 2010, the FDA convened an advisory committee to discuss Avandia's risks and vote on whether or not to keep Avandia on the market. [An advisory committee is a committee of experts who make recommendations to the FDA concerning medications. Although the committee makes recommendations, those recommendations are not binding, meaning the FDA can take action contrary to what the advisory committee recommends.]

According to The New York Times, (07/14/10), 12 members of the 33-member advisory committee voted to withdraw Avandia from the market, 10 members voted to allow it to remain on the market but with serious changes to the label, 7 members voted to add further warnings to the Avandia label, 3 members voted to allow Avandia to be sold as is and 1 member abstained in the vote.

The US FDA has not announced what action it will take concerning the sale of Avandia.

Also in July 2010, the FDA ordered GlaxoSmithKline to stop enrolling patients in a trial that compared the safety of Avandia with the safety of rival drug Actos. Patients already enrolled in the study can remain in it if they wish (see below for more information).

What should I do if I take Avandia and am concerned about side effects?

If you take Avandia and are concerned about the side effects, speak with your physician about your options. Do not stop taking Avandia without consulting your doctor.

What about the Avandia studies--what were the results?

A 2007 study of Avandia, published in New England Journal of Medicine found that patients who took Avandia had a 43 percent higher risk of heart attack than patients who took a different diabetes medication or took no medication at all.

According to an FDA news release (11/14/07), a meta-analysis of 42 studies found Avandia to be associated with an increased risk of myocardial ischemic events compared with a placebo.

Where does Avandia litigation stand?

There is currently on-going litigation regarding Avandia. The 7/15/10 edition of The New York Times reports that GlaxoSmithKline agreed to settle approximately 10,000 Avandia lawsuits for a total of $460 million. Other lawsuits are currently pending. If you think you might have an Avandia lawsuit claim, you should contact an Avandia lawyer.

What is the news about the TIDE trial?

The FDA has ordered GlaxoSmithKline to stop enrolling patients in a safety study known as the TIDE (Thiazolidinedione Intervention in Vitamin D Evaluation) trial. Patients who are currently enrolled in the study can decide for themselves if they wish to remain involved. The study was designed to compare the safety of Avandia with the safety of rival drug Actos. Critics of the study, however, argued that the trial was "unethical and exploitative" because it put patients at unnecessary risk of serious side effects. GlaxoSmithKline defended the trial, saying it was ethically conducted.

According to FDA (07/21/10), a decision will be made regarding the TIDE trial when a review of the advisory committee's discussions and recommendations is complete.
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Last updated on Jul-1-10

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