Avandia® (Overview)

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Avandia, generically known as rosiglitazone, is a prescription medication used in the treatment of Type 2 diabetes. The medication is manufactured by pharmaceutical giant GlaxoSmithKline and received approval for release from the US Food and Drug Administration (FDA) in 1999. The medication is marketed alone under the brand name Avandia and is marketed as a combination with additional medications as Avandryl and Avandamet. Sales of Avandia totaled nearly $3 billion worldwide in 2006.

Type 2 diabetes, also known as adult-onset diabetes, affects nearly 20 million individuals in the United States and is one of the leading causes of limb amputation, coronary heart disease, and blindness. Avandia assists in controlling the blood sugar levels in patients with this condition, and is commonly used in combination with insulin, diet, and exercise regiments. Experts estimate that close to a million individuals in the United States and close to 2 million individuals worldwide are taking or have taken Avandia in treating their Type 2 diabetes.

The typical side effects of Avandia include headache, sinusitis, cough, back pain, and fluid retention. A much less common side effect is macular edema, a condition causing swelling in the back of the eye, characterized by the development of blurry vision or a decrease in viewing ability. Avandia belongs to the same class of medications as Rezulin, a drug associated with liver damage, so patients are warned to be on the lookout for any symptoms indicating that damage is occurring to the liver, such as stomach pain, nausea, vomiting, fatigue, loss of appetite, or jaundice.

Since the medication’s release to the public in 1999, the FDA has been tracking incidences of adverse heart-related events occurring in connection with Avandia. The FDA has also required the data on the warning label of the medication to be updated several times to reflect new information relating to the side effects and complications associated with taking Avandia, with the most recent update occurring in 2006. Then, in May of 2007, the New England Journal of Medicine released an article detailing the results of 40 studies conducted by researchers that note the adverse effects of Avandia use on the cardiovascular system.

An analysis of the data from the clinical trials concluded that patients taking Avandia have a much higher risk of heart attack and heart related deaths than patients taking a placebo. The studies found that individuals taking Avandia for short term treatment had a 30% to 40% greater risk of having a heart attack or experiencing other adverse, heart related events. In one clinical trial, named the Dream trial and intended to see whether Avandia could be a diabetes preventative, researchers found that individuals using Avandia experienced 66% more heart attacks, 39% more strokes, and 20% more cardiovascular related deaths than the patients issued a placebo.

The release of this new information caused the FDA to issue a public safety alert and request that doctors and patients discuss this latest development and any cardiovascular issues the patient may be experiencing. GlaxoSmithKline has issued a press release stating their disagreement with the article’s findings and suggests that the analysis was based on incomplete evidence. The FDA’s analysis of the data is ongoing and for this reason, they have not requested that GlaxoSmithKline take any action at this time. It is estimated that thousands of individuals have experienced adverse cardiovascular related events as a result of taking Avandia.

If you or a loved one have taken Avandia® and suffered any adverse side effects, you should contact us immediately. You may be entitled to compensation and we can help.

Do I have an Avandia Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Avandia lawsuits. We are handling individual litigation nationwide and currently accepting new Avandia cases in all 50 states.

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