Avandia, the best-selling oral diabetes treatment in the world, lowers blood sugar levels, which can cause complications including kidney and eye damage, by increasing the body's sensitivity to insulin. Avandia (rosiglitazone) is taken by more than 1 million people in the U.S., but recent studies have linked its use to congestive heart failure, hepatitis and liver failure.
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A May 2007 study in the New England Journal of Medicine states that the popular drug may raise a patient’s chance of having a heart attack, or suffer a heart-related death. Based on those published results, the U.S. Food and Drug Administration (FDA) issued a safety alert on the drug. A few weeks after that, the FDA asked for a black-box warning about congestive heart failure be added to the labels of Avandia and a related drug, Actos.
Avandia, manufactured by GlaxoSmithKline Plc, was approved by the FDA in 1999, and was developed to help control blood sugar in adults with Type 2 Diabetes. The drug is used by nearly seven million people worldwide, and generates billions of dollars in sales. However, an article appearing in the June 14, 2007 edition of the New England Journal of Medicine details a recent analysis of clinical trials suggesting that the drug significantly increases the risk of heart attacks and cardiovascular death. The study was conducted by doctors at the renowned Cleveland Clinic and was published on May 21, 2007.
The trials compared patients taking Avandia with those not using the drug. The results indicate that Avandia users had an increase of cardiac-related deaths by 64 percent and 43 percent increase in heart attacks.
In its May safety alert, the U.S. Food and Drug Administration said patients taking Avandia, especially those with heart disease or at high risk of heart attack, should talk to their doctor about the risks. Lawsuits concerning Avandia have resulted because of the serious side affects associated with its use.
Since approving Avandia in 1999, the FDA has updated the product’s labeling on several occasions to reflect new data that showed patients taking Avandia alone and in combination with certain other drugs may suffer side effects such as fluid retention, edema and congestive heart failure. The most recent label change was in 2006, when the FDA ordered warnings about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia.
The consumer group Public Citizen has said that it had repeatedly warned the Glaxo and the FDA about the dangers of Avandia, stating that the drug should only be a “last-choice” option for the treatment of type 2 diabetes because studies have shown it to cause serious cardiac problems.
If you or someone you care about is currently taking Avandia for type 2 diabetes, contact your doctor immediately. Then, contact Barry & Lowey, LLP to speak with one of our lawyers. Your case will be evaluated for free, and we will let you know whether you have a valid case against the drug manufacturer.
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Our firm maintains offices in both Austin and San Antonio, Texas, and we represent clients throughout the nation. Call us today, at (800) 892-5044, or contact us here.
