Avandia Side Effects Reaffirmed With New Studies

The diabetes drug Avandia has made headlines again with disheartening news about serious side effects claimed by research studies. Listed as the world's top-selling diabetes prescription medication, another medical research study calls attention to serious health problems resulting from the use of this drug. Increased risk of heart attack, heart failure, and stroke are reportedly stemming from patients using Avandia. This news comes at a time of uncertain fate for the popular diabetes medication, as a federal hearing by the Food and Drug Administration is scheduled for July 13 and 14 to determine the destiny of Avandia for diabetic patients.

Avandia, also known as rosiglitazone, first gained approval for marketing and distribution in 1999, and is manufactured by GlaxoSmithKline, a leader in the pharmaceutical industry. The prescribed use of Avandia is for patients suffering from Type 2 diabetes, acting by controlling blood sugar levels without the use of insulin. Thought of as a miracle drug, Avandia soon replaced most other diabetic medications making it the most used drug of its kind on the market in the world. As a leader in the anti-diabetic drugs, Avandia showed great hope and promise for diabetics.

Studies determining the effects of the Avandia continue as medical professionals are trying to determine if the negative side effects outweigh the benefits of using the drug. A clinical trial, known as RECORD, Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation, was conducted by GlaxoSmithKline using a randomized sample of 4,447 patients. The trial found any incidents of increased health risks to be similar to patients taking other prescription diabetic medications, and GlaxoSmithKline say that while their findings stand in contrast to the findings of other studies, their clinical trial is accurate and precise.

However, Avandia has been linked to increased risk of bone fractures and heart failure. By 2007, several studies analyzed determined with an overwhelming majority that using Avandia leads to an increased risk of heart attack. The most recent study released on Monday found Avandia users' risk for heart attacks increased by 28% to 39%, and can be found online in the Archives of Internal Medicine. An additional study discovered that diabetic patients using Avandia have an increased risk of death from any cause by 13%, an increased risk of stroke by 27%, and heart failure by 25%. This study came from a pool of Medicare recipients, and can be found online in the Journal of the American Medical Association.

Dr. Steven Nissen, the lead author of the study conducted by the Archives of Internal Medicine, the analysis of studies conducted in 2007, and chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation, said, “We have two studies done by independent groups, published in very responsible journals using different approaches coming to the same conclusion. It's everything we know about this drug during its very sad and unfortunate history.”

On the other end of the spectrum of research surrounding Avandia, the American Diabetes Association study shows that the drug did not lead to an increase in cardiovascular issues or death in comparison with similar diabetic medications. However, this study was a review of other completed studies, and lacks in original research or data. Also, the study included patients with both Type 2 diabetes and heart disease.

The most comprehensive study, lead by Nissen, consists of analysis of 56 studies, including the RECORD clinical trial from GlaxoSmithKline, and a total participant pool of 35,531 patients. The findings of this study show that there is an increased risk of heart attack among Avandia users.

Great debates and extensive research over the past decade result in mixed conclusions regarding the health concerns and risks associated with Avandia. While studies show increased risks in cardiovascular events, others show that these events would occur had the diabetic patient used other anti-diabetic medications. The American Diabetes Association consensus panel recommends the cease and desist of doctors prescribing Avandia. The United States Committee on Finance charged the Food and Drug Administration in February with knowingly permitting the distribution of the drug whilst they understood the increased cardiovascular risks, and is calling for an immediate removal of Avandia from the market.

If you or a loved one has experienced serious side effects, a heart attack or other health complications from using Avandia, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.
 

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