FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear. Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus.

For more information, read the FDA press release at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html

Avandia is a diabetes drug in the same class as Rezulin, an FDA recalled drug in March 2000. The FDA sent a warning letter on July 17, 2001 saying that Avandia has falsely denied serious risk of congestive heart failure, hepatitis, and liver failure occurring in Avandia users. When Rezulin diabetes drug was recalled it was very controversial but the FDA claimed they were waiting to recall it until a safer alternative was found. Avandia was thought to be safer on the liver, although the FDA only claimed Avandia was only believed to be safer but still had the risk of causing liver toxicity.

The consumer group Public Citizen never found evidence that Avandia was a safe alternative. Approved on May 25, 1999, Avandia first had label changes made by the FDA on February 8, 2001. The Avandia revisions included warnings of cardiac failure and other cardiac effects, in addition to hepatic risk information. A February 22, 2001 letter was sent to Avandia manufacturer stating all Avandia promotional materials must be revised to include the new risks no later than March 8, 2001, however the manufacturer continued denying the risk existence at major meetings in addition to minimizing them in certain labeling pieces.

Avandia side effects can be very dangerous. Depending on the condition of the individual, including personal risk factors, Avandia side effects can have a much larger likelihood of occurring in some patients. It is essential to educate yourself on what medications you are prescribed so that if suffering Avandia side effects a patient will be able to take the proper measures in making sure the condition does not worsen.

The Avandia side effects can range from mild to life threatening. Included on Avandia labeling are the warnings that Avandia side effects can be as serious as cardiac events, including failure, and hepatic risks. When Avandia was first approved it was intended to replace the recalled diabetes drug Rezulin as a safe alternative because regulators did not associate as many Avandia side effects to it. Public Citizen consumer group never found that diabetes patients would suffer fewer Avandia side effects but the drug still remains.

Individuals that have experienced adverse effects from taking this dangerous drug should contact us immediately to learn about your legal rights and options.