Avandia Lawsuits
Avandia (rosiglitzaone) is a drug that has been used to treat type 2 diabetes. Avandia, the brand name drug manufactured and marketed by GlaxoSmithKline, is used along with diet and exercise to help lower blood sugar levels. Since 1999, Avandia has been prescribed to over 4 million people with type 2 diabetes. Avandia was intended as a safer alternative to Rezulin, which was recalled in 2000 for being linked to fatal liver diseases.
However, in May 2007, the Food and Drug Administration (FDA) issued a safety alert on Avandia. The FDA said that data from controlled clinical trials showed that there is an increased chance of heart attack or heart-related illnesses for patients taking Avandia. The reason that the drug was not immediately removed from the market is that other long-term clinical trials showed contradictory evidence about the risks of taking Avandia. The FDA did said in it’s safety alert that patients who have heart disease or are at a higher risk for heart attack should talk to their physician about these clinical trial findings to decide if they should proceed with taking Avandia to treat their diabetes.
Dr. Steven Galson, the director of the FDA’s Center for Drug Evaluation and Research department, said, “FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In this case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia. We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened.”
GlaxoSmithKline provided the FDA with a pooled analysis of 42 randomized, controlled clinical trial results. Those showed that Avandia used for six months by patients could have raised their risk of heart attack or other heart illnesses by as much as 30-40 percent.
Avandia lawsuits are starting to pop up as some patients who have taken it are suffering from heart attacks, congestive heart failure, hepatitis, and liver failure. A new study was reported in the September 9, 2007 issue of Mayo Clinic Proceedings that suggested that Avandia could cause fluid accumulation that results in congestive heart failure. In the study, six men between the ages of 66 and 78 who were taking Avandia had to go to the Dallas Veterans Affairs Medical Center for congestive heart failure.
Since being approved, many FDA officials have questioned whether Avandia should stay on the market or not, but put off a ban on the medication until the results of further research are established. If you or someone you know has been taking Avandia and suffered liver failure, hepatitis, congestive heart failure, a heart attack, or any other type of heart ailment, you should contact a lawyer to find out your legal rights.