AVANDIA FACTS
Generic Name: Rosiglitazone
Date Approved: May 25, 1999
Manufacturer : GlaxoSmithKline
Approved Uses: Type 2 Diabetes
Status:
On the market
December 2005 Manufacturer warning letter
January 2006 FDA & Manufacturer warning
Serious Side Effects:
Heart Attack
Stroke
Congestive heart failure
Food and Drug reviews from the FDA have linked Avandia to tens of thousands of heart attacks. Despite these findings, Avandia has been allowed to remain on the market and continue to endanger lives. If you are among the many victims, who have taken Avandia and suffered a heart attack, Hach & Rose would like to discuss with you how you can protect your legal rights.
In February 2010, a Senate Finance Committee released findings that GlaxoSmithKline, the maker of Avandia, potentially knew about the drugs risks as early as 1999 and kept this information from the public. If you have suffered from this deception, we can help you make sure that GlaxoSmithKline is held accountable for its failure to warn patients about the serious heart risks from taking Avandia. You may also be eligible to receive compensation for your medical bills, lost wages, and pain and suffering.
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Avandia is among a class of drugs approved by the FDA in 1998 for treating type 2 diabetes by helping control blood sugar levels. In 2006, 13.2 million people had taken Avandia. In the following years, growing concerns about its side effects caused that number to drop to only 4.6 million. This concern was sparked when an analysis of 42 clinical trials published by a Cleveland Clinic cardiologist showed that patients taking Avandia had a 43% higher chance of having a heart attack. In November of 2007, the FDA issued its strongest safety warning, which detailed Avandia’s association with myocardial ischemia, and added this warning to the drug’s label. According to the New York Times, Avandia was linked to 304 deaths during the third quarter of 2009 alone, well after the FDA and Senate were aware of its risks.
After a 2 year investigation, the Senate Finance Committee released a report in 2010, which states that 500 heart attacks and 300 cases of heart failure could be avoided each month if diabetics were treated with different medication. According to this report, the FDA’s own reviewers of the drug had recommended that Avandia be taken off the market as early as 2007. Furthermore, an October 2008 internal FDA memo also recommended that Avandia be removed from the market because of heart risks, but no action was taken. The report contains evidence that the FDA linked Avandia to an estimated 83,000 heart attacks. These could have been avoided if Glaxo had not attempted to undermine the criticism of the drug. Mr. Baucus, a senator in charge of overseeing the report, said, “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”
Glaxo is currently attempting to conduct a large clinical trial called TIDE. However, sites such as Wake Forest University Medical Center have withdrawn the safety study because of failure to recruit patients, potentially due to the increasing knowledge of Avandia’s harmful side effects. Some advocates have called the study unethical because patients are being given Avandia, which has already been linked to serious cardiovascular problems. Glaxo has also been adding sites in developing nations, where patients may not be aware of the potential health risks.
The Senate Report on Avandia paints a disturbing picture of both the FDA’s and Glaxo’s failure to put their patients’ health first. Had they paid attention to the risks, thousands of heart attacks could have been prevented. If you or a loved one have suffered a heart attack from taking Avandia, do not hesitate to call us to discuss your legal rights. Together, we can make sure that Glaxo is held accountable and help others who may be at risk.
