Avandia FDA Warning
Avandia is a trade name for the generic drug rosiglitazone, developed and marketed by GlaxoSmithKline. Avandia was first approved by the U.S. Food and Drug Administration (FDA) in 1999 as a treatment for the control of Type 2 diabetes. Since that time, tens of thousands of reports have flooded into the FDA concerning severe, and sometime deadly, side effects of the drug. Avandia has been called a "nightmare" for the FDA, fueling allegations that the agency approves dangerous drugs before they are fully tested.
Avandia Approval
The FDA approved Avandia in 1999 even though some studies showed a risk of heart disease and liver failure. Government reports show that Avandia was approved for use before clinical trials were complete. Clinical trials continued through 2007 even though approximately 83,000 heart attacks were linked to the drug during that time. Sales of Avandia peaked in 2006 at $2.5 billion, and in 2010 6 million adults were estimated to have active prescriptions.
2007 Avandia Safety Alert
Although changes to the Avandia label were made in 2006, the FDA did not issue the first official safety alert regarding Avandia until 2007. The alert states that Avandia has the potential to significantly increase the risk of heart-related deaths, including deaths from heart attack. It was recommended that patients talk to their doctors about the risk, but no restrictions were placed on the drug.
The alert was based on a pooled analysis of several studies showing that patients taking Avandia have a 30 percent to 40 percent greater risk of adverse heart events than patients taking a placebo. In November of 2007, a boxed warning on the drug label was mandated concerning the risk of heart attack.
Avandia and Liver Failure
A study released in 2009 shows that Avandia may increase the risk of acute liver failure. The study stated that one case of liver failure occurs in every 44,000 patients taking Avandia. That same year, the FDA released its own analysis of the study. The FDA analysis concluded that the study may be incomplete or of poor quality. Therefore, no labeling changes were made and no safety warnings were issued.
FDA Restricts Avandia
In September 2010, the FDA announced that it would be restricting the use the Avandia in response to the data showing an increased risk of heart attack. Although the restriction was announced, it has been criticized for various reasons. Among those are why it was not immediately restricted.
The actual restrictions were not issued by the FDA until February 2011. The restrictions stated that new prescriptions should not be written and it should only be continued in patients who do not respond to other diabetes medications. In May, a further reminder with updated information on the restrictions was issued.
Getting Help
If you or a loved one have been taking Avandia and are concerned about the possibility of an adverse reaction talk with your doctor immediately about whether or not you should continue to use the drug. If you have been diagnosed with heart disease and are curious as to your legal options contact our Patient and Family Advocates about what you should know. They can answer most questions you may have and will be glad to assist in setting up an appointment with an experienced Avandia attorney if you wish to pursue a claim for damages.