FDA PANEL MEMBERS VOTE TO RECOMMEND NEW WARNINGS AND RESTRICTIONS ON THE DIABETES MEDICATION AVANDIA

On July 14, 2010, members of an advisory panel of the United States Food and Drug Administration voted to recommend new warnings and restrictions on the diabetes medication Avandia.  Avandia is a widely prescribed mediacation to treat Type-2 Diabetes Mellitus, also known as adult-onset diabetes.  

Avandia was approved for use by the FDA in 1999 and is manufactured by GlaxoSmithKline.  It is estimated that over 60 million prescriptions for Avandia have been written since it was approved.  In the last several years, grave concerns about the safety of Avandia have arisen.  In 2007, the New England Journal of Medicine published a study authored by Dr. Steven Nissen.   This study evaluated 42 clinical trials involving Avandia and found that it increased the risk of heart attack by 43% and death by cardiovascular event by 64%.  This would include heart attack (myocardial infarction), stroke, aneurysm, congestive heart failure and arrhythmia.  It has been suggested that Avandia has been linked to 83,000 heart attacks since the drug hit the market in 1999.  

On May 21, 2007, the FDA issued a safety alert regarding Avandia. Later, on November 17, 2007, the FDA approved a "black box warning" for Avandia relating to potential increase in heart attacks and heart-related chest pain in some patients using Avandia. This week, the New York Times reported that in 1999, GlaxoSmithKline began its own study comparing the safety of Avandia to a competing drug called Actos.  The results of the study were disastrous - not only was Avandia no more effective in the treatment of diabetes than Actos, but Avandia was shown to be much more dangerous to the heart.  According to the New York Times, GlaxoSmithKline then spent the next 11 years trying to hide, keep secret and cover up the results of its own testing on the safety of Avandia.

HOW WE CAN HELP

The lawyers at Parker McDonald, P.C. have years of experience in serving the victims of dangerous drugs and medical devices and have recovered hundreds of millions of dollars on behalf of their clients.  There is a limited amount of time in which to bring a claim if you or a loved one has suffered a heart attack, stroke, congestive heart failure or death as a result of using Avandia.  Please contact us immediately for a free claim evaluation using the form on the right or call us collect at 817-513-9200.