U.S. Senate Releases Report on Avandia
Posted by PKSD Law Firm on Feb 22, 2010 in Dangerous Drugs
The Senate Finance Committee released a report on Saturday that said drug-manufacturer GlaxoSmithKline was aware of the possible heart attack risks to Avandia users years prior to the publics knowledge.
The report also asks why the FDA allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks from 1999-2007. The FDA ordered a black-box warning to be included on the label in 2007, saying the drug might increase the risk of heart attacks.
The committees report was based on researchers studies of Avandia, internal GlaxoSmithKline documents and FDA documents.
A New England Journal of Medicine analysis published in 2007 found a 43% higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medications.
Glaxo has agreed to conduct a 6-year study between Avandia and a competitors diabetes medication to better understand Avandias safety. The FDA calls the study, which includes 16,000 participants, unethical and exploitative because patients will continue taking Avandia.
Avandia controls blood sugar by increasing the body's sensitivity to insulin. Avandia was Glaxos third best-selling drug in 2006, making $2.2 billion, however, concerns about the drugs safety caused revenues to fall to $1.2 billion.