Glaxo has announced it will record a charge of 2.4 billion in the second quarter of 2010 to cover the cost of settling lawsuits. This is in addition to the 3.5 billion plus previously booked.
Also known as rosiglitazone, Avandia is an oral medication used to control blood sugar by making the body more sensitive to insulin. People with Type 2 diabetes continue to produce insulin but their bodies do not use it effectively.
Avandia has become a controversial treatment for Type 2 diabetes because its use appears to increase heart attack risk. Thousands of patients have filed lawsuits against GlaxoSmithKline PLC (formerly SmithKline Beecham), alleging that Avandia caused them to suffer heart attacks and other health problems.
The F.D.A. has split on whether to withdraw Avandia from the market or not. Some officials argue that the drug is useful despite its risks and others insist that it must be removed from the market. A 33-member FDA advisory panel voted July 14, 2010 to recommend that the drug remain on the market, but with tighter supervision and warnings about the danger of heart attacks.
The issue with Avandia is whether it raises the risk of heart attacks and cardiovascular problems more than other diabetes treatments. Avandia was linked to a 43% increase in heart attack risk in a 2007 study that was published in the New England Journal of Medicine. The advisory panel voted overwhelmingly that Avandia posed a higher heart attack risk than Actos, its nearest competitor.
The drug's manufacturer, GlaxoSmithKline PLC (formerly SmithKline Beecham), has been coming under fire for spending 11 years covering up their own study results (completed in the fall of 1999) that provided clear signs that Avandia was no better than Actos but was also riskier to the heart than Actos. The company did not submit the results to federal drug regulators, as is required in most cases by law.
Prior to 2007, hiding the results of negative clinical trials was widespread in the drug industry. In 2007 Congress mandated disclosures. But the disclosures are often little more than cryptic references. The issue of disclosure of negative drug studies is still not resolved.
Now, with tighter supervision and warnings about the danger of heart attacks Avandia will remain on the market.
Sources:
Diabetes Drug Maker Hid Test Data, Files Indicate
FDA Panel Says Keep Avandia on Market
If you or someone you know uses Avandia and has experienced heart problems please have them contact our Kansas City Law Office.
