FDA Mulls a Ban on Avandia

The FDA recently announced that it would consider whether to pull GlasxoSmithKline’s former top-selling drug, Avandia, off the market or allow it to stay on the market with stronger warnings after discovering evidence indicating that the drug may cause liver toxicity, resulting in liver failure and death.

This pronouncement comes after notable medical groups in the U.S. and Europe, including the American Diabetes Association and the European Association for the Study of Diabetes, asked doctors worldwide to no longer prescribe Avandia.

Furthermore, on Thursday, October 30, 2008, the consumer group Public Citizen specifically asked the FDA to ban the diabetes drug, indicating that in addition to increasing the risk of heart attack by 40%, there were many other life-threatening risks that far outweigh its benefits, including bone fractures and now the risk of liver toxicity. Public Citizen cited fourteen cases of Avandia-induced liver failure, twelve of which were lethal, that were discovered in the FDA Adverse Event Reporting System.

Although Avandia sales have fallen sharply since May 2007, Public Citizen said about 10,000 prescriptions are still being filled daily for Avandia. GlaxoSmithKline said Avandia and a related product that combines Avandia with another diabetes drug recorded world-wide sales of $313 million in the third quarter of this year.

Unsurprisingly, GlaxoSmithKline continues to claim that Avandia is safe and effective when used appropriately. However, safer and more effective drugs for Type 2 diabetes including Glucophage and Glucotrol remain on the market.

If you or a loved one were taking Avandia and have since been diagnosed with liver problems, please contact our office via our website at www.pbmattorneys.com for a free consultation so that we can work with you to protect your rights.