Yesterday, a Food and Drug Administration (FDA) panel handed down a split decision regarding recommendations for actions to be taken with the diabetes drug Avandia. A majority of committee members (20 out of 33) voted to leave Avandia on the market but recommended imposing restrictions on its use. Twelve members voted to have Avandia pulled from the market altogether, while one member abstained from voting.
The vote occurred on the second day of hearings over Avandia’s safety, which has come under fire in recent years after several studies published in 2007 demonstrated a link between consumption of Avandia and an increased risk of heart failure.
While the majority of committee members voted to keep Avandia on the market, there is no guarantee that this will be the course of action taken by the FDA. The panel’s findings are merely recommendations; the FDA is free to take an alternate course of action if they believe it is in the best interest of consumers. The FDA is expected to make their decision on Avandia’s fate shortly.
During two preliminary votes, the FDA committee determined that Avandia does result in an increased risk of heart issues compared to alternative diabetes drug options; however, they found the evidence to be insufficient to warrant pulling the drug from the market.
GlaxoSmithKline, the pharmaceutical company that manufactures Avandia, continues to insist that Avandia is perfectly safe, despite the growing evidence to the contrary. However, Glaxo’s RECORD study, which is the primary study the company used to support their assertions, has been heavily criticized by the FDA as “inappropriate and biased.” According to the FDA, Glaxo regularly submitted sloppy data and failed to follow up on reports of problems experienced by patients, including reports of deaths associated with taking Avandia.
Furthermore, a Senate committee released documents on Tuesday which indicate that Glaxo “failed to publish studies that found serious health risks associated with Avandia in a timely manner and actively promoted the drug despite known safety concerns.” These documents include studies conducted as far back as 2000.
Sales of Avandia have dropped dramatically in recent years due to the growing safety concerns. In 2006, Avandia sales totaled approximately $3 billion annually. Now, they are roughly $1 billion. GlaxoSmithKline also currently faces numerous defective drug lawsuits in association with Avandia.
If you have an Avandia claim, please contact the defective drug attorneys at Schlichter, Bogard & Denton today to schedule your free initial consultation. Schlichter, Bogard & Denton serves clients nationwide.
