GlaxoSmithKline PLC has reportedly agreed to pay $60 million to settle about 700 Avandia lawsuits filed over side effects of their diabetes drug. However, the drug maker still faces thousands of other similar suits filed throughout the United States alleging that they failed to adequately warn about the risk of heart attacks, heart failure and other injuries.
The Avandia settlements were reached to between Glaxo and two law firms representing hundreds of clients, sources told Bloomberg News. The agreement is believed to be the first settlement of Avandia injury claims brought by users, and Bloomberg reports that the drug maker is continuing negotiations to settle Avandia lawsuits with other lawyers.
Avandia (rosiglitazone) was approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years as concerns have mounted about the risk of serious and potentially life-threatening heart risks with Avandia. Some experts estimate that Avandia has caused between 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1999 to 2006.
Concerns about the risk of heart problems with Avandia first gained widespread attention in May 2007, when a meta-analysis of 42 different clinical trials was published in the New England Journal of Medicine, suggesting that users of Avandia had a 43% increased risk of a heart attack.
In the United States, GlaxoSmithKline PLC currently faces thousands of lawsuits over Avandia filed by former users of the drug who allege that the drug company failed to adequately research their medication or warn users about the serious side effects. Federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania, where the first trial is expected to begin in July.
Details of the agreement are unknown, including the nature of the injuries involved in the cases. However, the Avandia settlement breaks down to an average of about $86,000 per plaintiff.
Pressure to resolve the Avandia cases has increased in recent months with the first trials approaching and a renewed push by critics for a recall of Avandia to be issued.
Earlier this year, a Senate report was released that criticized GlaxoSmithKline for intimidating doctors who spoke out about Avandia side effects and for failing to adequately warn users about the risk of a heart attack from side effects of Avandia.
Last week, at a House Agriculture Appropriations subcommittee hearing, several lawmakers entered testimony criticizing the FDA for not issuing an Avandia recall and questioning how the drug was ever approved in the first place.
FDA is currently conducting an Avandia safety review and estimates that it will conclude its investigation some time in July. Some of the FDA’s own drug reviewers said as early as 2007 that Avandia poses too great of a health risk for too few benefits. The FDA is considering pulling the plug on an Avandia study, called TIDE, which is looking at the side effects of Avandia compared to those of Actos, a competing diabetes medication manufactured by Takeda Pharmaceuticals. The FDA says that given the Avandia heart attack risks, it may be unethical to continue the trials.