GlaxoSmithKline has reached additional Avandia settlements in an estimated 5,000 lawsuits over the side effects of their diabetes drug, which has been linked to an increased risk of heart attacks and other potentailly life-threatening injuries.
Among the Avandia lawsuits settled were cases scheduled for trial to begin later this month in Pennsylvania, according to a report by Reuters. The first Avandia trial is now expected to begin in October 2010, unless additional settlements are reached.
Details surrounding the agreement to settle the Avandia claims have not been disclosed, but it is at least the second batch of cases resolved by the drug maker. Last month, Bloomberg News reported that GlaxoSmithKline agreed to pay $60 million to settle Avandia lawsuits brought by about 700 people represented by two law firms.
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 Avandia heart problems 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.
GlaxoSmithKline PLC currently faces about 13,000 Avandia lawsuit claims 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. The 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.
According to an earlier scheduling order issued by the federal judge presiding over the MDL, the first Avandia trial was expected to begin this summer. However, a modified scheduling order was issued last week granting an extension of time, indicating that lawsuits from the initial Avandia trial pill will begin October 5, 2010.
Pressure on GlaxoSmithKline to settle 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.
An Avandia safety review is currently being conducted by the FDA, and the drug regulatory agency 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 also 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.