GlaxoSmithKline has reportedly agreed to pay $460 million to settle Avandia lawsuits filed by about 10,000 more people. The agreement comes as two FDA advisory committees have begun meeting to debate whether the controversial diabetes drug should be recalled from the market.
The Avandia settlement was leaked to Bloomberg News the same day as the committees of independent advisors to the FDA were hearing evidence about the heart risks of Avandia that were the subject of the injury suits.
The settlement would resolve the majority of the outstanding Avandia lawsuits that have been filed against GlaxoSmithKline alleging that they failed to warn about the increased risk of heart attacks and other potentially life-threatening heart problems with Avandia.
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.
Speculation regarding the likelihood of an Avandia recall has reached a fever pitch in recent weeks, as more and more information about the Avandia heart problems has been released in advance of the FDA advisory committee meetings. Last week, the FDA released data showing that agency drug reviewers were conflicted over the drug’s benefits and risks, with some of them indicating that data Glaxo has touted as establishing Avandia’s safety is unreliable.
The proposed settlement of Avandia lawsuits allegedly range between $46,000 to $70,000, depending on the particulars and severity of the claims.
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. Therefore, the reported settlement would resolve the majority of cases currently pending. However, some Avandia lawyers are continuing to investigate and review new cases for individuals who continued to use the medication in reliance on GlaxoSmithKline’s misleading reassurances that the diabetes drug was safe.