GlaxoSmithKline Settles Avandia. Thousands of Avandia lawsuits that were scheduled to come to trial in a state court in Philadelphia, PA this month have been settled. According to a Reuters report, half of the estimated 13,000 Avandia lawsuits filed against GlaxoSmithKline have now been settled.
There were around 5,000 Avandia lawsuits consolidated in the Philadelphia case, which was scheduled to go to trial yesterday. A GlaxoSmithKline spokesperson told The Wall Street Journal that the next case slated for trial in that court and is to begin in October 2010. None of the Avandia cases consolidated in federal court have been resolved.
The latest settlement follows the separate resolution of some 700 cases for about $60 million that we reported last month.
Most Avandia lawsuits have been filed by people who claim the diabetes drug caused them to suffer a heart attack or stroke. Avandia has been the subject of safety concerns for several years.
A black box warning – the Food & Drug Administration’s (FDA) strongest safety warning
In November 2007, a black box warning – the Food & Drug Administration’s (FDA) strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling.
The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack.
Earlier this year, the Senate Finance Committee released a report detailing its 2-year Avandia investigation. According to the report, in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks.
Since the release of the Senate report, calls have increased for the FDA to pull Avandia off the market. The FDA is conducting another safety review of Avandia, the results of which will be discussed at a public meeting in July.
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