Glaxo Settled Avandia Lawsuits. GlaxoSmithKline has reportedly settled around 700 Avandia lawsuits. According to a Bloomberg report, the drug maker has agreed to pay out $60 million to people who claimed the controversial diabetes drug caused them to suffer a heart attack or stroke.
While more than 4,000 Avandia lawsuits already have been filed, the company faces at least another 9,000 claims over the drugs that haven’t yet been filed under an agreement with Glaxo. Glaxo is scheduled to face its first Avandia trial in state court in Philadelphia in July, Bloomberg said.
Avandia has been the subject of safety concerns for several years. In November 2007, a black box warning – the FDA’s 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.
There is also speculation that the FDA could soon halt a large Avandia study called TIDE, which is comparing it to another drug called Actos. As we’ve reported previously, Actos has not raised as many safety concerns as Avandia, and some scientists inside and outside the FDA have said it is unethical to compare a drug with known cardiac risks with a seemingly safer alternative.
In March, FDA Commissioner Margaret Hamburg wrote to Senator Charles Grassley (R-Iowa), one of the signatories of the senate Finance Committee report, telling him that the agency is reassessing the Avandia versus Actos trial “based on expert input and our own analysis.”
Last month, Joshua Sharfstein, Hamburg’s principle deputy, told The Wall Street Journal that whatever decision is made regarding TIDE, it “cannot be de-linked from the agency’s view of Avandia.” This, the Journal said, indicates that if the FDA halts TIDE, it could also ask Glaxo to halt sales of Avandia.
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