News Tagged ‘strokes

FDA approves new warnings on Avandia packaging

images2 100x100New warnings for the type 2 diabetes drug , better known by the brand name Avandia, has been approved by the Food and Drug Administration (FDA). The warnings, including a black box warning, will be immediately added to the safety labeling and packaging for ( maleate), as well as other drugs with the same active ingredient, including Avandament ( maleate/metformin hydrochloride), and Avandaryl ( maleate/glimepride).

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GSK to pay $460 million to settle Avandia lawsuits

While an expert panel in the U.S. reviews evidence to decide whether to pull the popular diabetes drug Avandia off the market due to an increased risk of cardiovascular events, BusinessWeek reports that the drug’s maker, GlaxoSmithKline (), has agreed to pay about $460 million to settle alleging the company hid evidence that increased the risk of heart attacks and strokes. faces more than 13,000 and has agreed to settle about 10,000 of them. was to face its first trial in federal court in October. BusinessWeek reports that the FDA review helped prompt the company’s decision to settle the suits.

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