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As FDA Reviews Avandia, GlaxoSmithKline Resolves Lawsuits


5 dollar bill rolledGlaxoSmithKline Plc, manufacturer of Diabetes drug Avandia, has agreed to pay $460 million to settle a number of lawsuits which assert that Avandia causes heart attacks and strokes. The settlement comes in part as a result of today’s panel which is meeting to recommend to the U.S. Food and Drug Administration (FDA) whether or not Avandia should be taken off the market or restricted due to its affects including heart attacks, stroke, and death. GlaxoSmithKline has agreed to settle 10,000 lawsuits for an average of $46,000 each. The drug manufacturer is facing more than 13,000 cases (3,000 of which or more are still pending) stating that GlaxoSmithKline has not released information about the drug’s adverse affects and increased risks of heart attacks and strokes. GlaxoSmithKline will face its first trial due to Avandia in federal court in Philadelphia in October (Case: In Re Avandia Marketing, Sales Practices and Products Liability Litigation, 07-01871, U.S. District Court for the Eastern District of Pennsylvania (Philadelphia)). The company set aside $3.5 billion in March for “legal and other disputes” but did not specifically reference Avandia.

Results of the affects of Avandia have driven the need for the panel. For instance, while Avandia was at one time the world’s best-selling diabetes pill, it only generated $1.1 billion in 2009 due to a 2007 study which found a 43 percent increased risk in heart attacks for Avandia users. Some studies specifically may even be considered by the panel. For example, Dr. Rosemary Johann-Liang, a former manager in the FDA’s drug-safety unit, stated that in 2001 a study revealed that Avandia posed more threat to heart attacks than its rival prescriptions. Dr. Thomas Marciniak, who works in the FDA’s Office of New Drugs, has also conducted a study which will be considered. He analyzed GlaxoSmithKline’s major clinical trial of Avandia and has found that it may lead to an increased risk of art attacks and stroke.

Source: Feeley, Jef and Trista Kelley. “Glaxo Said to Pay $460 Million to Settle Avandia Damage Suits.” Bloomberg. 13 July 2010.



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