DESCRIPTION: GlaxoSmithKline's Avandia was approved in May 1999 for treatment of type II diabetes mellitus—as monotherapy or in combination with metformin. In February 2001, the FDA required the company to include a new label warning regarding cardiac failure related to the combination of Avandia and insulin. The agency cited two 26-week studies involving 611 patients, which demonstrated an increased incidence of heart failure in patients using the combination, compared to insulin plus placebo. Further, 3 of 10 patients who developed heart failure while taking Avandia plus insulin had no known prior evidence of congestive heart failure or pre-existing cardiac failure.
 

Even after the FDA's call for the new warning, GlaxoSmithKline salespeople continued to recommend that physicians prescribe the combination. In May 2001, the FDA's Division of Drug Marketing, Advertising and Communication issued a warning letter to the company, which in turn sent physicians a "Dear Dr." letter.

Clinical evidence shows that Avandia, when taken in combination with insulin, can result in fluid-overload disease, leading to congestive heart failure and death. The drug has not been removed from the market, nor do clinical studies find this risk with Avandia alone. Unlike Rezulin, Avandia is not being removed from the market; the danger involves combination therapy of Avandia and insulin alone; and there is not a related risk of hepatic damage.

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