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ADA Avandia recommendations

Executive Summary

The American Diabetes Association is not changing its treatment guidelines, but is urging physicians to exercise caution in prescribing thiazolidinediones, particularly GlaxoSmithKline's Avandia (rosiglitazone). Treatment with Avandia or Takeda's Actos (pioglitazone) remains as a second-line option for diabetics unable to control their hemoglobin levels with metformin on ADA's treatment algorithm, but recent safety concerns with TZDs "should prompt clinicians to consider more carefully whether to use this class of drugs vs. insulin or sulfonylureas as the second step in the algorithm," the group advises. ADA's consensus statement, updated Nov. 27, notes that "in addition to the concern raised regarding the potential risk of myocardial infarction with rosiglitazone, the previously recognized risk of fluid retention and resultant CHF, which applies to both pioglitazone and rosiglitazone, has now been quantified as an approximately two-fold increase." The emerging safety signals have led FDA to add a "black box" warning about the risk of congestive heart failure to TZD class labeling, and more recently a "boxed warning" about a potential risk for heart attack to the Avandia label (1"The Pink Sheet" Nov. 19, 2007, p. 3)...

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