Monday, July 12, 2010

Avandia: FDA Reviewers Suggest the Drug's Withdrawal

Avandia should be pulled from the market because of the "serious" cardiovascular risk the diabetes drug poses, which exceeds that of competitor pioglitazone (Actos), FDA staff reviewers again recommended.Rosiglitazone is no more effective at improving glycemic control in type 2 diabetes than pioglitazone and provides no known unique health benefits, and while both drugs increase the risk of congestive heart failure, rosiglitazone's effect is "substantially greater," FDA reviewers wrote in a massive briefing document released Friday

In the FDA reviewers' analysis, the hazard ratios with rosiglitazone versus placebo were:
  • 1.42 for MI (95% lower confidence limit 0.93, 95% upper confidence limit 2.16)
  • 0.96 for strokes (95% LCL 0.60, 95% UCL 1.54)
  • 0.95 for cardiovascular death (95% LCL 0.57, 95% UCL 1.60)
  • 1.13 for major adverse cardiovascular events (95% LCL 0.85, 95% UCL 1.50)
 More here.
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