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FDA Missing in Action on Avandia

May 25, 2007

An analysis linking the widely used diabetes drug Avandia to higher risk of heart attacks represents a serious blow to GlaxoSmithKline PLC and underscores how outside critics have been empowered to challenge big-selling drugs after the outcry over the withdrawn painkiller Vioxx.

Glaxo rang up more than $3 billion in world-wide sales of Avandia last year. Its share price fell more than 7% after the New England Journal of Medicine released the analysis by prominent cardiologist Steven Nissen of the Cleveland Clinic, who helped raise early safety concerns about Vioxx. The analysis suggested that people on Avandia have a 43% higher chance of suffering a heart attack.

[…]

One issue coming under congressional scrutiny is whether the Food and Drug Administration should have acted faster to alert the public about possible risk from Avandia. Glaxo performed its own meta-analysis, which also showed a potential danger. It shared an early version of it with the FDA in September 2005 and a more complete one in August 2006. The findings weren’t reflected on the U.S. label, which is supposed to give a comprehensive review of the drug’s risks.

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