Further warning for diabetes drug box

Thu, 15 Nov 2007
Controversial diabetes drug Avandia will now carry a further ‘black box’ warning from manufacturer and pharmaceutical company GlaxoSmithKline. The label will clearly indicate that Avandia can cause both chest pain and heart attacks.

The regulation is currently only in place in America, where the US Food and Drug Administration have called for the warning. Glaxo have also confirmed that they are undergoing a trial with rival Takeda’s drug Actos and other diabetic drugs to see if Avandia risks are unique.

The FDA advised doctors to keep a close eye on patients taking Avandia, and to look out for any influence on the heart. Dr. Janet Woodcock, speaking on behalf of the Food and Drug Administration, reportedly commented: "We are keeping Avandia on the market because we have concluded that there is not enough evidence to conclude that the risk for heart attack or cardiac ischemia is higher than for other type-2 diabetes drugs."

Sales of Avandia have slipped considerably since a US study linked the drug to a 43 per cent increased risk of heart attack. The drug was the second largest of the Glaxo stable.
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