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Call for rigorous diabetes drug tests

A panel of experts has recommended to the US Food and Drug Administration that drugs to control Type II diabetes be subjected to more intensive cardiovascular trials
A panel of experts has recommended to the US Food and Drug Administration (FDA) that drugs to control Type II diabetes be subjected to more intensive cardiovascular trials.

The advisory panel voted 14-2 to recommend that all manufacturers of diabetes drugs conduct trials lasting up to five years to detect cardiovascular problems such as heart attacks and strokes.

The panel agreed that the requirement should apply to all experimental drugs. Several panel members were in favour of beginning this study before the drug's approval and completing it when it reaches the market. However, at least one panellist doubted these studies' ability to uncover heart risks and raised concern about the delay these additional trials may cause to important medical breakthroughs.

In most circumstances, the FDA will implement the recommendations of its advisory panels, although it has no legal obligation to do so.

According to Reuters, FDA officials said although diabetes drugs that work by controlling blood-sugar levels, help prevent some complications such as eye and kidney damage, there is no evidence that any diabetes drug reduces heart disease - the primary cause of death in diabetics.

3rd July 2008

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