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Pharmaceuticals News South Africa

Drug for diabetes may be banned in the US

A major consumer group in the US has asked the Food and Drug Administration to ban the diabetes drug rosiglitazone.

Rosiglitazone, which is prescribed in type 2 diabetes, has already been linked with an increased risk of heart attacks, heart failure, bone fractures and eye problems. Now there also appears to be a risk of serious liver disease - which is newly documented. The group calling for the drug to be banned are known as Public Citizen, one of the most powerful consumer groups in the US.

The drug already carries a 'black box' warning from the FDA saying that it may cause heart attacks and congestive heart failure.

GlaxoSmithKline issued a statement saying it believed there to be no issue of liver safety with rosiglitazone. The company said that an external safety board reviewed liver problems that might be related to rosiglitazone. "As recently as July 2008," the statement said, 'this panel of experts continued to endorse a favorable hepatic safety profile for rosiglitazone (Avandia).'

In its petition to the FDA, Public Citizen said that toxicity associated with rosiglitazone was not outweighed by its benefits. It said that a working group with representatives from the American Diabetes Association and the European Association for the Study of Diabetes had unanimously advised against the drug.

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