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Published on 16 November 2007

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Avandia given new warning labels


New warning labels have been issued in the US for the diabetes drug Avandia (rosiglitazone).

The packaging now tells patients and pharmacists that the drug may – or may not – increase the risk of heart attacks.

The Food and Drug Administration (FDA) has concluded that studies into the treatment are contradictory and fail to establish whether Avandia puts patients at a higher risk than other type 2 diabetes medications.
The black box on Avandia’s label, which is the most severe warning the FDA can issue, says that “the available data on the risks … are inconclusive”.

But it does go on to warn that Avandia may be associated with “myocardial ischemic events such as angina or myocardial infarction”.

Manufacturer GlaxoSmithKline has agreed to demands from the FDA to carry out a major study on the effect Avandia has on heart health.

Responding to whether Avandia presents a higher risk to patients than other diabetes drugs, Dr John Jenkins from the FDA said: “It’s still an open question. We want to make sure healthcare providers and patients are aware this signal of risk has been identified.”

The new warning labels come after regulators in Canada decided to restrict access to the drug for diabetics with particularly serious conditions.

Copyright © PA Business 2007


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