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Published on 8 July 2009

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Banned painkiller cleared in the US

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Opiod painkillers banned as too dangerous in Britain have been approved by the Food and Drug Administration (FDA) for continued sale in the US.

This is despite the fact that European regulators have now also recommended that the drugs – Darvocet, Darvon and their propoxyphene generics – be taken off the market.

The drugs were banned in Britain several years ago after a spate of suicides and accidental overdoses, and US consumer watchdog Public Citizen has urged an American ban for the same reasons.

The agency has also asked Medicare and the Veterans Affairs Department to assist in studying the drug’s specific effects on the elderly.

But the FDA has ignored these fears, acting only to ensure that warnings are clearly stated on the label and that patients receive a special pamphlet stressing the risk of overdosing.

The half-century-old drug is widely used in the US, even though doctors consider it a weak pain reliever.

Meanwhile, the drug`s manufacturer, Xanodyne Pharmaceuticals, has been ordered by the FDA to study the effect on patients’ hearts of higher-than-recommended doses.

Copyright Press Association 2009

FDA



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