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Drug Linked To Liver Failure

Oct 30, 2003 | A CONTROVERSIAL anti-depressant drug linked to fatal liver failure will still be sold in Australia despite its removal from Canadian and European markets and calls for it to be banned in the US.

Serzone is prescribed in Australia for the treatment of serious depression.

The Australian MIMS prescribers manual warns doctors of a potential for severe liver injury from Serzone and it is not recommended for patients with liver disease.

A US consumer group is calling on US medicines regulators to ban the drug after a string of deadly liver failures.

Dr Sidney Wolfe of the group Public Citizen wrote to the US Food and Drug Administration (FDA) urging authorities to "remove this drug from the market before more people are injured or killed".

Dr Wolfe cited 55 cases of liver failure including 20 deaths since 1994 and claimed reports of side-effects were increasing.

He said it was impossible to predict which patient would develop liver failure, which was an unacceptable risk given Serzone was no better than older drugs without the side effect.

Clinical and research psychiatrist at the University of NSW, Ian Hickie, said reports of liver failure related to Serzone were cause for serious monitoring but were extremely rare.

"The issue about liver toxicity has been known for some time and that hasn't precipitated a rush to withdraw it in Australia," he said.

Dr Hickie also said the drug had a legitimate role as second or third line anti-depressant treatment for patients who were not responding to other drugs.

Earlier this month, Canada said Serzone would be taken off the market at the end of November, also saying there was no way of knowing which patients might experience liver failure.

Manufacturer Bristol-Myers Squibb quit selling Serzone in Europe last January, attributing the decision to low sales rather than safety concerns.

Bristol-Myers Australia said cases of liver failure among Serzone users were very rare.

"We will continue to make it available in Australia," spokesman Michael Moore said.

"It is an option for a certain group of patients."

Mr Moore said there had not been an increase in the rate of clinical reports of acute liver failure since a warning was put on the packet in 2001.

Comment was being sought from Australia's Therapeutic Goods Administration.

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