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serzone banned in aust

Posted by kw on January 23, 2004, at 5:54:31


Depression pill removal to affect thousands
By Julie Robotham, Medical Editor and agencies
January 23 2004


Thousands of Australians with mood disorders will be forced to switch to another antidepressant or cease medication altogether after the manufacturer of Serzone decided to take it off the market from May.

The chairman of the Royal Australian and New Zealand College of Psychiatrists' committee for psychotropic drugs, Bill Lyndon, said the transition might prove difficult for some patients.

Dr Lyndon said this was because Serzone, which has been linked to rare but potentially fatal liver damage, caused fewer sleep and sexual problems than other drugs.

He said Serzone, which is made by Bristol-Myers Squibb, might be the only medication that worked for some people.

"It's disappointing to lose a drug which does help some people," he said. "The bigger the variety, the better off people are."

But most patients would "be able to transfer uneventfully" to a different medication, Dr Lyndon said, and the college would not be asking the Federal Government to treat Serzone as an "essential drug", a category that can make a drug available under special provisions after a manufacturer stops selling it.

Serzone continues to be available in the US, where it is widely used especially in geriatric patients, despite being linked to 55 cases of liver failure, including 20 deaths, since 1994.

The decision to withdraw Serzone comes amid mounting concern worldwide about the side effects of antidepressants.

The clinical adviser to the depression initiative beyondblue, Ian Hickie, said a small minority of patients would be at risk of a relapse of the condition. But most of those whose depression had stabilised while on Serzone would be able to find another drug that worked for them.

"Doctors need to take the opportunity of looking at whether people need to be on medication at all," Professor Hickie said.

Some people remained on antidepressants indefinitely, he said, when doctors should try to wean patients off drugs and offer them psychological treatments instead.

Bristol-Myers Squibb issued a statement saying it would no longer market Serzone in Australia, "because of its current low and declining rate of use". The company has already withdrawn Serzone in Europe, citing the same reasons. But in Canada, health regulators banned its use.

Australia's Therapeutic Goods Administration is reviewing the safety of the widely used selective serotonin reuptake inhibitor (SSRI) class of antidepressants in children and adolescents.

The review follows advice from the British Government that only Prozac should be used by under-18s because other drugs might make them agitated or suicidal. A similar review is under way in the US.

But yesterday, psychiatrists from the American College of Neuropsychopharmacology defended the use of mood-altering medicines in children.

The college said there there was no strong evidence the medicines increased suicide risk.

J. John Mann, a Columbia University professor of psychiatry and co-chairman of a college task force addressing the controversy, said: "Depression in children and adults is the major illness that underlies suicide, and we believe that the SSRI class represents the medication with the greatest efficacy against this very serious condition."

sydney morning herald


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poster:kw thread:304517
URL: http://www.dr-bob.org/babble/20040122/msgs/304517.html