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Suicide warning urged for Prozac

March 25, 2004

AUSTRALIA'S drug regulator is pressing the makers of anti-depressants such as Prozac to produce labels warning of the drugs' potential risks, especially suicidal thoughts and behaviour.

The initiative by the Therapeutic Goods Administration follows a similar move by the US Food and Drug Administration in response to mounting concern about cases of adolescent suicide that have been associated with the person taking one of the SSRI (selective serotonin reuptake inhibitor) group of anti-depressants.

The FDA decided to act this week despite a lack of conclusive evidence linking SSRIs with adolescent suicide.

The SSRIs are a frontline treatment for depression and include brands such as Prozac, Zoloft, Aropax and Efexor.

A TGA spokesperson said that in 2000, pharmacies dispensed scripts for SSRIs worth $225million.


The TGA move follows the release earlier this month of a study by the Australian Adverse Drug Reactions Advisory Committee on the possible link between SSRIs and increased suicidal thoughts in adolescents.

Drawing on recent studies in Britain and the US, the report found there was evidence for the efficacy of fluoexetine (Prozac) and, possibly, citalopram (Cipramil) in major depressive disorder for children and adolescents, but not for other drugs in the group, including Aropax, Zoloft and Efexor.

The report found that data on the efficacy and safety of SSRIs with children and adolescents was not conclusive, but it issued strict guidelines for their prescription and warned against the use of certain drugs. The spokesperson for the TGA, which approves all medicines sold in Australia, said the body would seek more explicit labelling from drug companies.

A Sydney spokesman for US pharmaceutical giant Eli Lilly, which makes Prozac, said the company would consider any request for label changes and supported the careful monitoring by doctors of patients' responses to medication.

Bill Lyndon, who chairs the psychotropic drugs committee of the Royal Australian and New Zealand College of Psychiatrists, said he welcomed any move that raised awareness about SSRIs and encouraged caution.

"I'm aware of a link between SSRIs and suicidal thoughts in adults, as well as adolescents, but the evidence is not conclusive," Dr Lyndon said.

"These are valuable drugs, and it would be a disaster if people were to stop using them."

A spokeswoman for Medicines Australia, which represents the drug industry, said companies would take a responsible attitude.

"But they don't want to alarm consumers unduly and stop them taking medication," she said.

A drug industry source said that suicidal thoughts were sometimes a symptom of major depression rather than the side effect of a particular medication.

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