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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