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Company 'held
back' data on SSRI anti-depressants for children
February
8, 2004
The
Guardian newspaper has reported that British manufacturers of the
SSRI antidepressant, Seroxat, that was last year banned for children,
knew in 1998 that it was not effective.
The
newspaper said that the company deliberately avoided publishing
the full data because of the risk to their lucrative adult market.
This was according to a leaked internal document.
The
Guardian
wrote that a position paper dated October 1998 shows that managers
at SmithKline Beecham - now GlaxoSmithKline (GSK) - were concerned
at the commercial implications of two clinical trials in which their
drug Seroxat was given to children and adolescents with major depression.
However,
Alastair Benbow, GSK's head of European clinical psychiatry, was
quoted as saying that the document "draws inappropriate conclusions
and it is inconsistent with the facts".
Meanwhile
the British
Medical Journal reported that in the United States scientific
advisers to the Food and Drug Administration urged the agency to
warn that SSRIs may increase the risk of suicidal thinking or behaviour
among children and teenagers.
The
BMJ
reported that experts weighed the official presentations of uncertain
scientific data against powerful emotional testimony from dozens
of families whose children have killed themselves or others after
taking SSRIs — a class including fluoxetine (Prozac), sertraline
(Zoloft), and paroxetine (Paxil, Seroxat).
The
advisers also decided to recommend "stronger warnings"
about the suicide risks.
In
2002 almost 11 million prescriptions of selective serotonin reuptake
inhibitors were written for people under 18, including more than
five million for sertraline and paroxetine—neither of which
are approved for children in the United States.
See also:
Dec, 2003:
Medicines and Healthcare products Regulatory Agency's advice on
SSRIs and children sent to psychiatrists and other mental health
professionals (pdf)
Dec
14, 2003: Agency rules that SSRIs should not be prescribed for children
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