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[e-drug] Antidepressants for children banned in the UK (cont'd)

E-drug: Antidepressants for children banned in the UK (cont'd)

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Rules on medicines 'need big shake-up:' Anti-depressant ban for
children reveals flaws in system, says Mind

The Guardian, London, 11 December 2003
By Sarah Boseley, health editor

There were calls yesterday for an independent review of the
regulation of drugs in the UK, following the banning of most
modern anti-depressants from use in children some years after
pharmaceutical company trials showed up a problem. Mind, the
leading mental health charity, said the regulatory process was
fundamentally flawed and needed to be overhauled if consumers
were to have any confidence in it.

"It is totally unacceptable that for a significant period 50,000
children and adolescents in the UK have been prescribed
anti-depressant drugs that were not licensed for use but it is only
now being demonstrated that they do not help and can indeed
cause harm," said Richard Brook, Mind's chief executive.

"The loud voices of users and a high profile campaign started a
course of events that led to [Tuesday's] announcement. Long-term,
effective and strong regulation has not been evident or provided
the type of information consumers have the right to expect."

As the Guardian revealed yesterday, four antidepressants of the
selective serotonin reuptake inhibitor (SSRI) class were effectively
banned from use in children by the Medicines and Healthcare
Products Regulatory Agency: Lustral (known as Zoloft in the USA),
Cipramil, Cipralex and Faverin. Two others, Seroxat and Efexor,
were banned earlier this year. None was licensed for use in
children, but doctors can prescribe unlicensed drugs if they feel it
is appropriate.

The MHRA reached its decision after an expert working group
reviewing the SSRI class of drugs was given access this year to
the full trial results of some in children. Although these were
carried out in the mid to late-1990s, the full data had not been
given to the MHRA. These showed that more children and
adolescents became suicidal on the drugs than on placebos (sugar

The review of the SSRIs was only set up at the end of last year
because of mounting public pressure, following allegations that
people became hooked - unable to stop taking them without
suffering severe withdrawal effects - and in some cases suicidal.

"There are enormous commercial interests trying to influence
decisions about the use of drugs," said Mr Brook. "Pharmaceutical
companies represent the second largest industry in the UK. The
public needs to have confidence that their health is being properly
protected - particularly where children are concerned."

The companies are not happy with the MHRA ruling. Pfizer, which
manufactures Lustral, said in a statement: "Pfizer disagrees with
this guidance based on a thorough review of our clinical trial
database ... Pfizer believes that the robust clinical programme
involving sertraline suggests no increased risk of harm to any
population, including children and adolescents."

One drug from the SSRI class, Prozac, has not been banned, but
the psychopharmacologist whose researches started the concerns
over suicides said yesterday that the trial data in children did not
show it was superior in safety or efficacy to the others. David
Healy, director of the North Wales department of psychological
medicine, said there had been two trials of Prozac in children - one
reported in 1997 and the second in 2002. The drug's performance
in the first showed little effect.

In the second trial, however, although Prozac did not lift children's
depression more effectively than the other SSRIs, it scored better
because the children in the comparison placebo group did not do
as well as in trials of other drugs.

And yet, said Dr Healy, "the adverse event [side effect] profile was
worse on Prozac than on placebo. In the Prozac group of trials
there were four suicidal acts among children and zero on placebo."

There is some concern now that children on SSRIs will be switched
by doctors to Prozac, when the best alternative for most would be
non-drug therapy. Mind said yesterday, however, that there is a
shortage of professionals trained in other approaches which can
help in depression. Mind and the MHRA say it is important for
children on SSRIs not to stop taking them suddenly, but to consult
their doctor.

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