http://www.guardian.co.uk/uk_news/story/0,3604,1103563,00.html
THE GUARDIAN
Drugs for depressed children banned
Sarah Boseley, health editor
Wednesday December 10, 2003
The Guardian
Modern antidepressant drugs which have made billions for the
pharmaceutical industry will be banned from use in children today
because of evidence, suppressed for years, that they can cause young
patients to become suicidal.
The Medicines and Healthcare Products Regulatory Agency (MHRA) told
doctors last night not to prescribe all but one of the antidepressants known as
selective serotonin reuptake inhibitors (SSRIs).
The exception is Prozac, which is licensed for use in depressed children
in the US. But the MHRA will warn that, at best, it helps only one child in
10.
The decision has big implications for drug regulation.
The agency - which is the government's watchdog body on drug safety - has
reached this point only after intense pressure from patients and
campaigners.
They were concerned about patients - at first mainly adults - who appeared
to have become suicidal on the drugs, and others who had got hooked and
suffered distressing symptoms when they tried to stop taking them.
Public unease about these potential side-effects prompted the agency to
investigate last year. It has looked at the details of clinical trials of
depressed children that were in the hands of the drug companies in the
late 1990s. These studies revealed the problem of suicidal behaviour in
children, but the companies did not draw it to the attention of the regulators in
the US or the UK.
It has become clear from the investigation that the regulators generally
see only a summary of the data resulting from trials. It is prepared for them
by the drug company only when it is seeking a licence.
The agency became aware of a problem with Seroxat in children this year
only when the manufacturer, GlaxoSmithKline, submitted data from trials which
finished in 1996.
Pressure for a change in the regulatory system will inevitably grow.
Two of the SSRI class of drugs have already been banned - or, technically,
contra-indicated in children - by the agency.
The first, in June, was Seroxat, which goes by the generic name
paroxetine; the second, in September, was Efexor (venlafaxine); joining them now will
be Lustral (sertraline), Cipramil (citalopram), Cipralex (escitalopram) and
Faverin (fluvoxamine).
Trials on children have not been carried out in all the drugs, but the
completed studies show a worrying increase in suicidal behaviour among
those on SSRIs compared with those given a placebo (sugar pill).
None of the drugs has a licence for use in children with depression in the
UK, but GPs have prescribed more and more SSRIs for children.
It is estimated that as many as 50,000 children on antidepressants in
Britain.
The agency will warn that patients should not stop their medication
suddenly to avoid withdrawal symptoms.
The ban will cause problems for doctors because insufficient counsellors
and psychotherapists are available to offer the alternative treatment of
therapy, and the bill to the NHS for such treatment would be much higher
than the cost of the drug prescriptions.
Drug companies began clinical trials on the safety and efficacy of the
SSRIs in children only after prompting by the US food and drug administration in
the early 90s.
David Healy, the director of the North Wales department of psychological
medicine, said: "It was standard practice for the FDA approving drugs like
Seroxat (Paxil in the US) for adults in 1991 to write to the company and
say this drug will also be used in children - it would be helpful if you could
run trials in children so we can see what the safety profile is."
But trials that did not produce favourable results were neither published
nor sent to the FDA or the MHRA.
The first major Seroxat trial in children was finished by 1996, but the
results were not published until 2001. Data was also gathered in 1996
after a trial of Lustral, manufactured by Pfizer, showing that 9% of depressed
children on the drug became suicidal.
Dr Healy, whose own researches led to the establishment of the SSRI
review, said yesterday: "They should have known by 1996 that there was a problem.
GSK and Pfizer were asked to do this by the regulators so that we knew
what the safety issues were."
The drug companies dispute that a problem exists. Only a tiny minority of
children taking the drug become suicidal and their depression could be the
real cause, they claim. GSK says several trials, not just one, were needed
to establish whether its drug caused problems.
The SSRI review group, which has advised the Committee on the Safety of
Medicines of the agency to ban the drugs from use in children, will now
look at the safety and efficacy of the drugs in adults.s of the agency to ban
the drugs from use in children, will now look at the safety and efficacy of the
drugs in adults.
