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[e-drug] Antidepressants for children banned in the UK

E-drug: Antidepressants for children banned in the UK

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Threat of suicide leads to ban of major antidepressants for children

The Independent, London 10 December 2003
By Andrew Clennell

All major antidepressant drugs other than Prozac, known as
SSRIs, are set to be be banned for children under 18 by the
Government today, amid concerns that the drugs cause young
patients to commit suicide.

Sources at the Department of Health confirmed reports last night
that four antidepressant drugs would be banned for children. Two
drugs in the same group, Seroxat and Efexor, were banned in June
and September respectively. An announcement is expected in
Parliament today from the Medicines and Healthcare Products
Regulatory Agency (MHRA).

Doctors will be told not to prescribe Lustral (chemical name
setraline), Cipramil (citalopram), Cipralex (escitalopram) and
Faverin (fluvoxamine) to under-18s. Fifty thousand children are
estimated to be on antidepressants in Britain.

The MHRA was said to have told doctors last night they should not
prescribe any selective serotonin reuptake inhibitors (SSRIs), other
than Prozac. It will also warn that Prozac will help only one child
out of 10. However, the agency will say that patients already on
medication should not stop it suddenly, to avoid withdrawal

The decision comes after pressure from parents and campaigners.
Health authorities have never recommended use of the drugs by
under-18s but GPs have prescribed more and more for children.
The ban is likely to cause problems for doctors because there are
an insufficient number of counsellors and psychotherapists to deal
with mental health problems through alternative treatment -

The ban was reported, by The Guardian, to have come after
details of clinical trials of depressed children that were held by drug
companies in the late 1990s were studied by the MHRA. Efexor
was said to be used by about 3,000 adolescents when it was
banned in September.

Seroxat was said to have been prescribed to up to 8,000 children
by June and was used by 600,000 to 800,000 adults. It was
banned after research showed it could trigger suicidal thoughts
and thoughts of self-harm. The drug's maker, GlaxoSmithKline,
disagreed with the Government's decision at the time, saying it
would "limit the choices" available to doctors to treat depression.
The Government's SSRI review group would now look at the safety
and efficacy of the drugs in adults, it was reported last night.
Drug companies began trials on the safety of SSRIs in children
after US government pressure in the early 1990s. 


Drugs for depressed children banned

The Guardian, London 10 December 2003
By Sarah Boseley

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

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

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

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

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

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