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Warning Issued Against Using Effexor in
Children
by Sarah Boseley,
The
Guardian, September 20, 2003
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visit
https://www.bridges4kids.org.
An
antidepressant which GPs [General Practitioners] have been
prescribing to thousands of children, in spite of the fact that
it is not recommended for their use, can cause youngsters to
want to kill themselves, the government's regulatory agency
warned yesterday.
Effexor, made by the drug company Wyeth, is being taken by at
least 3,000 children in the UK, it was revealed yesterday, even
though guidance to doctors states that it should not be given to
under 18s. It is the second antidepressant to be specifically
banned from use in children in four months.
There are around 50,000 children, some as young as six, on
antidepressants in the UK, the Guardian has learned. Last year,
doctors wrote 170,000 prescriptions of the drugs for children
under 18, even though many experts say counseling and talking
therapies work better.
Just as with Seroxat, the GlaxoSmithKline drug banned in June,
studies have shown that Effexor can cause children to have
suicidal thoughts or to become hostile, a word which in the
context of clinical trials can mean homicidal. Experts at the
Medicines and Healthcare Regulatory Agency (MHRA), which
licenses drugs in the UK, are urging that children should not
stop taking either drug suddenly, but should consult their
doctor.
The announcement raises a number of serious and urgent questions
about the conduct of the pharmaceutical industry, the use of
drugs in children and the ability of the MHRA to police the drug
companies and safeguard public health.
"We want to see urgent action to question how drugs are
regulated and licensed and how clinical trials are carried out
and reported as part of this process," said Richard Brook, chief
executive of Mind, the mental health charity.
Data which suggests the drugs could be causing children to feel
murderous and suicidal has been in drug company hands for
several years. The studies in these two drugs and others were
carried out in the mid to late-1990s, after the Food and Drug
Administration in the United States asked for efficacy and
safety data be cause of the rapidly increasing number of
children being prescribed antidepressants.
Glaxo is already under investigation by the UK regulators for
failing to hand over data showing the suicide risks earlier. One
of Wyeth's four studies in depressed and anxious children was
published in 1997. Yesterday a spokesman for the company refused
to give the dates of the other unpublished trials. Everything
that it was necessary for the public to know was in the public
domain, he said. "I'm not going to give additional information
to you."
The MHRA, which has a duty to police the companies, only
realized there were risks to children after it set up a working
group to review the antidepressants this year in response to
public concern over Seroxat in adults. It has now become
apparent that MHRA officials normally scrutinize only a summary
of the trial results that they are offered by the manufacturers,
and then only when the company is seeking a license.
Seroxat belongs to a class known as the SSRIs (selective
serotonin reuptake inhibitors), of which the best known is
Prozac. Effexor is closely related to that class - at the dose
prescribed by GPs it works in exactly the same way. None is
licensed for children. Doctors are entitled to prescribe drugs
"off label" - outside the license terms; in the case of
children, because trials have not been done, they often have no
choice.
"The expert group will be examining urgently what implications,
if any, these new findings have for other antidepressants," said
Professor Ian Weller, the review chairman.
David Healy, an expert in psychiatric drugs and director of the
North Wales department of psychological medicine, said he
thought up to 100,000 children could have been on SSRIs in the
last few years. "With rates of serious side effects in the
region of 2-3%, you are looking at a lot of kids who may have
been suicidal in one way or another, who would not have been if
they hadn't been put on these drugs."
Code words in trials can encompass a broad range of side
effects. In GlaxoSmithKline's study by Keller and colleagues,
carried out in 1995-6, 11 children suffered serious side
effects, compared with two taking a placebo [dummy pill]. The 11
were said to have suffered "various psychiatric events". Five
suffered "emotional lability" - a code word which embraced not
only a propensity for mood swings but also suicidal thoughts.
Seven children on Seroxat were hospitalized, including two with
emotional lability.
The Keller study was not published until 2001. Glaxo maintains
there was "no signal" that there were dangers with the drug
until two further studies were done. The combined data,
re-analyzed to look beyond "emotional lability" specifically at
suicidal thoughts and gestures, found that the drug did not work
in depression in children and that suicidal thoughts, self-harm
and gestures occurred in 3.2% of patients compared to 1.5% on
placebo.
In a statement to the Guardian, the MHRA tacitly acknowledged
that code words like "emotional lability" were unhelpful. "By
the time the totality of the data were submitted to the MHRA in
May [2003], the events listed under the overall term of
emotional lability had been analyzed to identify the individual
cases of potentially suicidal behavior and self-harm. Any high
level grouping of terms potentially decreases the sensitivity of
analyses."
"From reading the published material," said Dr Healy, "my
conclusion is that emotional lability has almost always meant
suicidality of one sort or another."
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