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 UK
Paxil Banned in UK for under-18s
Mood drug Seroxat banned for under-18s (Seroxat
is the non-U.S. name for Paxil)
by Sarah Bosley, The Guardian (London), June 11, 2003
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The future of Britain's best-selling antidepressant drug,
Seroxat, and the rest of the class which includes Prozac, was in
question last night after drug regulators banned its use in
under-18s.
New evidence handed to the medicines and healthcare products
regulatory agency (MHRA), which licenses and monitors drugs, by
Seroxat's manufacturer, GlaxoSmithKline, demonstrated that it
can cause young people to become suicidal.
In trials, 3.4% of children on the drug experienced mood
changes, tried to harm themselves or thought of committing
suicide, compared with 1.2% on placebo pills. Some of the data
came from studies completed in the late 1990s, and the regulator
is unhappy Glaxo has not felt the need to pass it on until now.
There were 4m prescriptions written for Seroxat last year. It is
considered one of the wonder drugs of modern times and has been
handed out for shyness and compulsive disorders as well as for
anxiety and depression.
But doctors were told that yesterday that children must no
longer be given it. The 8,000 now on it must not stop suddenly,
experts warned, because of potential side-effects, but should
see their doctors. GPs will be advised to arrange counseling for
young people instead, even though it is expensive and in short
supply on the NHS.
The MHRA announcement was a swift and unexpected response to
clinical trial data handed over by the British drug giant Glaxo
just two weeks ago. The company gave the agency a meta-analysis
of nine separate studies of the drug in children and young
people which it had commissioned since the late 90s. Only one
had been published.
The studies were designed to gather information on the efficacy
and safety of Seroxat in children with three different illnesses
- major depression, social anxiety disorder and obsessive
compulsive disorder - in the hope of winning a license to market
the drug for those conditions in the US and Europe. At the
moment Seroxat is unlicensed for children, but doctors may and
do prescribe it to under-18s on their own authority.
According to Alastair Benbow, Glaxo's head of European
psychiatry, the trials on a total of 1,697 under-18s found that
the drug was effective for social anxiety disorder and obsessive
compulsive disorder, but not for depression.
He said the company had submitted the analysis of the nine
trials to the MHRA as a matter of routine. It had not supplied
the results of each trial as it finished. "We provide
information as a package," he said.
There had not been a clear signal from any one trial that there
might be a problem, he said, and so there was no reason to give
the MHRA earlier information.
"Not unless we think there is something that needs attention,
and we did not," Dr Benbow said. He added that Glaxo did not
agree with the MHRA's interpretation of the data, and insisted
there was no evidence the drug could make adults suicidal.
But an expert working group was set up by the MHRA this year to
look at the possible side-effects of all the drugs in this
class, known as the selective serotonin re-uptake inhibitors.
At an MHRA briefing yesterday its chairman, Alastair
Breckenridge, said the group would "urgently examine what are
the implications if any of these new findings in children and
adolescents for the use of Seroxat in adults, and what are the
implications for the other SSRIs."
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