The Medicines and Healthcare products Regulatory Authority (MHRA)
said new data received in the last two weeks showed an increase in
the rate of self-harm and potentially suicidal behaviors in this age
group when Seroxat was prescribed.
"It has become clear that the benefits of Seroxat in children for
the treatment of depressive illness do not outweigh these risks,"
the MHRA said in a statement.
Seroxat, known as Paxil in the United States, belongs to the same
class of SSRIs (Selective Serotonin Reuptake Inhibitors) as Eli
Lilly & Co's Prozac. It generated global sales of 2.06 billion
pounds ($3.40 billion) in 2002, of which some 100 pounds million was
sold in Britain.
But the medicine -- one of the world's best-selling
pharmaceuticals -- has been the subject of increased public concern
due to reports of adverse reactions, prompting Britain to set up an
expert panel to investigate.
Although only officially approved for adults, doctors have had
discretion to prescribe Seroxat to young people on a so-called
"off-label" basis. A total of four million prescriptions were
written for Seroxat in Britain last year, with around 8,000 patients
under 18 receiving treatment.
New data from various clinical trials showed episodes of
self-harm and potentially suicidal behavior were between 1.5 and 3.2
times higher in under-18s taking Seroxat than in those receiving a
placebo, or dummy, pill, the MHRA said.
Professor Alasdair Breckenridge, chairman of the MHRA, said there
would be an urgent examination of what implications, if any, the new
findings would have for the use of other SSRIs and Seroxat in
adults.
FDA (news
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Authorities in Ireland immediately followed the British lead,
while the U.S. Food and Drug Administration is evaluating the latest
data and Europe's CPMP expert committee on medicines has also been
alerted.
Company spokeswoman Mary Anne Rhyne said, however, GSK was still
pursuing an application to market Paxil in the U.S. for children
with obsessive compulsive disorder. Paxil is already licensed for
adults with the condition. As in Britain, it is also used off-label
for treating youngsters with depression.
Two years ago a Wyoming jury in the United States awarded $6.4
million to the family of a patient taking the drug who murdered his
wife, daughter and granddaughter and then committed suicide in what
the family said was a reaction to the drug.
And in March this year a British coroner asked for its withdrawal
pending more studies when a retired headteacher committed suicide
after taking Seroxat for a fortnight.
Britain's Royal College of Psychiatrists said it had been
concerned for many years about off-label prescribing of Seroxat and
welcomed the curbs on use in young people.
GSK insisted its drug was safe and effective but Alastair Benbow,
head of European psychiatry, said the group would work to implement
the changes as soon as possible.
June Raine, who supervises drugs already on the market, said the
MHRA was introducing a new system to evaluate how companies
monitored risks associated with their products and would consider
including GSK in the process.
The new restrictions on Seroxat had been expected, after sources
said on Monday Britain was preparing to update safety guidelines,
focusing on potential problems among under-18s.
GSK shares slipped 0.6 percent to 12.54 pounds by 1505 GMT,
behind the European sector, up 0.2 percent.
Lehman Brothers analyst Matthew Weston said the financial impact
was limited, since under-18 use accounted for less than one percent
of UK prescriptions. In the U.S., pediatric use of Paxil represents
a "low single digit" percentage of total sales. ($1=.6064 Pound)
