Seroxat, known as Paxil in the US, is one of the world's most
widely used anti-depressants and had sales last year of £2bn
($3.3bn). Over the past year about 4m prescriptions for the drug
were written, with an estimated 8,000 patients being under 18.
The new advice to doctors came after a two-week review into
Seroxat and other anti-depressants by the government's Medicine's
and Healthcare Products Regulatory Agency.
The review - sparked by complaints of adverse reactions in
Seroxat patients - found an increase in the rate of self harm and
potentially suicidal behaviour in children and teenagers under
18.
"It has become clear that the benefits of Seroxat in children for
the treatment of depressive illnesses do not outweigh the risks,"
the agency said.
Seroxat is not currently licensed for use in children, but is
often prescribed to under 18s at their doctor's discretion.
"It is therefore important that doctors, patients and parents are
aware of the new advice," said Professor Gordon Duff, chairman of
the Committee on Safety on Medicines.
An expert group investigating SSRIs, the class of
anti-depressants known as selective serontonin retake inhibitors,
which include Prozac, will now be "examining urgently" the
implications of the new findings for Seroxat use in over 18s.
Richard Brook, chairman of the mental health charity MIND, which
raised the concerns of Seroxat users, said: "MIND strongly believes
that the decision today [Tuesday] requires us to move very quickly
forward on the review of Seroxat and other SSRIs, especially given
the strength of concern we've heard from people taking these
drugs."
Shares in GSK were 3p lower at £12.58 in late morning trade in
London.
