- (Note: Seroxat is sold as Paxil in the US. -ed)
-
- The modern antidepressant drugs which were thought to
be a miracle cure for 20th century misery only 10 years ago are expected
to suffer a second big blow this year when the UK authorities will warn
that some of them can cause adults to become suicidal.
-
- An expert working group of the government's Committee
on the Safety of Medicine (CSM) has already warned that all but one of
the SSRIs (selective serotonin reuptake inhibitors), including the best-selling
Seroxat, should not be given to children. It found that there were risks
of children becoming suicidal, aggressive and suffering mood swings, and
the drugs were anyway not very effective.
-
- Now the committee is close to completing its review of
the safety and efficacy of the SSRIs in adults. The Guardian understands
that it has found a similar picture and that the drug regulatory body,
the Medicines and Healthcare Products Regulatory Agency (MHRA) is likely
to impose restrictions on the use of some of them.
-
- The decision will lead to further confusion and uncertainty
among doctors treating depression. Child psychiatrists and GPs have shown
conflicting reactions to the SSRI ban - some of them continuing to use
the drugs, while others hold off. Guidelines from the National Institute
for Clinical Excellence (Nice) on treating depression in adults were due
to be published this month, but have been postponed pending the MHRA announcement.
Guidelines on treating children are not due until next year.
-
- "With our colleagues it is very difficult,"
said Sue Bailey, chair of the child and adolescent faculty of the Royal
College of Psychiatrists. "They don't know whether they can or can't,
should or shouldn't prescribe."
-
- Two to 6% of children suffer from depression, and suicide
is the third leading cause of death in 10-to-19-year-olds, says Professor
Bailey. An estimated 40,000 children were on SSRIs last year.
-
- The college has asked the expert group to give "plain
English" advice as to what doctors should do, but they have been told
they must wait until the MHRA has met to discuss the issues with the European
drug regulators. It is well-known that the authorities in some parts of
Europe would like the MHRA to tone down the SSRI ban, but Professor Bailey
says she finds it hard to see how the MHRA can recant. "It is hard
to row back on the data they have shown us," she said.
-
- A conference on the issues around ensuring medicines
are safe for children is taking place today, with contributions from Lord
Warner, the health minister responsible, and Sir Alasdair Breckenridge,
chair of the MHRA.
-
- Yet the biggest problem in children's medication today,
the SSRIs, is not on the agenda. In a presentation next month, Prof Bailey
will call for government and other involved bodies to ensure children have
"the same rights to rigorously conducted research programmes"
as adults. She points out that the studies of depressed children so far
involve some as young as three, in whom depression has to be very carefully
diagnosed, using specially trained researchers.
-
- One SSRI has not been banned for use in children - Prozac,
which has a licence to treat children's depression in the United States.
Yesterday the manufacturer, Eli Lilly, told the Guardian it had been asked
by the MHRA to apply for a licence to treat children with depression in
the UK and Europe.
-
- Richard Brook, chief executive of the mental health charity
Mind, who resigned from the expert group on SSRIs because of what he claimed
was a lack of openness and transparency, said he was appalled that the
MHRA which polices the drug companies should approach one of them to suggest
it applies for a licence.
-
- "This raises real issues about their impartiality,"
he said. "They are saying they want an SSRI to be given to children.
It is not their job to decide such a thing. If they are going to do deals
with the drug companies, where does it stop? This is a fundamental breach
that the minister must investigate."
-
- Vera Sharaz, from the Alliance for Human Research Protection
in the United States, says it is astonishing that Prozac ever got a licence
there for use in children, adding that documents from the Food and Drug
Administration (FDA) which licensed it show that the first of two studies
done, in 1997, failed to reach the target Eli Lilly had set for benefiting
children and the second, in 2002, produced serious side-effects, including
growth retardation and heart problems.
-
- "Given the concern about evidence of a suicide link
to Prozac and the other antidepressants, it is an affront to the public
that the MHRA would even consider approving Prozac for children,"
she said. Eli Lilly in fact changed the label on the drug in the UK last
December to state: not recommended for children.
-
- Guardian Unlimited © Guardian Newspapers Limited
2004 http://www.guardian.co.uk/medicine/story/0,11381,1238131,00.html
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