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.
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