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Prozac is linked to child suicide in US

By Jeremy Laurance and David Usborne in New York

15 September 2004

The Government came under pressure yesterday to ban the use of the
antidepressant drug Prozac in children after US regulators warned that it
could increase the risk of suicide.

Prozac is the only antidepressant that doctors can prescribe to
children in Britain following a safety review last year. The drug was
singled out by the UK Medicines and Healthcare Products Regulatory
Authority (MHRA) as the only one of the modern generation of
antidepressants that was effective and safe in children. All others were
banned for children last December.

But US regulators claim there is nothing to distinguish the drugs,
known as selective serotonin uptake inhibitors (SSRIs) and all are risky
in children. "I think we now all believe that there is an increase in
suicidal thinking and action that is consistent across all the drugs,"
Robert Temple, the director of the Food and Drug Administration (FDA)
office of medical policy, said on Monday.

He was speaking at the first day of hearings in Washington on whether
antidepressants should have tougher warning labels. An advisory committee
of the FDA was expected to announce the new curbs last night after two
days of hearings. The curbs are likely to involve more explicit labelling
to discourage their distribution to young people, or an outright ban.

Disclosure of the US authorities' view that there were problems with
Prozac alarmed psychiatrists in Britain. Tim Kendall, head of research at
the Royal College of Psychiatrists, who published a survey of research on
antidepressants in children earlier this year, said: "We got all the
published trials and the unpublished material from the MHRA and we
couldn't find that. If the FDA has come up with something [in relation to
Prozac] it suggests the MHRA didn't have the full set [of unpublished
trials], which in itself is worrying."

Mike Shooter, president of the Royal College and a child psychiatrist,
said: "It is outrageous that any information about efficacy or side
effects should be kept from psychiatrists, patients or their carers. If we
are now getting information that both the efficacy has been overblown and
the side effects underplayed then basically we have all been cheated. It
undermines the therapeutic relationship."

The FDA analysis found the risk of suicide among patients given such
pills was small. Only two or three out of 100 became suicidal compared to
children who were given placebos. Of the few who did become suicidal, none
took their lives.

Relative risks of suicidal behaviour were highest among young people
taking Luvox, Effexor and Paxil and lower among those taking Celexa,
Zoloft and Prozac. The US is now playing catch-up with Britain, and the
delay in the FDA acknowledging the link between the drugs and suicidal
thoughts has angered parents who have lost children while on treatment.
"Why haven't parents been told the truth?" asked Mark Miller, whose
13-year-old son killed himself after he started treatment with Zoloft.

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