From: Subject: News Date: Wed, 15 Sep 2004 21:44:42 +0200 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_0000_01C49B6D.35870C40"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2800.1441 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C49B6D.35870C40 Content-Type: text/html; charset="utf-8" Content-Transfer-Encoding: quoted-printable Content-Location: http://news.independent.co.uk/uk/health_medical/story.jsp?story=561811 =EF=BB=BF News

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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=20 antidepressant drug Prozac in children after US regulators warned = that it=20 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=20 singled out by the UK Medicines and Healthcare Products Regulatory = Authority (MHRA) as the only one of the modern generation of=20 antidepressants that was effective and safe in children. All = others were=20 banned for children last December.

But US regulators claim there is nothing to distinguish the = drugs,=20 known as selective serotonin uptake inhibitors (SSRIs) and all are = risky=20 in children. "I think we now all believe that there is an increase = in=20 suicidal thinking and action that is consistent across all the = drugs,"=20 Robert Temple, the director of the Food and Drug Administration = (FDA)=20 office of medical policy, said on Monday.

He was speaking at the first day of hearings in Washington on = whether=20 antidepressants should have tougher warning labels. An advisory = committee=20 of the FDA was expected to announce the new curbs last night after = two=20 days of hearings. The curbs are likely to involve more explicit = labelling=20 to discourage their distribution to young people, or an outright = ban.

Disclosure of the US authorities' view that there were problems = with=20 Prozac alarmed psychiatrists in Britain. Tim Kendall, head of = research at=20 the Royal College of Psychiatrists, who published a survey of = research on=20 antidepressants in children earlier this year, said: "We got all = the=20 published trials and the unpublished material from the MHRA and we = couldn't find that.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=20 Prozac] it suggests the MHRA didn't have the full set [of = unpublished=20 trials], which in itself is worrying."

Mike Shooter, president of the Royal College and a child = psychiatrist,=20 said: "It is outrageous that any information about efficacy or = side=20 effects should be kept from psychiatrists, patients or their = carers. If we=20 are now getting information that both the efficacy has been = overblown and=20 the side effects underplayed then basically we have all been = cheated. It=20 undermines the therapeutic relationship."

The FDA analysis found the risk of suicide among patients given = such=20 pills was small. Only two or three out of 100 became suicidal = compared to=20 children who were given placebos. Of the few who did become = suicidal, none=20 took their lives.

Relative risks of suicidal behaviour were highest among young = people=20 taking Luvox, Effexor and Paxil and lower among those taking = Celexa,=20 Zoloft and Prozac. The US is now playing catch-up with Britain, = and the=20 delay in the FDA acknowledging the link between the drugs and = suicidal=20 thoughts has angered parents who have lost children while on = treatment.=20 "Why haven't parents been told the truth?" asked Mark Miller, = whose=20 13-year-old son killed himself after he started treatment with = Zoloft.=20

=20

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