Youth/Suicide/Prozac ....did the MHRA NOT have full trial data???

[Guest guest]

" .......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said: " We got all the published trials and the unpublished material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the full set [of unpublished trials], which in itself is worrying. "

Prozac is linked to child suicide in US ©2004 Independent Digital

(UK) Ltd.

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, " 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said: " We got all the published trials and the unpublished material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the full set [of unpublished trials], which in itself is worrying.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

, whose 13-year-old son killed himself after he started

treatment with Zoloft.

15 September 2004 10:48

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Printable Story

By nce and Usborne in New York

15 September 2004

http://news.independent.co.uk/uk/health_medical/story.jsp?

story=561811