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Prozac is linked to child suicide in US

London Independent | September 15 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a survey of research on antidepressants in children earlier this year, said: "We got all the published trials and the unpublished material from the MHRA and we couldn't find that. If the FDA has come up with something [in relation to Prozac] it suggests the MHRA didn't have the full set [of unpublished trials], which in itself is worrying."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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