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Secret Prozac danger reports go to US.

CONFIDENTIAL drug company documents appearing to suggest a link between a popular antidepressant and suicide attempts and violence have been handed to US authorities.

The British Medical Journal (BMJ) received the documents concerning the drug fluoxetine (Prozac) from an anonymous source and has now turned them over to the US Food and Drug Administration (FDA).

The makers of Prozac, pharmaceutical firm Eli Lilly - which has a large base in Speke, Liverpool - are robustly defending the drug.

In 1994, some of the relatives of the victims of a man who carried out a workplace shooting - who had been put on Prozac a month before - brought a civil suit against Eli Lilly.

They alleged that the company had known about the side-effects of the drug - including the fact it might increase violence - for years.

Although the company won the case, it was later forced to admit that it had made a secret settlement with the plaintiffs during the trial, making the verdict invalid.

The documents sent to the BMJ include reviews and memos indicating that Eli Lilly officials were aware in the 1980s that Prozac had troubling side-effects and sought to minimise their likely negative effect on prescribing.

Dr Richard Kapit, the FDA clinical reviewer who approved Prozac, told the BMJ that he was not given the Lilly data.

``This data is very important. If this report was done by Lilly, or for Lilly, it was their responsibility to report it to us and to publish it, '' he said.

In a statement to the BMJ, Lilly said: ``Prozac has helped to significantly improve millions of lives. It is one of the most studied drugs in the history of medicine, and has been prescribed for more than 50m people worldwide.

``The safety and efficacy of Prozac is well studied, well documented and well established. ''
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Publication:Daily Post (Liverpool, England)
Date:Dec 31, 2004
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