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FDA to review “missing” drug company documents

BMJ 2004; 330 doi: http://dx.doi.org/10.1136/bmj.330.7481.7 (Published 30 December 2004) Cite this as: BMJ 2004;330:7

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  1. Jeanne Lenzer
  1. New York

    The US Food and Drug Administration has agreed to review confidential drug company documents that went missing during a controversial product liability suit more than 10 years ago. The documents appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence.

    The missing documents, which were sent to the BMJ by an anonymous source last month, include reviews and memos indicating that Eli Lilly officials were aware in the 1980s that fluoxetine had troubling side effects and sought to minimise their likely negative effect on prescribing.

    The documents received by the BMJ reportedly went missing during the 1994 Wesbecker case that grew out of a lawsuit filed on behalf of victims of a work-place shooting in 1989. Joseph Wesbecker, armed with an AK-47, shot eight people dead and wounded another 12. He then shot and killed himself. Mr Wesbecker, who had a long history of depression, had been placed on fluoxetine one month before the shootings.

    One of the internal company documents, a report of 8 November 1988, entitled “Activation and Sedation in …

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