DOCUMENTS sent anonymously to the British Medical Journal suggest that in the 1980s the maker of Prozac, Eli Lilly, failed to disclose all it knew about the link between the antidepressant and the risk of violent or suicidal behaviour. The documents have been passed to the US Food and Drug Administration.
One of the documents, dated 8 November 1988, reports that during one trial 38 per cent of patients on Prozac experienced “activation”, a cluster of symptoms that includes agitation, panic attacks, insomnia and aggressiveness. “This is an alarming study that should have been shared with the public and the FDA from the get-go, not 16 years later,” says New York Congressman Maurice Hinchley, who is reviewing the documents to determine whether Eli Lilly withheld information from the public and FDA.
Eli Lilly says it has published “widely” on the links between Prozac and activation. It says the drug’s safety is “well established”.
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The BMJ claims that the documents went missing during a 1994 court case. In 1989, Joseph Wesbecker, a patient who had begun taking Prozac a month earlier, shot and killed eight people and wounded another 12 before committing suicide. Survivors and relatives sought damages from Eli Lilly. The jury found for the company, but the judge later dismissed the verdict as invalid after discovering that Eli Lilly had secretly settled with the plaintiffs during the trial.
