Company Eli Lily knew of Prozac's risks in 1980's

As reported in the British Medical Journal

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 Fluoxetine Clinical Trials," found that in clinical trials "38% of fluoxetine-treated patients reported new activation but 19% of placebo-treated patients also reported new activation yielding a difference of 19% attributable to fluoxetine."

The FDA recently issued a warning that antidepressants can cause a cluster of "activating" or stimulating symptoms such as agitation, panic attacks, insomnia, and aggressiveness. Dr Joseph Glenmullen, a Harvard psychiatrist and author of The Antidepressant Solution, published by Free Press, said it should come as little surprise that fluoxetine might cause serious behavioural disturbances, as it is similar to cocaine in its effects on serotonin.

The full report is freely available at the link.

As reported in the news elswhere:

The documents reportedly went missing in 1994, when relatives of victims of a workplace shooting in Kentucky sued Eli Lilly. Gunman Joseph Wesbecker, who killed eight people and himself in 1989, had been prescribed Prozac a month before the shootings.

The lawsuit alleged the company knew for years that an increase in violence can be one of the side-effects of Prozac.

Eli Lilly won the case, but later said it had settled with plaintiffs during the trial.

The journal said the documents, dated November 1998, reported that fluoxetine or Prozac had caused behavioural disturbances in clinical trials.

Dr. Richard Kalpit, the U.S. Food and Drug Administration reviewer who approved Prozac, said he was not given the company's data. "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 from the journal. The journal has turned the documents over to the FDA, which is reviewing them.

In the last six months, regulators in Canada and the U.S. have warned that antidepressants like Prozac, so-called selective serotonin reuptake inhibitors or SSRI antidepressants, can stimulate side-effects such as agitation, panic attacks, insomnia and aggressiveness.