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Internal document indicates Eli Lilly knew of possible Prozac risks years ago

January 3, 2005

An internal document from Eli Lilly and Co., maker of antidepressant medication Prozac (fluoxetine), has been made public and could greatly affect existing and future Prozac lawsuits.

The paper was titled "Activation and sedation in fluoxetine clinical trials," and authors said Prozac might produce nervousness, anxiety, agitation or insomnia in 19 percent of patients and sedation in 13 percent of patients.

The document indicates Eli Lilly had data more than 15 years ago showing patients taking Prozac were far more likely to attempt suicide and show hostility than patients taking other antidepressants, but that the company tried to minimize public knowledge of the effects.

The British Medical Journal reported on the 1988 document, as well as other documents, last week, and its editors said the documents had been reported missing from a 10-year-old murder case. The editors said they had sent the documents for review to the U.S. Food and Drug Administration.

In 1994, a case involving Joseph Wesbecker, a printing press operator who had killed eight people at his Louisville, Kentucky, workplace five years prior, was taking Prozac when he then shot and killed himself. Relatives contended in a civil suit against Eli Lilly that the company was aware of the Prozac side effects that could have played a role in Wesbecker's increased propensity to violence.

Eli Lilly eventually won the case, but was later forced to admit it had made a secret settlement with the plaintiffs during the trial, so the verdict was invalid. The four internal documents that were recently made public were all stamped "Confidential" and "Fentress," the name of one of Wesbecker's victims.

The document indicated 3.7 percent of the 14,198 patients taking Prozac in the clinical trials attempted suicide while taking Prozac, which is a rate more than 12 times that cited for any of four other commonly used antidepressants. The document also stated 2.3 percent of users suffered psychotic depression while taking Prozac, which is a rate more than double the next highest rate of patients using another antidepressant. In addition, 1.6 percent of patients reported incidents of hostility, which is more than double the rate reported by patients on any of the four other commonly used antidepressants.

Rep. Maurice Hinchey, D-New York, has called for tightening FDA regulations on drug safety and said in response to the internal documents that, "the case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA approved drugs so that patients and their doctors, not the drug companies, decide whether the benefits of taking a certain medicine outweigh the risks."

For more information on Prozac risks, please contact us to confer with a lawyer and learn your legal rights and options.

 

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