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Papers indicate firm knew possible Prozac suicide risk

By Tom Watkins

Mayo Clinic
Food and Drug Administration (FDA)
Eli Lilly and Company

(CNN) -- An internal document purportedly from Eli Lilly and Co. made public Monday appears to show that the drug maker had data more than 15 years ago showing that patients on its antidepressant Prozac were far more likely to attempt suicide and show hostility than were patients on other antidepressants and that the company attempted to minimize public awareness of the side effects.

The document was provided to CNN by the office of Rep. Maurice Hinchey, D-New York, who has called for tightening FDA regulations on drug safety.

"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," he said.

The 1988 document indicated that 3.7 percent of patients attempted suicide while on the blockbuster drug, a rate more than 12 times that cited for any of four other commonly used antidepressants.

The document, which cited clinical trials of 14,198 patients on fluoxetine -- the generic name for Prozac -- also stated that 2.3 percent of users suffered psychotic depression while on the drug, more than double the next-highest rate of patients using another antidepressant.

In addition, the paper said that 1.6 percent of patients reported incidents of hostility -- more than double the rate reported by patients on any of four other commonly used antidepressants.

The trials reviewed in the document said that 0.8 percent of users of Prozac reported causing an intentional injury -- eight times the rate associated with any of the other antidepressants.

In the paper, titled "Activation and sedation in fluoxetine clinical trials," the authors said that the drug may produce nervousness, anxiety, agitation or insomnia in 19 percent of patients, and sedation in 13 percent of patients.

The paper, apparently produced by the drug company's marketing department, said "several suggestions may be helpful in presenting this information to physicians," including emphasizing that more patients on another class of antidepressants stopped taking their drugs than did those on Prozac.

The existence of the document obtained by CNN and other documents was reported last week by the British Medical Journal. Its editors said the documents had been reported missing from a 10-year-old murder case, and that they had sent them to the U.S. Food and Drug Administration for review.

A spokesman for Lilly said his company was expecting the release of the purported internal documents, but that he could not comment on them until he had seen them.

The journal said the documents disappeared in 1994, during the case of Joseph Wesbecker, a printing press operator who had killed eight people at his Louisville, Kentucky, workplace five years before, while taking fluoxetine. He then shot and killed himself.

Each of the four pages of the paper obtained by CNN is stamped "Confidential" and "Fentress," the name of one of Wesbecker's victims.

In a civil suit against Eli Lilly, victims' relatives contended the company had long known about the side effects of fluoxetine, including its alleged role in increasing a user's propensity to violence.

Lilly initially won the case, but was later forced to admit that it had made a secret settlement with the plaintiffs during the trial, which meant that the verdict was invalid, the journal said.

The FDA has recently warned that antidepressants can cause side effects such as agitation, panic attacks, insomnia and aggressiveness.

FDA spokeswoman Susan Cruzan said last week that the agency had no comment on the documents.

In a statement posted on Lilly's Web site, the company said, "To our knowledge, there has never been any allegation of missing documents from the Wesbecker trial or any other trial involving Lilly. Further, it has always been Lilly's objective to publicly disclose data about both the safety and efficacy of fluoxetine.

"Lilly has made several requests to the BMJ to obtain copies of the supposed 'missing' documents; we still await these documents. We are surprised and concerned that a leading medical journal would not find it important to share these documents with us so that we could respond to the public in a meaningful way."

Based on its history of having provided regulatory authorities with study results, the statement said, "Lilly believes that there is no new scientific information to review on this topic."

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