Journal: Prozac Side Effects Were KnownJan 3, 2005 | AP
A British medical journal said it had given U.S. regulators confidential drug company documents suggesting a link between the popular anti-depressant Prozac and a heightened risk of suicide attempts and violence.
The British Medical Journal reported in its Jan. 1 issue that documents it received from an anonymous source indicated that Prozac's manufacturer, Eli Lilly & Co., was aware in the 1980s that the drug could have potentially troubling side effects.
The journal said the documents, reportedly missing for a decade, had formed part of a 1994 lawsuit against Eli Lilly on behalf of victims of a workplace shooting in Louisville, Ky. Joseph Wesbecker, the gunman who killed eight people and himself in 1989, had been prescribed Prozac a month before the shootings.
Eli Lilly won the case, but later disclosed it had settled with the plaintiffs during the trial.
The journal said one of the records, dated November 1988, reported that fluoxetine, the generic name for Prozac, had caused "behavioral disturbances" in clinical trials.
The journal said it had turned the documents over to the U.S. Food and Drug Administration, which had agreed to review them.
"To our knowledge, there has never been any allegation of missing documents from the Wesbecker trial or any other trial involving Lilly," the company said in a statement. Lilly said it has always been its objective to disclose data about the safety and efficacy of Prozac.
"Lilly has made several requests to the BMJ to obtain copies of the supposed 'missing' documents; we still await these documents," the statement said. "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."
The company said it has consistently provided regulatory agencies with results from both clinical trials and safety monitoring after the drug was approved.
In October, FDA ordered that all anti-depressants carry warnings that they "increase the risk of suicidal thinking and behavior" in children.