LONDON - A medical journal has given U.S. regulators confidential drug company documents suggesting a link between the antidepressant Prozac and a heightened risk of suicide attempts.
Documents from an anonymous source indicate Prozac's manufacturer, Eli Lilly & Co., was aware of the drug's potential side-effects in the 1980s, the British Medical Journal said in its Jan. 1 issue.
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.
Eli Lilly said the "safety and efficiency of Prozac is well studied, well documented, and well established."
