Summary

Original source:
http://www.usatoday.com/news/health/2004-12-31-prozac-risks_x.htm

Details

• A British medical journal said Friday that 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 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 The gunman who killed eight people and himself in 1989, Joseph Wesbecker, had been prescribed Prozac a month before the shootings.
• 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.
• The journal said the office of Congressman Maurice Hinchey, D-N.Y., also was examining the documents to determine whether Eli Lilly had withheld data from the public and the FDA.
• "This is an alarming study that should have been shared with the public and the FDA from the get-go, not 16 years later," Hinchey was quoted as saying.
• In a statement to the journal, Eli Lilly said Prozac "has helped to significantly improve millions of lives."
• "It is one of the most studied drugs in the history of medicine and has been prescribed for more than 50 million people worldwide.
• The safety and efficacy of Prozac is well studied, well documented and well established."
• In October, FDA ordered that all antidepressants carry warnings that they "increase the risk of suicidal thinking and behavior" in children.

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