FDA probes Eli Lilly papers on Prozac

INDIANAPOLIS, Dec. 31 (UPI) -- U.S. regulators are reviewing documents from Eli Lilly for evidence its antidepressant, Prozac, may be linked to violence.

The British Medical Journal said internal company documents that had become part of a 1994 civil suit against the Indianapolis drugmaker had disappeared during the 10-year-old case. After recently receiving the documents through an anonymous sender, the British Medical Journal gave them to the U.S. Food and Drug Administration.

The lawsuit stems from a deadly 1989 shooting spree by a man who was taking Prozac, also known generically as fluoxetine.

Of particular interest is an article, dated Nov. 8, 1988, and titled "Activation and Sedation in Fluoxetine Clinical Trials," that found 38 percent of patients reported "new activation" -- symptoms of which include agitation and aggressiveness -- compared with 19 percent of placebo patients.

A spokesman for Eli Lilly said the company is "committed to the public disclosure of all clinical trial data to ensure that health-care professionals and families have all the information they need to make informed decisions about all of Lilly's medicines."