Journal sends Prozac documents to U.S. regulator
Fri Dec 31, 2004 11:34 AM GMT
LONDON (Reuters) - The British Medical Journal says it has sent documents to U.S. health regulators which it says appear to suggest a link between antidepressant drug Prozac and suicidal behaviour. The journal said on Friday an anonymous source had given it "missing documents" relating to clinical trials of the drug, made by Indianapolis-based company Eli Lilly and Co.
The BMJ said the documents included reviews and memos which appeared to show Eli Lilly officials were aware in the 1980s that the drug, whose generic name is fluoxetine, had "troubling side effects".
In a copy of the article posted on its Web site (www.bmj.com), the journal said it had sent the papers to the U.S. Food and Drug Administration.
It reported the FDA's Dr Richard Kapit, a clinical reviewer who approved fluoxetine, as saying he had not been given the data highlighted in the documents.
"These data are very important," Kapit was quoted as saying. "If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it."
No one from Eli Lilly was immediately available to comment on the BMJ report.
The journal said the company released the following statement: "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 efficiency of Prozac is well studied, well documented and well established."
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