UK journal sends Prozac documents to US regulator

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The British Medical Journal (BMJ) said on Friday it has sent documents to U.S. health regulators that it said appear to suggest a link between the antidepressant drug Prozac and suicidal behaviour.

The journal said an anonymous source had provided “missing documents” relating to clinical trials of the drug, made by Indianapolis-based drugmaker Eli Lilly and Co.

The BMJ said the documents “went missing during a controversial product liability suit more than 10 years ago.” They included reviews and memos that appeared to show Eli Lilly officials were aware in the 1980s that Prozac (fluoxetine) had “troubling side effects,” it said.

Eli Lilly officials could not immediately be reached for comment on the BMJ report.

In a copy of the article posted on its Web site (http://www.bmj.com ), the journal said it had sent the papers to the U.S. Food and Drug Administration.

It quoted the agency’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.”

The journal said the company declined to be interviewed but issued a written statement that 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.”

SOURCE: British Medical Journal, January 1, 2005.
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PROZAC ® (fluoxetine hydrochloride) is used to treat depression, bulimia, obsessive compulsive disorders (OCD) and severe symptoms of premenstrual syndrome (PMDD). Prozac works by helping to restore the balance of certain natural chemicals in the brain.

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