FDA probes Prozac, suicide link

December 31, 2004

UK journal sends regulator 'missing documents' related to clinical trials of

the antidepressant.

December 31, 2004: 6:32 AM EST

LONDON (Reuters) - The British Medical Journal (BMJ) said Friday it has sent

documents to U.S. health regulators that the journal said may suggest a link

between the antidepressant drug Prozac and suicidal behavior.

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. (Research)

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 the drug,

whose generic name is 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 (www.bmj.com), the journal

said it had sent the papers to the Food and Drug Administration.

It quoted the agency's Dr. 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. " Top of page

Recommended Posts