Documents Said to Show Prozac Risks
NY Times ^ | December 31, 2004 | REUTERS
LONDON, Friday, Dec. 31 (Reuters) - The British Medical Journal said on Friday it had sent documents to health regulators in the United States that it said appear to 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 Eli Lilly & Company.
It said the documents had been lost during a product liability suit in 1994. They included reviews and memos that appeared to show Eli Lilly officials were aware in the 1980's that the drug, whose generic name is fluoxetine, had "troubling side effects," the journal said.
Officials at Eli Lilly, which is based in Indianapolis, could not immediately be reached for comment on the report.
In an article appearing in its Jan. 1 issue, which it posted on its Web site at www.bmj.com on Friday, the journal said it had sent the papers to the Food and Drug Administration.
It quoted Dr. Richard Kapit of the F.D.A., a clinical reviewer who approved fluoxetine, as saying that he had not been given the data highlighted in the documents, and that they were "very important."
The journal said Lilly officials declined to be interviewed but issued a statement saying the safety and usefulness of Prozac were well established.
|
