- LONDON -- A British medical
publication said Friday that it had given U.S. regulators confidential
drug company documents suggesting a link between the antidepressant Prozac
and a heightened risk of suicide attempts and violence.
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- The British Medical Journal reported in its latest issue
that documents it received from an anonymous source indicated that Prozac's
manufacturer, Eli Lilly and Co., was aware in the 1980s that the drug could
have potentially troubling side-effects.
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- The Indianapolis-based company's stock dipped 75 cents
a share to $56.75 on light afternoon trading Friday on the New York Stock
Exchange.
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- The journal said the documents, reportedly missing for
a decade, had formed part of a 1994 lawsuit against Eli Lilly on behalf
of victims of a workplace shooting in Louisville. Joseph Wesbecker, the
gunman who killed eight people and himself in 1989, had been prescribed
Prozac a month before the shootings.
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- Eli Lilly won the case but later disclosed that it had
reached a secret settlement with the plaintiffs during the trial.
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- The journal said that one of the records, dated November
1988, reported that fluoxetine, the generic name for Prozac, had caused
"behavioral disturbances" in clinical trials.
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- The journal said it had turned the documents over to
the U.S. Food and Drug Administration, which had agreed to review them.
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- The journal said the office of Rep. Maurice Hinchey (D-N.Y.)
also was examining the documents to determine whether Eli Lilly had withheld
data from the public and the FDA.
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- "This is an alarming study that should have been
shared with the public and the FDA from the get-go, not 16 years later,"
Hinchey was quoted as saying.
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- Lilly representatives said it had always been the company's
objective to disclose data about the safety and efficacy of Prozac.
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- "To our knowledge, there has never been any allegation
of missing documents from the Wesbecker trial or any other trial involving
Lilly," the company said Friday in a statement.
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- "Lilly has made several requests to the [British
Medical Journal] to obtain copies of the supposed `missing' documents;
we still await these documents," the company's statement said. "We
are surprised and concerned that a leading medical journal would not find
it important to share these documents with us so that we could respond
to the public in a meaningful way."
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- Lilly said it has consistently provided regulatory agencies
results from clinical trials and safety monitoring.
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- "Based on this, Lilly believes that there is no
new scientific information to review on this topic," the company's
statement said.
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- In an earlier statement issued to the British journal,
Lilly said Prozac "has helped to significantly improve millions of
lives."
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- "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," that statement said.
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- In October, the FDA ordered that all antidepressants
carry warnings that they "increase the risk of suicidal thinking and
behavior" in children.
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