Post by Mech on Jan 1, 2005 1:32:31 GMT -5
Journal Tells FDA Lilly Knew of Prozac Risk
Fri Dec 31, 6:02 PM ET
LONDON (Reuters) - The British Medical Journal said on Friday it has sent documents to U.S. health regulators that appear to suggest a link between the antidepressant Prozac and suicidal behavior.
In its Jan. 1 issue, the journal said an anonymous source had provided "missing documents" that included reviews and memos appearing to show that officials at Eli Lilly and Co., the drug's maker, knew in the 1980s that it had "troubling side effects."
The medical journal said the documents relating to clinical trials of fluoxetine, the generic name for Prozac, "went missing during a controversial product liability suit more than 10 years ago."
Indianapolis-based Lilly said in a statement that it has always sought to publicly disclose data and there has never been any allegation that documents were missing from the product liability trial brought by victims of Joseph Wesbecker or any other case.
Wesbecker in 1989 killed eight and wounded 12 before killing himself at a Louisville printing plant where he had been an employee. At the time, the 47-year-old was taking several medications, including Prozac. A jury found the company not liable, but Lilly had settled for an undisclosed amount with plaintiffs before the verdict was returned.
The company said it is still awaiting a response from the British journal to its request for copies of the documents.
Lilly said the article addresses "activation syndrome," a topic on which it has published widely and it believes "there is no new scientific information to review."
The theory is that antidepressants can increase the brain chemicals that give depressed people energy, making some patients feel "activated" and symptoms such as anxiety, irritability and hostility can worsen.
In a copy of the article posted on its Web site (www.bmj.com), the British 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.
The FDA in October ordered makers of antidepressants, including Prozac, to put tough warnings on the drugs that they increase the risk of suicidal behavior among children and teens.
"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 ... The safety and efficacy of Prozac is well studied, well documented and well established."
(Additional reporting by Deena Beasley in Los Angeles)
Fri Dec 31, 6:02 PM ET
LONDON (Reuters) - The British Medical Journal said on Friday it has sent documents to U.S. health regulators that appear to suggest a link between the antidepressant Prozac and suicidal behavior.
In its Jan. 1 issue, the journal said an anonymous source had provided "missing documents" that included reviews and memos appearing to show that officials at Eli Lilly and Co., the drug's maker, knew in the 1980s that it had "troubling side effects."
The medical journal said the documents relating to clinical trials of fluoxetine, the generic name for Prozac, "went missing during a controversial product liability suit more than 10 years ago."
Indianapolis-based Lilly said in a statement that it has always sought to publicly disclose data and there has never been any allegation that documents were missing from the product liability trial brought by victims of Joseph Wesbecker or any other case.
Wesbecker in 1989 killed eight and wounded 12 before killing himself at a Louisville printing plant where he had been an employee. At the time, the 47-year-old was taking several medications, including Prozac. A jury found the company not liable, but Lilly had settled for an undisclosed amount with plaintiffs before the verdict was returned.
The company said it is still awaiting a response from the British journal to its request for copies of the documents.
Lilly said the article addresses "activation syndrome," a topic on which it has published widely and it believes "there is no new scientific information to review."
The theory is that antidepressants can increase the brain chemicals that give depressed people energy, making some patients feel "activated" and symptoms such as anxiety, irritability and hostility can worsen.
In a copy of the article posted on its Web site (www.bmj.com), the British 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.
The FDA in October ordered makers of antidepressants, including Prozac, to put tough warnings on the drugs that they increase the risk of suicidal behavior among children and teens.
"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 ... The safety and efficacy of Prozac is well studied, well documented and well established."
(Additional reporting by Deena Beasley in Los Angeles)