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December 31, 2004

Potential Deadly Side-effects of Prozac: Medical journal turns missing murder case documents over to FDA

Topics: Clinical Pharmacology

I found this at Science Blog today and it is troubling news about an apparent Eli Lily cover-up of a possible link between fluoxetine(Prozac), and violence and suicide attempts in patients taking the drug. However, in JAMA. 2004 Jul 21;292(3):338-43, "Antidepressants and the risk of suicidal behaviors" the authors concluded that after starting antidepressant treatment with fluoxetine the risk is similar that of amitriptyline and paroxetine. (see PUBMED article abstract below)

First we have:
The British Medical Journal has turned over confidential drug company documents
that went missing from a 10 year old murder case to the US Food and Drug Administration (FDA) for review. The documents, which were sent to the BMJ by an anonymous source, appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence. They also suggest that Eli Lilly officials were aware in the 1980s that fluoxetine had troubling side effects and sought to minimise their likely negative effect on prescribing.

The documents reportedly went missing during the case of Joseph Wesbecker in 1994, who killed eight people at his workplace in 1989, while taking fluoxetine. He then shot and killed himself.

In 1994, some of the relatives of the victims brought a civil suit against Eli Lilly, alleging that the company had known about the side effects of fluoxetine for years (including the fact that it might increase violence). The company won the case, but was later forced to admit that it had made a secret settlement with the plaintiffs during the trial, which meant that the verdict was invalid.

One of the documents, dated November 1988, reports that in clinical trials fluoxetine can cause behavioural disturbances. The FDA recently issued a warning that antidepressants can cause stimulatory side effects such as agitation, panic attacks, insomnia, and aggressiveness.

These documents provide "the missing link" between the recent FDA advice and what Lilly scientists knew 16 years ago, says Harvard psychiatrist Dr Joseph Glenmullen.

Dr Richard Kalpit, the FDA clinical reviewer who approved fluoxetine, said he was not given the Lilly data. "These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it."

Congressman Maurice Hinchey (Democrat, New York), who is currently reviewing the documents to determine whether Lilly withheld data from the public and the FDA, said: "This case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA approved drugs so that patients and their doctors, not the drug companies, decide whether the benefits of taking a certain medicine outweigh the risks."

Lilly has defended their drug saying, "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 efficiency of Prozac is well studied, well documented, and well established."          From British Medical Journal  via Science Blog...

However, in JAMA. 2004 Jul 21;292(3):338-43, "Antidepressants and the risk of suicidal behaviors" the authors concluded that after starting antidepressant treatment with fluoxetine the risk is similar that of amitriptyline and paroxetine.

The risk of suicidal behavior after starting antidepressant treatment is similar among users of amitriptyline, fluoxetine, and paroxetine compared with the risk among users of dothiepin. The risk of suicidal behavior is increased in the first month after starting antidepressants, especially during the first 1 to 9 days. A possible small increase in risk (bordering statistical significance) among those starting the newest antidepressant, paroxetine, is of a magnitude that could readily be due to uncontrolled confounding by severity of depression. Based on limited information, we also conclude that there is no substantial difference in effect of the 4 drugs on people aged 10 to 19 years.     PMID: 15265848 [PubMed - indexed for MEDLINE

But the above study is not definitive, there are apparently other studies and data that has been turned over to the BMJ that indicate other than as summarized in the JAMA study above. We will have to just wait and see what the FDA comes up with. In the meanwhile, physicians should use caution in prescribing Prozac until much more is known about this case and the records that have just now become availble.

Posted by Hyscience at December 31, 2004 4:01 PM

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