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The British Medical Journal has handed over to the FDA documents that were anonymously delivered to its offices that show that there is a link between the drug fluoxetine (Prozac), made by Eli Lilly, and
suicide attempts and violence. These documents were reportedly missing for more than 10 years include a 1988 document entitled "Activation and Sedation in Fluoxetine Clinical Trials," found that in clinical trials "38% of fluoxetine-treated patients reported new activation but 19% of placebo-treated patients also reported new activation yielding a difference of 19% attributable to fluoxetine."
(Related article: First
Prozac class action lawsuit filed in Canada) It is important to point out that Prozac has been linked to such adverse side effects and there have been calls in the past for recall of Prozac. However, not enough evidence was available though the FDA issued a warning that antidepressants can cause agitation, panic attacks, insomnia, and aggressiveness.
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 Eli Lilly, like Merck in the Vioxx recall case, is not admitting that it has done anything wrong. In a statement released almost immediately, the company says,
"To our knowledge, there has never been any allegation of missing documents from the Wesbecker trial or any other trial involving Lilly. Further, it has always been Lilly's objective to publicly disclose data about both the safety and efficacy of fluoxetine. Lilly has made several requests to the BMJ to obtain copies of the supposed "missing" documents; we still await these documents. 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.
The BMJ article addresses "activation syndrome." It is important to point out that Lilly has published widely in the area of activation syndrome as it relates to fluoxetine. Lilly has consistently provided regulatory agencies worldwide with results from both clinical trials and post marketing surveillance (safety monitoring after drug approval), including those related to fluoxetine. Based on this, Lilly believes that there is no new scientific information to review on this topic. In addition, contrary to what is stated in the BMJ article, it is well established scientifically that fluoxetine does not act in the same manner as
cocaine."
We will be monitoring this development closely to find out if FDA will ask Eli Lilly to
recall Prozac or if
attorneys will file
Prozac related class action lawsuits on behalf of millions of people who have taken Prozac. Prozac has been prescribed for more than 50 million people worldwide.
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