Eli Lilly has defended itself in the face of claims from the British Medical Journal that the US Food and Drug Administration is to review classified documents that disappeared during a controversial lawsuit over ten years ago linking its Prozac (fluoxetine) antidepressant with suidical attempts and violence, saying that it was not aware of the documents.
“To our knowledge, there has never been any allegation of missing documents from the… trial or any other trial involving Lilly,’ the firm said in a statement, adding that it had made “several requests” to the BMJ to obtain copies of the supposed “missing” documents, which it is still waiting for. “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,” it added.
The BMJ says that the “missing” documents, which it received late last year, suggest that Lilly executives were aware as early as the late 1980s of possible negative side effects associated with Prozac’s use, but tried to reduce their effect on the drug’s prescribing.
The FDA’s Dr Richard Kapit, who originally approved Prozac, told the BMJ that he had not been given the data in question. “These data are very important. If this report was done by Lilly or for Lilly, it was [the firm’s] responsibility to report it to us and to publish it,” he is quoted as saying. Lilly said that it had widely published results of trials including Prozac in the treatment of activation syndrome – symptoms such as agitation, panic attacks, insomnia, and aggressiveness – and believes that there is no new scientific information to review on this topic.