FDA Claims Pfizer Schizophrenia Drug Ad Misleading

  • The FDA has ruled that Pfizer violated the Federal Food, Drug and Cosmetic Act with a false or misleading advertisement in a medical journal, which claims Geodon (ziprasidone mesylate) for Injection has "proven advantages over haloperidol IM-twice the improvement as measured on the BPRS." (Brook S, et al, J Clin Psychiatry 2000;61:933-941.) This claim, according to the FDA, "has not been demonstrated by substantial evidence or substantial clinical experience."


    The ad fails to list side effects such as neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia and diabetes. Other potentially fatal risks include increased mortality in elderly patients with dementia-related psychosis. Additionally, contraindications and warnings exist about the use of Geodon for Injection in patients with a known history of QT prolongation or in patients on concomitant therapy with other medications that can prolong the QT interval, to name just two of numerous precautions.

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    Swiss cheese holes came to mind when I researched this claim. First, if the FDA is referring to an article published in 2000, why is it first acting seven years later? And what good is an FDA letter to Pfizer if no penalties and fees are imposed as compensatory damage?


    Also, drug companies fund a lot of psychiatrists' studies, and if I recall correctly, there was a movement in peer-reviewed medical journals for study authors to disclose their ties to the pharmaceuticals. This hand-in-pocket palm greasing is more widespread than you might imagine. I truly believe, too, that if you want to create an outcome in your favor, there are ways to set up a study to get the results you seek.


    I'm conflicted because I take Geodon; however, I do think Pfizer should've been honest about the side effects. For me it's lifted me out of paranoia, and I've gained relatively little or no weight, so I'm angry to hear about other possible side effects, like diabetes. I don't take the injectable form, though, so hopefully there's less of a risk.


    My intuition tells me that the FDA letter could make psychiatrists or patients think twice about prescribing or taking this new drug. The Geodon has been a miracle for me. Yet maybe it could indeed sabotage my health down the road. I'm willing to take that chance if it truly gives me peace of mind.


    Not all drugs work equally well for every person who takes them, so I urge you to talk to your psychiatrist about the positives and negatives of any drug regimen you're considering.


    I'll wrap up here by saying that we'll know the truth about the Geodon when Pfizer gets hit with a lawsuit. To mislead the public-and vulnerable patients-is a crime. Let's see the FDA fine drug companies for such acts before they wind up in the courtroom.


    For 20 years I was on Stelazine, an old-school medication that slowly stopped working. I've come to be on the G. because it was the first drug my psychiatrist chose to switch me to. It sounds like I'm biased, and maybe I am, because things are working.


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    For now. As to what the future holds, I take it day-by-day and pill-by-pill. The truth is hard to swallow.


Published On: August 16, 2007