Posted by Sunnely on May 31, 2001, at 20:23:35
In reply to Now that you've said that, Sunnelly, posted by grapebubblegum on May 31, 2001, at 8:26:20
The "Patient Summary of Information About Geodon" furnished by Pfizer indicates that "Geodon has not been shown to be safe or effective in the treatment of children and teenagers under the age of 18 years old." Having said that, that doesn't mean that doctors can't prescribe Geodon for children under age 18. This information was furnished by Pfizer to comply with the FDA's requirement. The FDA does not regulate doctors prescribing practice. However, doctors are expected to know the action, interactions, side effects, necessary precautions to take, etc. when prescribing a drug. Your son's doctor is not required to do an ECG prior to prescribing Geodon. The decision to do or not an ECG is left to the clinical judgment of each individual physician. Another doctor would probably order it.
The Prolong QTc Story with Ziprasidone (Geodon):
When the FDA first reviewed the ziprasidone application, they seemed reasonably satisfied with the safety profile of ziprasidone based on the clinical trials experience. For example, the FDA initially did not request an advisory board meeting, which would be expected when there are signficant safety concerns. The FDA ultimately rejected the first ziprasidone application, but the decision was not based on any known safety problems. Rather, the FDA decided that there was not enough information about the QTc prolongation associated with ziprasidone under unknown circumstances, such as a patient taking ziprasidone along with another medication that would have the potential for a dangerous drug-drug interaction. Having learned from the lesson of terfenadine (Seldane), astemizole (Hismanal), and cisapride (Propulsid), the FDA needed a more sophisticated way to understand the safety of ziprasidone under circumstances of potential risk. This was the background against which Pfizer went back and conducted one of the most sophisticated cardiac safety studies ever done to date.
Working with the FDA, Pfizer designed a study to assess the cardiac safety of ziprasidone and other antipsychotics when given at high doses and when given with a known metabolic inhibitor. This study randomized hospitalized patients with schizophrenia to receive high doses of haloperidol (Haldol), risperidone (Risperdal), olanzapine (Zyprexa), quetiapine (Seroquel), thioridazine (Mellaril), and ziprasidone (Geodon). A specific metabolic inhibitor for each of these medications was then added. This step replicated in a controlled way the real-world "worst-case" situation in which patients might inadvertently receive a medication that might drive up the blood level and lead to increased risk of torsades de pointes (serious, potentially fatal cardiac arrhythmia).
All six antipsychotics evaluated in the study caused some degree of QTc prolongation. Haloperidol was associated with the smallest change and thioridazine the greatest. In fact, the QTc prolongation associated with thioridazine was much longer than that seen with any of the other medications. The next tier of the increased QTc intervals was associated with ziprasidone, risperidone and quetiapine, which were statistically equivalent. It is important to note that none of the QTc intervals for any of the antipsychotics changed significantly when a specific metabolic inhibitor was added.
Based on this study, there is no evidence that ziprasidone has any greater risk for causing cardiac problems than any of the other atypical antipsychotics. Pfizer resubmitted the ziprasidone application to the FDA. An FDA advisory board met in July 2000 and recommended approval. The FDA approved ziprasidone in February 2001, and it has been available for patients since early March 2001.
What are the Clinical Implications:
Contraindications (Not to be given): Ziprasidone should not be used in combination with other drugs that cause significant prolongation of the QTc interval. For antipsychotic medications, this means patients should not be started on ziprasidone when they are taking thioridazine (Mellaril), mesoridazine (Serentil), or pimozide (Orap). Keep in mind, however, that patients taking any one of these antipsychotics have a greater risk of QTc prolongation than they would on ziprasidone alone. Ziprasidone is also contraindicated for patients with a known history of QTc prolongation, recent heart attack, or symptomatic heart failure.
ECG Monitoring Issues: What about getting baseline or follow-up ECGs? Here, the package insert seems to be fairly clear that baseline or follow-up ECG monitoring is NOT needed. However, that is not to say that getting a baseline ECG isn't a good idea. Common sense will dictate that, if either the doctor or the patient (or family) are worried about this issue, a baseline ECG will go a long way to reassure each one that the situation is safe.
On the positive note, Geodon's selling points (compared to the other atypical antipsychotics) are: 1. "weight neutral" 2. does not induce sugar diabetes or elevates triglycerides. No doubt the antipsychotic drug of choice for those who are overweight or concern about gaining weight, and those concern about developing sugar diabetes and/or elevated cholesterol/triglycerides.
********************************************> I'm not too thrilled that my 5 year old son (74 lbs.) is taking Geodon 20 mg every evening and topamax 75 mg. per day. His pdoc never told me about these possible arrhythmias. I myself have had significant arrhythmias which my cardiologist poo-poohed (I was having "extra beats" which is really a ventricular spasm or a mangled ineffective beat despite the name, correct? every 10 seconds for a while there and the doc just told me to drink more water, eat more salt, and cut down the caffeine, and sure enough the problem subsided especially when I stopped taking zoloft which appeared at one point to worsen the problem).
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> My son's pdoc only sees him 15 minutes per month and never asked or noticed that my son gained about 10 lbs in two months while taking zyprexa but when I pointed out my concern, he was switched to geodon instead, and I have been told of no possible dangers or side effects. Also, I can't be sure this medication regimen is helping for his tentative "bipolar disorder" diagnosis.
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> I look forward to moving out of Florida in one month and finding a good medical practice for my son in Baltimore, Maryland... but in the meantime, if you hadn't told me about this possible geodon effect, I wouldn't have known.
poster:Sunnely
thread:64767
URL: http://www.dr-bob.org/babble/20010530/msgs/64956.html