Geodon is a brand name for the drug ziprasidone. It was developed by the pharmaceutical company Pfizer and approved by the Food and Drug Administartion for use in the treatment of schizophrenia and bipolar disorder in February of 2001.
The drug is manufactured in a both an oral and intramuscular presentation.
Pediatric Risks with Geodon
On April 9, 2010, the Food and Drug Administration issued a warning letter to the manufacturer of Geodon, Pfizer, stating that the drug manufacturer had, "failed to ensure proper monitoring" of a trial being conducted on children.http://www.reuters.com/article/idUSTRE63J5OD20100420 According to the FDA, several children who had received the drug Geodon as part of a trial test to get approval of the drug for use with pediatric patients suffering from bipolar disorder and schizophrenia, suffered from unintended overdoses, tremors, restless leg syndrome and other unnamed complications.http://www.reuters.com/article/idUSTRE63J5OD20100420
The FDA claimed that the instances of overdosing were, "widespread." adding that it "was neither detected nor corrected in a timely manner." http://online.wsj.com/article/BT-CO-20100420-713021.html?mod=WSJ_latestheadlines
The warning letter released by the FDA stemmed from a trial study conducted by Pfizer from 2005 through 2009 and an FDA inspection conducted in 2009. According to both Pfizer and the FDA none of the children affected suffered any long term consequences form the incident and only two were removed from the study.http://www.reuters.com/article/idUSTRE63J5OD20100420
To date, Geodon has not received FDA approval for use in pediatric patients.
Geriatric Risks with Geodon
In 2005, the FDA released an alert concerning certain antipsychotic medication covering the drugs Abilify, Zyprexa, Risperdal, and Geodon, indicating that their none intended use in geriatric patients suffering from dementia resulted in a higher rate of mortality. Most deaths in such circumstances were brought about from sudden heart failure or submission to infectious diseases such as pneumonia.http://www.healthsquare.com/newrx/geo1590.htm
This warning is still present for Geodon and is therefore not recommend for use in elderly patients that experience dementia symptoms, even those brought about by the effects of Alzheimer disease.http://www.healthsquare.com/newrx/geo1590.htm
FDA Warns of Higher Mortality for Elderly Using Geodon
This video highlights the warning issued by the Food and Drug Administration in 2005 after studies indicated that elderly patients suffering from dementia who had been treated with Geodon experienced a higher level of mortality as compared to those that had not. the cause of death was usually due to cardiovascular failure or submission to infectious diseases.
Disclaimer
The content in this page is not a substitute for professional medical advice. Please contact your doctor before taking Geodon.
References
Fast Facts
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Generic Name
Ziprasidone
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Developed By
Pfizer
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FDA Approval
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Treatment For
schizophrenia and bipolar disorder
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Presentations
Oral and intramuscular
