Overdosing in Clinical Trials Prompts FDA Warning

Pfizer has received an FDA warning letter for significant violations concerning its clinical trials of Geodon. Pfizer is trying to expand Geodon’s use to pediatric patients suffering from bipolar disorder. As of yet, the FDA has not approved Geodon for use in children. The FDA warning letter cited “widespread overdosing” in patients involved in the clinical trials. The letter also noted that the problem was not detected or corrected in a timely fashion. The warning letter came as a result of inspections of Pfizer’s clinical trial sites in 2005 and 2006.
While Pfizer officials vowed to correct the problem, the FDA warning letter stated that the violations were repeat violations involving 7 pediatric patients. In spite of the warning letter, Pfizer will continue to pursue FDA approval for Geodon use for children. This is not the first problem with Geodon. Last fall, Pfizer agreed to pay $2.3 billion to settle federal and state civil and criminal charges stemming from charges of improper marketing of four drugs, including Geodon. In addition, to the settlement, Pfizer agreed to pay several states $33 million to settle claims that the company illegally promoted Geodon for use in children and in higher than approved doses.