The FDA has warned Pfizer to keep closer tabs on its clinical trials. At issue: a pediatric trial of its antipsychotic drug Geodon. According to the agency, at least 13 children in the trial received overlarge doses of the drug. Pfizer "failed to ensure proper monitoring" of the trial, and the "widespread overdosing" was neither "detected nor corrected in a timely manner," the letter states.
Pfizer is working toward FDA approval to market Geodon as a treatment for bipolar disorder in children, and this trial is part of that effort. An advisory committee has given "cautious support" to the new indication, Reuters reports. When submitting trial results to the FDA, Pfizer excluded data from trial sites with "widespread violations," the company said.
The children who received overdoses did experience side effects such as tremors and restless legs, but they didn't last, and there was no long-term injury, the company said. Just two of the patients did not continue with the study.
Pfizer also said that it has improved its oversight of clinical trials. The company "has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators," Pfizer says in a statement.
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