US FDA finds 'significant violations' in Pfizer's pediatric trials of Geodon

Global drugs behemoth Pfizer has been notified via a warning letter from the US Food and Drug Administration of "significant violations" involving pediatric trials of an antipsychotic drug found during inspections of several clinical investigators involved in the studies. Although the drug was not named in the letter, according to a Wall Street Journal report, a company spokeswoman identified as being its Geodon (ziprasidone), currently approved to treat schizophrenia and bipolar disorder in adults.

The warning concerns excessive dosing of an antipsychotic drug during a clinical trial, and it appears to have resulted, at least in part, by lack of communication to trial monitors of errors discovered by a Pfizer data management team.

Some 13 children and at least 20 adults received too much of the drug. The FDA inspection of the trial is part of the Bioresearch Monitoring Program, intended to protect human subjects.