FDA Warns Pfizer About Pediatric Trials of Geodon

On April 9th, the FDA issued a Warning Letter to Pfizer, Inc. concerning its conduct during a clinical trial for one of its prescription drugs on the market. According to a Wall Street journal article (“FDA Warns Pfizer About Pediatric Trials of Geodon,” April 21, 2010) the drug (name redacted in the Warning Letter) is Geodon, which is FDA-approved to treat schizophrenia and bipolar disorder in adults. The FDA admonished Pfizer over its failure to properly monitor the clinical trials resulting in excessive doses given to pediatric subjects. The Warning Letter reads “dosing errors occurred and overdosing extended over several days for all seven pediatric subjects; in one case for as long as 22 days.” Geodon does not have a pediatric indication.

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