Qui Tam

FDA Warns Pfizer About Pediatric Trials of Geodon

By Nolan and Auerbach

On April 9^th, 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.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

Full post as published by Pharma 101 - Pharmaceutical Fraud on April 26, 2010 (boomark / email).