Reuters
April 20, 2010

U.S. health regulators have warned Pfizer Inc. over a series of failures that led to the overdosing of at least 13 children in a clinical trial of its antipsychotic drug Geodon, according to a letter made public on Tuesday.

The FDA, in an April 9 warning letter to the world’s largest drugmaker, said Pfizer “failed to ensure proper monitoring of the investigation” for a product.

The agency did not name the drug in the public version of the letter, but Pfizer confirmed it related to the use of Geodon in children with bipolar disorder.

It said the company did not properly monitor the study and, “as a result of inadequate monitoring, widespread overdosing of study subjects at multiple study sites was neither detected nor corrected in a timely manner.”

Several children given overdoses experienced tremors, restless legs and other complications, the letter said.

Pfizer recognizes the issue’s seriousness and is committed to addressing the concerns, it said. Pfizer reported many items cited in the letter as many as four years ago, it said.

Since then it “has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators,” it said.

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