UPDATE 1-U.S. warns Pfizer on overdosed children in study

Posted on Apr 23, 2010 in Uncategorized

Tue Apr 20, 2010 1:21pm EDTStocks

WASHINGTON, April 20 (Reuters) – U.S. health regulators have warned Pfizer Inc (PFE.N) 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.

The FDA letter follows an agency inspection between May and June 2009. A June 2009 response from Pfizer acknowledged the problems, but did not include a detailed list of the drugmaker’s plans to prevent future problems, the FDA said.

It posted the letter on online at: link.reuters.com/waf68j (Reporting by Susan Heavey. Editing by Robert MacMillan)