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Pfizer has been criticised by the Food and Drug Administration (FDA) for allegedly failing to correct flawed testing procedures that caused several children to overdose in a drug trial.
While the FDA did not name the treatment in a warning letter issued to the firm, a Pfizer spokesman said the case referred to a trial of Geodon, an experimental medication for children with bipolar disorder.
The regulator claimed 26 paediatric patients had been given overdoses of the drug during trials that ran in 2006. It blamed the incidents on a failure by Pfizer to properly monitor its physicians. Despite the company retraining the members of staff in question, three more overdoses occurred in 2007.
A later inspection by the FDA in 2009 found that the firm was still not following safety guidelines, claiming clinical investigators had not been alerted to new dosing errors as they occurred.
Responding, Pfizer said that only 10 of the overdoses, none of which were fatal, had been caused by physicians, with the rest down to patient error.
The regulator has yet to make a decision on whether to approve the drug, already used to treat adults with schizophrenia and bipolar disorder, for children.
Copyright Press Association 2010
Pfizer
