Federal regulators say the drugmaker Pfizer has failed to correct problems with its testing procedures that resulted in overdoses of several children during a company trial.
The Food and Drug Administration issued a warning letter saying Pfizer did not properly monitor physicians testing an experimental medication, which the agency did not name. A Pfizer spokeswoman said the drug is Geodon, which the company was studying for children with bipolar disorder.
The trial was completed in July 2007 and the FDA is now considering whether to approve the pill for children.
The FDA warning letter, posted online, follows up on problems first cited in 2006, when 26 pediatric patients in a company trial received overdoses of the psychiatric drug. Despite Pfizer retraining the physicians, FDA says three additional overdoses occurred in 2007.
A July 2009 inspection, which prompted the new warning found Pfizer was still not following its own guidelines for safely conducting the study. Specifically, FDA inspectors said that the company was not alerting clinical investigators to new dosing problems as they occur.
Geodon prolongs the heart’s electrical cycle. Short-term studies suggest children are sensitive to these changes in the heart and may be more susceptible to potentially deadly arrhythmias, according to an FDA staff review. Outside advisers to the agency backed pediatric use in June, with most members calling for more testing to evaluate the risks.
While Pfizer responded to the agency’s complaints in July, the FDA letter states that “the response did not contain a detailed outline of procedures or processes that would be implemented to prevent the future occurrence of these observations.”
The FDA letter, dated April 9, demands that Pfizer, which is based in New York, submit a plan for correcting the problems within 15 business days.
Geodon, part of the antipsychotic drug class, is already approved to treat schizophrenia and bipolar disorder in adults. Side effects include diabetes, facial spasms and seizures.
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