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 Tuesday, 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.
Pfizer said in a statement only 10 of those overdoses were caused by physicians, and the rest were likely due to patient error. None of the overdoses were fatal, but several patients reported tremors and restless leg syndrome, according to the FDA letter.
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.
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.
Pfizer spokeswoman Kristen Neese said many of the problems cited by the FDA were first pointed out by the company itself more than four years ago.
“Pfizer has communicated with the FDA about our conduct of clinical trials and, over the next two weeks, will provide an outline of new and existing processes for preventing similar issues with Pfizer clinical trials,” Neese said in a statement.
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.
The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing, marketing and testing. The letters are not legally binding, but the agency can take companies to court if they are ignored.
Pfizer shares fell 3 cents to close Tuesday at $16.76.
- Associated Press