FDA warns Pfizer over Geodon trials

The US Food and Drug Administration (FDA) posted a warning letter on its website on April 20 claiming "significant violations" were discovered during an inspection of a Pfizer clinical trial site between May 4 and June 3, 2009. 

The letter, dated April 9, did not mention the name of the medicine and the study, but Pfizer spokeswoman, Kristen Neese, has confirmed it related to the use of Geodon in children with bipolar disorder. Geodon is approved for the treatment of schizophrenia and bipolar disorder in adults, but the company is seeking further approval to use the product in paediatric patients ages 10 to 17. 

In 2006, 26 patients in a company trial of the psychiatric drug received overdoses and, despite Pfizer retraining the physicians, three additional overdoses were documented in 2007.

The July 2009 inspection, which prompted this new warning, however found that Pfizer was still not following its own guidelines for conducting the study safely and was not alerting clinical investigators to new dosing problems as they occur.

The letter demands that, within 15 days, Pfizer notify the FDA in writing of the actions it has taken (including corrective action plans and standard operating procedures) to prevent similar violations in the future. It warns that failure to explain the violations noted above adequately and promptly may result in regulatory action.

According to Neese: "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."