The U.S. Food and Drug Administration posted a warning letter earlier this month, directed at the pharmaceutical company Pfizer. It states that at least 13 children overdosed in Pfizer’s clinical trials for the antipsychotic medication Geodon. The FDA said the overdosing was neither “detected nor corrected in a timely manner,” and they called the violations “significant.” The FDA has ordered Pfizer to outline a plan to make certain that future clinical trials do not violate federal regulations.
The FDA reports that the overdosing incidents were discovered during their inspections of clinical trial sites from May 9 to June 3 of last year. The warning letter also noted that Pfizer had received a previous warning in 2005 about inadequate monitoring of dosage in clinical trials, and that although Pfizer had made an effort to retrain clinical study investigators, additional FDA inspections in 2006 and 2007 also revealed dosage problems.
The patients affected by the Geodon overdoses reported side effects including restless legs and “severe” muscle tremors, but did not experience a lasting negative impact on their health.
A Pfizer representative said that the company would comply with the FDA decision.
Geodon, also known as Ziprasidone and sometimes marketed as Zeldox, is a medication used to treat patients suffering from schizophrenia and schizoaffective disorder, as well as bipolar disorder. It has already been approved by the FDA for use with adult patients, but not with pediatric patients. The purpose of the Pfizer trials where the violations were found was to test the effectiveness and safety of the medication in children.
Although Geodon is not yet approved by the FDA for pediatric use, doctors are permitted under U.S. law to prescribe it to children on an “off-label” basis. In 2008, pediatric prescriptions accounted for 11 percent of all use of Geodon, according to the FDA. However, Pfizer cannot legally describe Geodon as a medication for children in its marketing materials or in information distributed to doctors.
In September 2009, Pfizer pleaded guilty to misbranding four medications, including Geodon, “with the intent to defraud or mislead.” The company was fined $2.3 billion, and additionally paid $33 million to settle allegations of promoting Geodon for pediatric use when it did not have FDA approval.
If Pfizer completes pediatric trials of Geodon and the results are approved by the FDA, they will gain the legal right not only to call Geodon a medication for children, but also to exclusively market it as such in the United States for six months. After those six months have expired, other pharmaceutical companies will gain the right to market generic versions of the same drug for the same purpose. The FDA has not yet announced whether the clinical trial violations will affect their decision on granting Pfizer exclusivity for pediatric Geodon.
If you or a loved one are a prescribed user of Geodon and have experienced serious side effects or have overdosed, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with the side effects of prescription medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.