Overdosing children in clinical trial

Once again, Pfizer is being censured by the FDA. This time for overdosing children in a clinical test for Geodon.

Here is the story via a NPR report

The Food and Drug Administration just took Pfizer, the world’s largest drugmaker, to task for failing to supervise a clinical test of the antipsychotic drug Geodon closely enough to prevent children from getting excessive doses that led to tremors and other side effects.  

Bottle containing Geodon, an antipsychotic medicine.Pfizer’s Geodon isn’t approved for use in kids. (Pfizer)

In a stern letter to the company’s head of research, the agency concluded that lax monitoring of doctors resulted in “widespread overdosing” of patients in a study of the medicine for the treatment of bipolar disorder in children. The problems were “neither detected nor corrected in a timely manner,” the FDA wrote.

The letter, posted yesterday on the agency’s website, didn’t reveal the name of the drug or the purpose of the study. Pfizer disclosed the test involved Geodon and children with bipolar disorder.

The FDA said Pfizer’s records showed 26 patients received Geodon doses beyond the maximum allowed by the study’s protocol. Some of the side effects from the excessive amounts of medicine included restless legs, tremors and facial tics.

One reason the agency came down so hard on Pfizer is that some of the problems were repeats of issues that surfaced in 2005. It’s also the case that the growing use of antipsychotic medicines in children has been dogged by controversy. Side effects can be serious, and in many cases the medicines have been used in children before being approved by FDA for that purpose…

more via NPR

Here is a link to juicy details on this story from Jim Edwards at BNET PharmaBlog 


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