By Scott Hensley
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.
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.
The agency hasn't approved Geodon for use in children. In 2008, kids between the ages of 7 and 17 accounted for 11 percent of Geodon use, Bloomberg reports, citing data posted online by the FDA. Doctors can prescribe a medicine already on the market for unapproved uses, but companies aren't allowed to promote uses the FDA hasn't blessed.
Last year, Pfizer agreed to settle federal charges it illegally promoted Geodon for unapproved uses, including treatment of children, and paid the government more than $300 million.
In a statement, Pfizer said, "patient safety is a top priority." The company "recognizes the seriousness of the issues cited by the FDA and is committed to fully addressing FDA's concerns."
For its part, the company said many of the problems flagged by the agency "were first uncovered and reported to the FDA by Pfizer as far back as four years ago as part of our ongoing clinical trial monitoring and quality assurance processes."
Pfizer said it has beefed up monitoring of clinical trials, including closer oversight of doctors working on the projects. The company said it would respond to the FDA's letter in the next two weeks.