Geodon Tests on Children Canceled After FDA Warning

Pfizer announced last week that it is canceling plans for more clinical trials involving its antipsychotic drug Geodon with children. The announcement follows an FDA warning issued earlier this year that found the drug maker had repeatedly overdosed children on Geodon due to lax protocols in a previous clinical trial. 

Pfizer has been looking for FDA approval of a new indication to use Geodon as a treatment for pediatric bipolar disorder. However, the FDA rejected the application last fall, requesting new information on the effect of Geodon on bipolar children. However, Pfizer has balked at doing new Geodon trials for bipolar children after coming under heavy fire for another clinical trial involving children taking Geodon.

In April, the FDA blasted Pfizer in a warning letter for failing to correct or detect Geodon overdoses being given to children in a timely manner. As a result, at least 13 children received Geodon overdoses, with adults and children alike receiving significant drug overdoses daily on consecutive days. The FDA letter said some were subjected to overdoses of the drugs for 16 consecutive days. One subject received 30 days of total overdosing and experienced sleep problems, facial tics and chemical imbalances.

Pfizer responded to the FDA warning letter by promising to provide an outline of processes aimed at preventing similar problems from occurring during its clinical trials in the future.

Pfizer would have to launch a new clinical trial specifically dealing with children with bipolar disorder, and the data would likely come too late to help the company meet a deadline for pediatric exclusivity. Exclusivity for Geodon will expire in November 2012, which would not be enough time for Pfizer to finish clinical trials before generic Geodon would become available.

Geodon (ziprasidone) is an atypical antipsychotic that was approved by FDA in 2001 for the treatment of bipolar disorder and schizophrenia in adults.

FDA staff members have expressed concerns about the side effects of Geodon, Seroquel and other antipsychotics when taken by children, indicating that further research is needed about the possible risk of weight gain and diabetes.

Last year, Pfizer plead guilty to charges that it illegally promoted Geodon and several other drugs for off-label uses not approved by FDA. Pfizer paid $2.3 billion to the U.S. Department of Justice in a settlement that included a corporate integrity agreement.