Drug giant Pfizer has canceled a scheduled clinical trial of its antipsychotic drug Geodon after the FDA accused it of subjecting child participants in a prior study to “widespread overdosing.”
“After careful consideration, the company decided not to proceed with the study,” Pfizer spokesperson Gwendolyn Fisher said.
Fisher said that although the company had taken “preparatory steps” toward the trial, it had decided to abandon the study in order “to meet regulatory timelines.” No patients were enrolled.
Pfizer is seeking FDA approval to market Geodon for the treatment of bipolar disorder in children between the ages of 10 and 17. An FDA panel already rejected this use once in 2009 by a vote of 10-7, expressing concern that large numbers of participants had failed to complete clinical trials of the drug. The FDA asked Pfizer for further information on the drug’s safety in children, and the company responded by launching pediatric trials of the drug.
In April, the FDA warned the company that researchers in charge of the trials were engaging in “significant violations,” including “widespread overdosing” caused by inadequate company oversight.
Five months earlier, Pfizer had agreed to pay $2.3 billion to settle a collection of federal and state criminal and civil charges that it had improperly marketed Geodon and three other drugs.
Geodon, which made Pfizer $1 billion in 2009, is already approved for the treatment of bipolar disorder and schizophrenia in adults. Its competitors AstraZeneca and Eli Lilly have already secured FDA approval to use their respective antipsychotics Seroquel and Zyprexa to treat bipolar disorder in children.
Treatment of children with antipsychotics remains a controversial practice amid growing concern over major side effects such as severe metabolic changes and weight gain.
Although Geodon’s most recent safety trial has been canceled, the company made it clear that it still plans to secure FDA approval for pediatric use of the drug.
Are you drugging your child unknowingly?