Children Received Geodon Overdose During Pfizer Drug Trials, FDA Says

The drug maker Pfizer gave at least 13 children overdoses of its antipsychotic drug Geodon during clinical trials, according to federal investigators. 

The FDA issued a warning letter to Pfizer earlier this month, accusing the company of failing to properly monitor a clinical trial that resulted in “widespread overdosing” of children with the powerful antipsychotic drug. The children suffered tremors and restless legs, but have not suffered any apparent long-term injuries as a result of the overdoses, investigators say.

Late last week, Pfizer responded to the charges, with a statement on its clinical trial procedures. The company has promised to provide an outline of processes aimed at preventing similar problems from occurring during its clinical trials in the future.

The agency blasted the company in its warning letter for failing to correct or detect Geodon overdoses being given to children in a timely manner. According to the letter, adults and children alike received significant drug overdoses daily on consecutive days, with some being 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.

“The final Clinical Study Report submitted to the FDA lists 40 total subjects reported to have had a protocol deviation related to dosing error, including 20 subjects who exceeded the maximum protocol dose,” the warning letter states. Nine site visits by a Pfizer data management team failed to detect the overdoses, the FDA found.

Geodon (ziprasidone) was approved by FDA in 2001 for the treatment of bipolar disorder and schizophrenia in adults. It is an atypical antipsychotic. The clinical trials, which took place in 2006 and 2007, were part of an ongoing effort by Pfizer to gain approval to market Geodon for use by children.

FDA staff members have said that the side effects of Seroquel, Geodon and other antipsychotics need to be further studied due to the possible weight gain and diabetes effects on children.

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.