Antipsychotic Use Among Young Children Up Despite Risks and Questions

The number of preschoolers being prescribed potentially dangerous antipsychotic medications has doubled in recent years, even though half of children receiving the drugs have not had any other mental health care, researchers say. The increased use comes amid concerns about long term side effects of antipsychotics and questions about the effectiveness among children as young as two years old.

A new study by Columbia University and Rutgers University found that the number of children between 2 and 5 years-old being prescribed antipsychotics has steadily increased, despite the drugs not being approved for use in children that age. There is also a lack of knowledge about the short-term or long-term effects and researchers found that a disturbing number of children are being given the antipsychotics without even the most basic mental health care recommended before receiving such powerful medications.

The findings come at a time when FDA staff members are calling for a more in-depth investigation on the metabolic side effects among children of antipsychotics like Seroquel, Zyprexa and other newer medications. Despite the recent FDA approval of Seroquel in the use of children ages 13 to 17, reviewers from FDA’s pharmacovigilance division are warning that there needs to be more study on Zyprexa and Seroquel side effects on children.

The most recent study will be published in this month’s issue of the Journal of the American Academy of Child and Adolescent Psychiatry. Researchers from Rutgers and Columbia looked at private health insurance data on about one million children, and found that the rate of children ages 2 to 5 who are being prescribed antipsychotics has doubled from 1999-2001 to 2007, from one in every 1,300 children, to one in every 630 children.

Johnson & Johnson’s Risperdal (risperidone) was the most commonly prescribed antipsychotic among very young children, and was given most often to males ages 4 and 5 to treat developmental disorders, retardation, attention deficit/hyperactivity disorder or disruptive behavior disorder.

The use of antipsychotics in children should only be a method of last resort in children with the most severe mental disorders, researchers said. But data in the study revealed that less than half of the children on antipsychotics had received any mental health services.

The study comes on the heels of a recent report published in an October issue of the Journal of the American Medical Association which found that atypical antipsychotics caused dramatic weight gain in children, reinforcing some fears that the drugs may be linked to the onset of childhood diabetes.

That study found that after only 11 weeks, children on Zyprexa gained an average of 18.7 pounds, while Seroquel side effects caused an average weight gain of 13.5 pounds, and Risperdal caused 11.7 pounds of weight gain on average.

AstraZeneca currently faces thousands of Seroquel lawsuits that allege the company failed to adequately warn about the risk of weight gain and other metabolic side effects, which allegedly caused users to develop diabetes and other Seroquel health problems. All federal Seroquel cases have been consolidated in an MDL, or multidistrict litigation, that is centralized in the U.S. District Court for the Middle District of Florida.

Atypical antipsychotics generate more than $12 billion in sales every year, with Seroquel (quetiapine fumarate) leading the pack with nearly $4.45 billion in sales last year.