FDA Staff Urges More Review of Seroquel and Zyprexa Use in Kids

The use of powerful antipsychotic drugs like Seroquel and Zyprexa in children should be further studied to determine the risks of metabolic disorders and other serious health complications, Food and Drug Administration staffers say in a new report.

FDA drug reviewers said medical researchers have found a direct link between the use of so-called atypical antipsychotics in younger children and weight gain, high cholesterol, and increased blood pressure, according to a Reuters news report.

Seroquel, Zyprexa and similar antipsychotic drugs are not approved for use in children, but an estimated two million American children are given the drugs by doctors each year to treat a variety of psychiatric disorders. An FDA advisory panel recently recommended approving their use in kids.

The research findings should prompt further FDA evaluation to determine the extent of the risks and possibly take action to limit the use of Zyprexa, Seroquel, and similar drugs in younger age groups, staff in the FDA’s division of pharmacovigilance wrote in an October 14 memo, according to Reuters.

FDA analysis of current medical studies on the use of Eli Lilly’s Zyprexa and the AstraZeneca drug Seroquel found increased risks of metabolic disorders in children given the antipsychotics, officials said.

In October, a study found Children taking commonly prescribed psychiatric drugs like Abilify, Risperdal, Seroquel, and Zyprexa were more likely to quickly gain weight and become obese in a matter of months after starting the drugs.

Seroquel also has been linked increased risks of diabetes and other blood sugar disorders as well as other serious side effects. Earlier this year, AstraZeneca agreed to pay $520 million to settle accusations the company illegally marketed Seroquel for uses that were not approved by the FDA.

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