FDA Mulling Antipsychotics for Kids

The Food and Drug Administration is now considering whether to approve the use of Zyprexa, Seroquel, and other powerful antipsychotic drugs in children as young as 10 years old.

The drugs already are approved to treat bipolar mania and schizophrenia in adults and account for billions of dollars in annual sales for the drug makers. Pfizer Inc., Eli Lilly & Co., and other drug companies now want permission to begin marketing the drugs for kids. Many doctors already prescribe the drugs to kids, but the FDA has not approved them for those uses and companies cannot promote them for use in children.

An FDA advisory panel of medical experts is set next week to meet and consider the risks and benefits of approving the drugs for kids. The panel will make a recommendation to the FDA, which will then issue a ruling. While the FDA is not obligated to follow the advice of the panel, it most often does.

Already, some in the FDA are expressing serious concerns about exposing children to antipsychotic drugs at such a young age and how prolonged, lifetime use of the drugs may affect the health of children who become adults.

Drug Companies Seeking Expanded Approvals

Pfizer wants its drug, Geodon, approved for treating children with pediatric bipolar disorder. Lilly is seeking approval for its drug, Zyprexa, which has been linked to diabetes and weight gain in adults, to be used to treat children with schizophrenia and manic depressive disorder. AstraZeneca also wants its Seroquel approved for schizophrenia and manic depressive disorder. Seroquel has been blamed for causing blood sugar disorders in adults.

Zyprexa has been shown to cause a greater risk and degree of weight gain in children when compared to adults, the FDA said. Studies of the drug for treatment of schizophrenia found that 30 percent of adolescents taking the drug gained weight while just six percent of adults did. Also, adolescent patients gained more weight on average than adults, 10 pounds compared to six pounds.

Studies of Geodon found that children taking the drug were more likely to cause sleepiness and dystonia, a condition which causes muscle spasms. Seroquel also produced more appetite and increased blood pressure in adolescents and children compared to adults.

Millions of Americans Affected

As many as 2.4 million Americans have been diagnosed with schizophrenia, a disorder which cause hallucinations, delusional thoughts, and impaired social interaction. Bipolar disorder, which results in rapid and sudden mood swings and changes in energy, affects another 5.7 million people in the United States, according to the National Institute of Mental Health.

Despite the findings of adverse effects in children, the fact that schizophrenia and biopolar disorders are increasingly diagnosed in adolescents and children may prompt the FDA to approve the drugs. Still, with so much evidence of severe problems associated with the drugs, drug-safety officials should be sure not to rush to judgment on approving antipsychotics for children to avoid a lifetime of dependence on harmful and dangerous drugs.

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