The Federal Drug Administration on Friday issued a warning to doctors that adolescents taking the drug olanzapine have an "increased potential" -- in comparison with adults taking the new-generation antipsychotic drug -- for weight gain and metabolic disturbances that could result in diabetes or elevated blood cholesterol levels.
"Clinicians should consider the potential long-term risks when prescribing to adolescents," the FDA said in a statement released Friday night. "In many cases, this may lead to prescribe other drugs first," the statement went on.
The agency has not approved the marketing of olanzapine -- sold under the commercial name Zyprexa by the drug maker Eli Lilly -- for use in children under 13 who are diagnosed with schizophrenia or bipolar disorder. But the medication, one of a class of psychiatric medications called the "atypical antipsychotics," is widely prescribed for young patients, despite growing evidence that call its safety profile into question for this population.
The warning comes in the wake of the October publication in the Journal of the American Medical Assn., in which a study showed that children and adolescents taking their first-ever course of Zyprexa gained, on average, more than 17 pounds over a 12-week period, as well as dramatic increases in triglycerides and cholesterol levels -- all factors that put them at higher risk of developing cardiovascular disease. While two other antipsychotic drugs -- Seroquel and Risperdal -- were implicated in significant weight gain and metabolic changes, Zyprexa was found to carry the highest risks of all three.
The FDA said that in cases where physicians opt to prescribe olanzapine, the drug should be part of a "comprehensive treatment program," which could include psychological, educational and social counseling as well as medication therapy.