Schizophrenia Drug Has Warnings Added to Label

INDIANAPOLIS, Oct. 8 -- Olanzapine (Zyprexa) labeling will be altered to include stronger warnings about weight gain, hyperlipidemia, and hyperglycemia, according to a statement from Lilly.

The drug maker said the new warnings would also be added to a combination of olanzapine and fluoxetine marketed as Symbyax. In its statement, the company said it agreed to the label changes as part of on-going discussions with the FDA. Lilly is seeking FDA approval to market olanzapine for treatment of adolescents.

Lilly said it would inform physicians of the beef-up warnings in a "Dear Healthcare Practitioner" letter. It said it would also notify professional and consumer groups of the changes.

The company said the updates reflect "recently completed pooled analyses of Lilly's clinical trial data in adults and adolescents, information from two large non-Lilly studies of atypical antipsychotics (CATIE and CAFE) and discussions with the FDA"

The new warning will also state that there is a greater association increases in glucose with olanzapine than with some other atypical antipsychotics.

"Today's communication is part of Lilly's historical and ongoing commitment to inform doctors and patients about updated prescribing information," said Sara Corya, M.D., the global medical director of Lilly. "Zyprexa is an important treatment option for patients suffering from the devastating effects of schizophrenia and bipolar disorder, as is Symbyax for patients with bipolar depression. This information will continue to help healthcare professionals evaluate and make the best treatment decisions for individual patients."

The company said the labels of both products already include information about "potential risks of weight gain and elevations in blood sugar," but the new language will strengthen those warnings.

Dr. Corva said physicians should consult guidelines for treating people with antipsychotics, "particularly the monitoring of lipids and blood glucose, regardless of the medication prescribed."

According to a report in the New York Times Lilly has spent .2 billion since 2004 to settle lawsuits from 28,500 people who claimed they developed diabetes or heart problems after taking the drug. At least 1,200 more lawsuits are still pending.

In 2004, the American Diabetes Association said that olanzapine was more likely to cause diabetes than other commonly prescribed antipsychotic medicines, although the FDA has never made a distinction between olanzapine and other drugs.