On October 5, 2007, Eli Lilly and the United States Food and Drug Administration (FDA) announced an update to the U.S. labels of Zyprexa and Symbyax to include new warnings of hyperlipidemia and an update to existing warnings pertaining to hyperglycemia. New updates reflect analyses of one of Lilly’s clinical trials, two large non-Lilly studies, and discussions with the FDA.

Approximately 22 million people world wide use Zyprexa for the treatment of schizophrenia and maintenance treatment of bipolar disorder.

Symbyax is used for the treatment of bipolar depression.

Updates to Zyprexa and Symbyax labels include new warnings of hyperlipidemia, an elevation of triglycerides and cholesterol which can lead to an increase in risk of cardiovascular disease due to high cholesterol. Also included was updated information in the warning of hyperglycemia, or high blood sugar. Hyperglycemia can pose a serious health problem for those who are diabetic.

Lilly is in the process of communicating the new warning labels to U.S. physicians through a “Dear Healthcare Practitioner” letter. Lilly will contact consumer advocacy and professional associations to provide important information to patients.

Concerned patients and caregivers may contact LillyAnswers Center at 1-800-545-5313 or visit www.zyprexa.com or www.symbyax.com for additional information.

Sources: “Lilly Announces Updates to the Zyprexa and Symbyax U.S. Labels,” PharmaLive, (retrieved October 8, 2007; “Hyperlipidemia,”[American Heart Association, retrieved October 8, 2007; “Hyperglycemia and Diabetes,” WebMD, July 1, 2007.