Why did the FDA require a change to the Zyprexa® label?
In September 2003, the U.S. Food and Drug Administration (FDA) ordered Eli Lilly to revise the Zyprexa® labeling and product information to inform doctors and patients that the use of Zyprexa® (and other SGAs) has been associated with an increased risk of glucose abnormalities and diabetes. On March 1, 2004, Eli Lilly issued a “Dear Doctor” letter to individual physicians in which it informed doctors of the increased risk of hyperglycemia and diabetes in patients taking Zyprexa® and described the label changes.
