Warning Added to ADHD Drug

FEBRUARY 01, 2005

Eli Lilly and Co is taking swift action to notify pharmacists, physicians, and patients regarding the warning added to its drug Strattera. The drug is indicated for the treatment of attention deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults. The warning indicates that the medication should be stopped in patients with jaundice or laboratory evidence of liver injury. The revised label discusses 2 reported cases of severe liver injury out of >2 million patients who have taken the medication since its approval. The patients who experienced the liver problems have had normal liver function since discontinuing the medication.

Lilly has been notifying physicians, other health care providers, and consumer advocacy and professionally focused associations regarding the label change so that they have the tools to provide important information to patients. Lilly's outreach efforts include a "Dear Healthcare Professional" letter, sales force communication to prescribers, and information on Strattera's Web site (www.strattera.com). "Patient safety is our top priority at Lilly," said Douglas Kelsey, MD, a pediatrician and a clinical research physician at Eli Lilly and Co, in a press statement.