Eli Lilly and Company has added a safety warning to the labels of its drug Strattera warning people with jaundice or laboratory evidence of liver injury (hepatotoxicity) not to take the drug. Lilly is notifying doctors of the labeling change after two people taking the medication, indicated for attention-deficit disorder, suffered severe liver damage. Severe liver damage may progress to liver failure, resulting in death or the need for liver transplantation.

Strattera is primarily prescribed for adults as well as patients younger than 18 who have been diagnosed with attention-deficit/hyperactivity disorder, or ADHD. Strattera competes with the Johnson & Johnson drug Concerta and Novartis AG’s Ritalin. Symptoms of ADHD include lack of attention and concentration, or impulsive behavior. Over 2 million people have used Strattera since the FDA approved it for ADHD in November of 2002.

Initial signs of liver damage, or hepatotoxicity, include:

• Itchy skin, called pruritus
• Jaundice
• Dark urine
• Tenderness on the upper-right side of the abdomen
• Flu-like symptoms

Source: Associated Press, “Strattera warning limited,” December 21, 2004; “Lilly announces Important Liver Safety Update to Strattera Label,” Medical News Today, December 19, 2004.