The U.S. Food and Drug Administration has issued an advisory to health officials concerning the drug Strattera. Straterra is given to children and adults diagnosed with attention deficit hyperactivity disorder (ADHD). The label on the drug is being updated with a bolded warning about the potential for severe liver injury. The label warns that severe liver injury may lead to liver failure resulting in death or the need for a liver transplant. The label also mentions that the number of actual cases of severe liver injury may be higher than previously thought, due to under-reporting.

The warning states that patients taking the medication who develop jaundice (yellowing of the skin or whites of the eyes) should stop taking Strattera. The FDA asked the manufacturer, Eli Lilly, to add the warnings. Eli Lilly will also update the patient package insert with information about the signs and symptoms of liver damage, which include:

• Pruritus (itchy skin)
• Jaundice
• Dark urine
• Upper right-sided abdominal tenderness
• Unexplained “flu-like” symptoms