The FDA has issued a warning about Strattera (atomoxetine), a drug used to treat attention deficit hyperactivity disorder (ADHD) in adults and children.
They have required that the labeling be updated to include a bolded warning about the potential for severe liver damage. Two patients using Strattera for several months, have suffered severe liver damage, but fortunately have recovered.
The new labeling warns that severe liver injury may progress to liver failure and death. It also warns that the medication should be discontinued in patients who develope jaundice.
Strattera has been in use since 2002. Clinical trials comprising 6,000 people turned up no ill side effects.
Signs of liver failure include: itchy skin, jaundice, dark colored urine, upper right side abdominal tenderness and unexplained "flue-like" symptoms.
