According to the FDA, Strattera® has been linked to liver damage
side effects in two ADHD patients. The FDA has asked the
manufacturer, Eli Lilly, to augment the drug's label with a bolded
warning about severe liver injury. The new warning label indicates
that severe liver injury may progress to liver failure resulting in
death or the need for a liver transplant in a small percentage of
patients.
Eli Lilly has warned doctors to stop prescribing Strattera® in patients with jaundice or existing liver damage. The updated warning and labeling follows reports of liver problems in an adult and a teenager who had been treated with Strattera for several
months. According to Eli Lilly, both patients recovered after
discontinuing the drug.
Strattera® is the only nonstimulant drug for
attention-deficit/hyperactivity disorder. The ADHD prescription
medication is also known as amoxetine HCl.
Two million people have used Strattera® since the U.S. FDA
approved it in November 2002 for the treatment of attention deficit
disorder in children, adolescents and adults.
