Warning on Liver Injury from Strattera

This is from 2005, and REGULAR blood tests should be given to patients on Strattera to make sure the drug is not damaging ther patient.

FDA is advising health professionals about a new warning for the drug Strattera, used to treat attention deficit hyperactivity disorder in adults and children.

The drug's labeling is being updated with a bolded warning about the potential for severe liver injury in patients taking Strattera. The label warns that severe liver injury can progress to liver failure in a small percentage of patients. It cautions clinicians to discontinue the drug in patients who develop jaundice or laboratory evidence of liver injury. It also notes that the actual number of cases of severe liver injury from the drug is not known because of under-reporting.

Strattera's manufacturer, Eli Lilly, has agreed to send a letter to physicians, alerting them to the new information. The company will also update the patient package insert to include information about the signs and symptoms of liver problems.

If you learn of unexpected adverse events with Strattera, including liver damage, please report them, either directly to Eli Lilly, or to FDA's MedWatch program.