The Food and Drug Administration (FDA) has put out a bolded warning for severe liver injury after taking Strattera, a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and children.

The labeling warns 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. The labeling also notes that the number of actual cases of severe liver injury is unknown because of underreporting of post-marketing adverse events.

The bolded warning indicates that the medication should be discontinued in patients who developed yellowing of the skin or whites of the eyes, or laboratory evidence of liver injury.

The company was asked to update the patient package insert with information about the signs and symptoms of liver problems, which include:

Pruritus (Itchy skin)
Jaundice
Dark urine
Upper right-sided abdominal tenderness
Or unexplained "flu-like" symptoms

For more information call the consumer information of the FDA 888-INFO-FDA