Strattera Liver Injury Reports Continue to be Received by FDA

Although information is already listed on the warning label for Strattera about potential side effects which may cause liver problems, the FDA continues to receive reports of users taking the medication who develop serious liver injury.

Strattera (atomoxetine), which is manufactured by Eli Lilly & Co, was approved by the FDA in November 2002, for treatment of attention deficit hyperactivity disorder (ADHD) in adults and children aged 6 years and above.

Between 2002 and 2007, about 3.3 million people were prescribed Strattera, and over 2 million were children under 18 years old.

Following post-marketing reports, the warning label for the medication was updated in 2004 to indicate that Strattera side effects could led to severe liver injury, which may progress to liver failure resulting in death or the need for a liver transplant in a small number of patients.

The bolded warning indicates that the medication should be discontinued in patients who develop jaundice, which involves a yellowing of the skin or whites of the eyes, or who have laboratory evidence of liver injury while taking Strattera.

According to the most recent FDA Drug Safety Newsletter released earlier this month, reports of serious liver injury in Strattera users continue to be received by the FDA.

The article, which is part of a newsletter designed to provide postmarketing information to healthcare providers about drug safety and to raise awareness of reported adverse events, provides a review of six cases of Strattera liver injury submitted to the FDA between January 2005 and March 2008. None of the patients required liver transplants, but one adult did die, though the role of Strattera in the death was unclear.

Drug induced liver injury is the most common reason for acute liver failure in the United States. A drug may cause chemical damage to liver cells which can result in serious injury to the liver and may cause death. Signs of liver damage may include nausea, jaundice, vomiting, bleeding, abdominal pain or mental confusion. Kidney failure may also be present in some cases.

The Strattera label does have a “black-box warning” about the risk of suicidal ideation in adolescents and children, which is the strongest type of warning that can be placed on a prescription medication. However, the information about Strattera liver risks is not currently contained in the boxed warning.

The FDA recommends that healthcare providers and patients taking Strattera watch for symptoms of liver injury during and stop taking the drug if jaundice develops or any other signs of hepatotoxicity appear.