Jan 10, 2005: What is the New Warning for Strattera?

Strattera (atomoxetine HCl) is a selective norepinephrine reuptake inhibitor that is FDA-approved for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Mechanism of action is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter.

This drug is not labeled as a stimulant under the Controlled Substances Act. It has been on the market since 2002 and has been administered to more than 2 million patients.

Recently the FDA has advised health care professionals about a new warning for Straterra. The labeling is now "bolded" about the potential for severe liver injury. The labeling warns that severe liver injury may progress to liver failure resulting in death or the need for a liver transplant. The labeling indicates the drug should be discontinued in patients who develop jaundice or lab evidence of liver injury.

This labeling is a result of two reports (a teenager and an adult) who developed "liver injury" after being treated with Strattera for several months. Both recovered. Bold warnings have to be in prescribing information, as opposed to black box warnings which must be included in all advertisings or write-ups about the drug. The FDA determines whether the warning is a black box or bolded.

Under-reporting of post-marketing adverse events usually occurs. Even so, this is an extremely small number of patients with liver injury. The reports to the FDA are frequently very difficult to interpret as so much information may be missing. This report should heighten our awareness. It does not appear to require a change in prescribing practice.

Thanks to Dr. Keown for the question.

As always, if there are any questions, call the Tennessee Poison Center at 1-800-222-1222.

I am interested in any questions that you would like answered in "Question of the Week." Please email me with any suggestions at donna.se er ®vanderbilt.edu.

Donna Seger, M.D.

Medical Director, Tennessee Poison Center