Topic Overview

The U.S. Food and Drug Administration (FDA) has sent out an advisory on the medicine Strattera (atomoxetine). This medicine may be used to treat attention deficit hyperactivity disorder. Taking this drug may increase the risk of thinking about suicide in children.

The FDA warning is based on studies of 2,200 children. One child who was taking Strattera tried to kill himself. Other studies showed that 4 out of 1,000 children treated with Strattera thought about killing themselves.¹ This means that 996 out of 1,000 children did not think about suicide.

Doctors and caregivers are advised to watch for any behavior changes in children and teens taking Strattera. Parents and patients should discuss with the doctor any changes in behavior. These include increased agitation, irritability, or suicidal thinking. This is especially important at the beginning of treatment or when doses are changed.

Also, the FDA has asked the maker of Strattera, Eli Lilly and Company, to add a boxed warning to its label and to develop a medicine guide that includes this new risk information. With each prescription or refill of Strattera, pharmacists will give the medicine guide to patients, families, and caregivers.

The FDA does not advise people to stop taking Strattera but to watch for signs of suicidal thinking.