Topic Overview

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

The warnings are 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.footnote 1 This means that 996 out of 1,000 children did not think about suicide.

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

Also, Health Canada and the FDA have 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.

Health Canada and the FDA do not advise people to stop taking Strattera. But people who take this medicine should be watched for signs of suicidal thinking.

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  1. U.S. Food and Drug Administration (2005). FDA issues public health advisory on Strattera (atomoxetine) for attention deficit disorder. FDA News P05-65. Available online:


ByHealthwise Staff
Primary Medical Reviewer Adam Husney, MD - Family Medicine
Thomas M. Bailey, MD - Family Medicine
Specialist Medical Reviewer Louis Pellegrino, MD - Developmental Pediatrics

Current as ofNovember 20, 2015