Warning on Strattera
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Warning on Strattera
The U.S. Food and Drug Administration has sent out a 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 in 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.
Health professionals and caregivers are advised to watch for any behavior changes in children and teens taking Strattera. Parents and patients should discuss any changes in behavior with the child’s doctor. These include increased agitation, irritability, or suicidal thinking. This is especially important at the beginning of treatment or when doses are changed.
In addition, 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. Pharmacists will give the medication guide to patients, families, and caregivers with each prescription or refill of Strattera.
The FDA does not advise people to stop taking Strattera but to watch for signs of suicidal thinking.
References
Citations
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: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01237.html.
Credits
| Author | Sabra L. Katz-Wise |
| Editor | Susan Van Houten, RN, BSN, MBA |
| Associate Editor | Pat Truman |
| Associate Editor | Terrina Vail |
| Primary Medical Reviewer | Michael J. Sexton, MD - Pediatrics |
| Specialist Medical Reviewer | Mina Dulcan, MD - Child and Adolescent Psychiatry |
| Last Updated | May 31, 2006 |
| Last updated: | May 31, 2006 |
|---|---|
| Author: | Sabra L. Katz-Wise |
| Reviewed By: | Michael J. Sexton, MD - Pediatrics, Mina Dulcan, MD - Child and Adolescent Psychiatry |
| Editors: | Susan Van Houten, RN, BSN, MBA, Terrina Vail |
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