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U.S. Department of Health and Human Services

Safety

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Strattera (atomoxetine) Sep 2005

Audience: Neuropsychiatric and other healthcare professionals, consumers

[Posted 09/29/2005] The FDA directed Eli Lilly and Company (Lilly), the manufacturer of Strattera (atomoxetine), to revise the prescribing information to include a boxed warning and additional warning statements that alert health care providers of an increased risk of suicidal thinking in children and adolescents being treated with this medication. FDA also informed Lilly that a Patient Medication Guide (MedGuide) should be provided to patients when Strattera is dispensed. The MedGuide advises patients of the risks associated with and precautions that can be taken when Strattera is dispensed. Further, pediatric patients being treated with Strattera should be closely observed for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

[September 29, 2005 - Public Health Advisory - FDA]
[September 29, 2005 - Press Release - FDA]
[September 29, 2005 - Drug Information Page - FDA]
[September 29, 2005 - Healthcare Professional Information Sheet - FDA]