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MedWatch – Strattera and Increased Risk of Suicidal Thinking
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
September 30 , 2005

The The U.S. Food and Drug Administration (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.

The 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.

Read the complete MedWatch 2005 Safety Summary, including a link to the FDA Public Health Advisory and Press Release, FDA Drug Information Page, Healthcare Professional Information Sheet, and FDA Patient Information Sheet: http://www.fda.gov/medwatch/safety/2005/safety05.htm#Strattera

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