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    Increased risk of suicidal thinking in children and adolescents being treated with Strattera (Atomoxetine) September 30, 2005 - SALT LAKE CITY, UTAH - 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 healthcare providers of an increased risk of suicidal thinking in children and adolescents during the first few months of 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. Similar studies showed that adults using Strattera for either ADHD or major depressive disorder (MDD) found no increased risk of suicidal ideation or behavior.
Patients taking Strattera should not discontinue taking the medication without speaking with their physician.
As always, pharmacies and members can contact the RxAmerica Customer Service Desk at 1-800-770-8014 if they have any questions about this product recall. |
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