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Suicide Tendencies 
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Children and Teen Suicide Tendencies from Strattera for ADHD
In September 2005, the Food and Drug Administration directed Eli Lilly and Company, the maker of Strattera (atomoxetine), to revise the labeling to include a boxed warning and additional warning statements that alert healthcare providers of an increased risk of suicide thinking in children and adolescents being treated by Strattera. The FDA also informed Lilly that parents should be notified of the risks associated with Strattera and precautions that can be taken at the time Strattera is dispensed.
Has your son or daughter had thoughts of suicide from taking Strattera?
The increased Strattera risk of children and teens for thoughts of suicide was identified in a combined analysis of 12 short-term (6-18 weeks) placebo-controlled trials (11 in ADHD and one for bedwetting. The 12 trials involved a total of over 2,200 children and teens, including 1,357 who received Strattera and 851 who received placebo. The analysis showed a greater risk of thoughts of suicide during the first few months of treatment in those receiving Strattera. The average risk of suicidal thinking was about 4 per thousand treated with Strattera compared to no events in placebo-treated patients. There was one suicide attempt among approximately 2,200 patients, occurring in a child treated with Strattera. Labeling was advised to convey:
- Strattera increases the risk of thoughts of suicide in children and adolescents with ADHD.
- Anyone considering the use of Strattera for a child or adolescent with ADHD must balance the increased risk of suicidal thinking with the clinical need for the drug.
- Children and teens who already started on Strattera therapy should be observed closely for clinical worsening, suicidal thinking or behaviors, or unusual changes in behavior.
- Families and caregivers should be advised to closely observe the patient and to communicate changes or concerning behaviors with the doctor.
Pediatric patients being treated with Strattera should be closely observed for clinical worsening plus agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of starting Strattera, or when the dosage increases or decreases. Monitoring should include daily observation by families and caregivers and frequent contact with the doctor.
Additionally, a MedGuide should be provided to parents of Strattera patients regarding the increased risk of suicidal thinking in children and adolescents prescribed who take the drug. The MedGuide should be distributed by the pharmacist with each prescription or refill of a medication.
Adults who are being treated with Strattera for ADHD did not show suicidal tendencies.
FDA plans to work closely with Lilly to optimize the safe use of this drug and implement the proposed labeling changes and other safety communications in a timely manner.
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