Public Health Advisory for Atomoxetine

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FDA/Center for Drug Evaluation and Research

Public Health Advisory
Suicidal Thinking in Children and Adolescents Being
Treated With Strattera (Atomoxetine)

Today the Food and Drug Administration (FDA) directed Eli Lilly and Company (Lilly), the manufacturer of Strattera (atomoxetine), to revise the labeling for this product to include a boxed warning and additional warning statements that alert health care providers to an increased risk of suicidal thinking in children and adolescents being treated with this drug. FDA also informed Lilly that it has determined that a Patient Medication Guide (MedGuide), which will advise patients of the risks associated with Strattera and precautions that can be taken, should be distributed to patients when Strattera is dispensed.

Strattera is approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adult patients.

The increased risk of suicidal thinking for this drug was identified in a combined analysis of 12 short-term (6-18 weeks) placebo-controlled trials (11 in ADHD and 1 in enuresis [bedwetting]). These 12 trials involved a total of over 2200 patients, including 1357 receiving Strattera and 851 receiving placebo. The analysis showed a greater risk of suicidal thinking during the first few months of treatment in those receiving Strattera. The average risk of suicidal thinking was about 4 per thousand patients treated with Strattera compared to no events in placebo-treated patients. There was 1 suicide attempt among these approximately 2200 patients, occurring in a patient treated with Strattera. Based on these data, FDA has determined that the following points are appropriate for inclusion in the boxed warning:

Strattera increases the risk of suicidal thinking in children and adolescents with ADHD.
Anyone considering the use of Strattera in a child or adolescent for ADHD must balance the increased risk of suicidal thinking with the clinical need for the drug.
Patients who are started on 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 prescriber.

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. This monitoring should include daily observation by families and caregivers and frequent contact with the physician.

In addition a MedGuide is being prepared for Strattera to provide directly to patients and their families and caregivers information about the increased risk of suicidal thinking in children and adolescents prescribed Strattera. The MedGuide is intended to be distributed by the pharmacist with each prescription or refill of a medication.

A similar analysis in adult patients treated with Strattera for either ADHD or major depressive disorder (MDD) found no increased risk of suicidal ideation or behavior with use of Strattera.

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.

Date created: September 29, 2005