FDA Issues Public Health Advisory on Strattera (Atomoxetine) for Attention-deficit/Hyperactivity Disorder

The U.S. Food and Drug Administration (FDA) has issued a public health advisory to alert physicians of reports of suicidal thinking in children and adolescents associated with Strattera (atomoxetine), a drug approved to treat attention-deficit/hyperactivity disorder (ADHD). The FDA also has directed Eli Lilly and Company, manufacturer of Strattera, to develop a medication guide for patients and caregivers.

The FDA is advising health care providers and caregivers that children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed (either increased or decreased). Patients and caregivers who have concerns or questions about these symptoms should contact their health care provider.

The advisory follows a review and analysis of 11 clinical trials conducted in children with ADHD and one trial in children with enuresis (bedwetting) that identified an increased risk of suicidal thinking for Strattera. There was one suicide attempt by a patient who received Strattera among the approximately 2,200 patients in the trial. As part of a larger evaluation of psychiatric drugs and suicidality, the FDA had requested that the manufacturer conduct a review of its database and clinical trials, which included more than 2,200 patients—1,350 patients receiving Strattera and 851 receiving a placebo. The analysis showed that 0.4 percent of children treated with Strattera reported suicidal thinking compared to no cases in children treated with the placebo.

Strattera, manufactured by Eli Lilly, has been on the market since 2002 and has been used in more than 2 million patients.

Source U.S. Food and Drug Administration
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