Law Articles

Return to Law Dictionary Index

Strattera Linked to Suicidal Thinking in Children

Source: U.S. Food and Drug Administration

Strattera, an attention deficit hyperactivity disorder drug, may increase suicidal thinking in children and adolescents, the Food and Drug Administration warned on Thursday.

"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)," the FDA said in a Public Health Advisory.

The warning follows a review and analysis of clinical trials conducted in children with ADHD that identified an increased risk of suicidal thinking for Strattera. There was one suicide attempt by a patient who received Strattera among nearly 2,200 patients in the trial. The analysis showed that 0.4% of children treated with Strattera reported suicidal thinking compared to no cases in children treated with the placebo.

Manufacturer Eli Lilly and Co. said last week it will add a "black box" warning to the Strattera label and is working with the FDA to finalize the product label content as well as information for healthcare professionals.

Strattera is the only non-stimulant drug approved for the treatment of ADHD. It has been on the market since 2002 and has been used in more than two million patients. Sales for Strattera topped $667 million last year.

Read Full Story at U.S. Food and Drug Administration

Return to Health Law

Return to Law Dictionary Index