Strattera Usage Linked to Suicidal Thoughts

September 2005

Parents beware-if your child is taking Strattera, keep a close eye on them. That’s because the Food and Drug Administration (FDA) issued a warning that children using the prescription drug Strattera for attention-deficit hyperactivity disorder (ADHD) may have bouts of suicidal thinking.

Eli Lilly & Co., Strattera’s manufacturer, is currently adding a black-box warning, the most serious FDA warning, to the drug’s label. Closely monitor children using Strattera for agitation, irritability, suicidal thoughts or behaviors, and any unusual changes in behavior, especially within the first few months of use or whenever the dosage changes.

The warning comes after of a review of 12 clinical tests showing 0.4% of children treated with Strattera reported suicidal thoughts. None of the children receiving a placebo reported suicidal thoughts. Additionally, there was no evidence of increased suicidal thoughts in adults taking Strattera.

Patients or parents concerned about Strattera use should consult their doctor before making any changes on their own.

For more information about Strattera, visit the Strattera Drug Alerts.