Warning on Strattera for Attention-Deficit Hyperactivity Disorder
A Public Health Advisory has been issued by the FDA to alert physicians to reports of suicidal thinking in children and adolescents associated with Strattera (atomoxetine). Strattera is approved to treat attention-deficit hyperactivity disorder (ADHD).
The FDA is advising health care providers, parents, and other caregivers to closely monitor children and adolescents being treated with Strattera. Patients should be monitored for worsening symptoms including agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior. Special attention should be paid to symptoms during the first few months of therapy or when the drug dose is increased or decreased. Caregivers and those taking Strattera who have concerns or questions about these symptoms should contact their health care provider.
The FDA also has directed the manufacturer of Strattera, Eli Lilly and Co. of Indianapolis, to develop a Medication Guide for patients and caregivers. The Medication Guide is intended to be distributed by the pharmacist with each prescription or refill of the drug. …