FDA Approves Updated Safety Labeling for Strattera

The FDA has approved updated safety labeling for Strattera® to include information regarding use of Strattera in patients with ADHD who have a comorbid tic disorder.

The U.S. Food and Drug Administration (FDA) has approved updated safety labeling for Strattera (atomexetine HCI), the non-stimulant attention deficit disorder (ADD ADHD) medication, to indicate that it does not worsen tics in patients with both ADHD and a tic disorder such as Tourette’s syndrome.

The label update was based on a placebo-controlled study of 148 pediatric patients with ADHD and a tic disorder.

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