• Parents should be alert to danger signs in children and teens who are taking Strattera for attention deficit hyperactivity disorder.

On September 29, 2005, the Food and Drug Administration (FDA) alerted physicians and consumers that the drug atomoxetine (Strattera), a relatively new drug used to treat attention deficit hyperactivity disorder (ADHD), had been linked in studies to a higher incidence and risk of suicidal thinking among children and teenagers.

The agency advised doctors to closely monitor children and teens who are now taking the medicine, especially during the first few months of treatment or if the dose of the drug is changed. Strattera's manufacturer, Eli Lilly, will add a boxed warning on its labeling for the drug and has been directed by the FDA to develop a medication guide for patients and their caregivers.

Parents of children and teens taking Strattera should contact their doctors to discuss whether any change in treatment is needed, and what precautions to take if their child is to remain on the drug. The FDA said doctors and parents should be alert to these possible signs of problems:

• Child thinking about, talking about, or trying to commit suicide
• ADHD symptoms getting worse
• Child more agitated or irritable
• Unusual changes in a child's behavior

The FDA's action came after a new analysis of 12 clinical trials. It found that more children and teens who were taking Strattera had suicidal thoughts than those taking placebos (dummy pills). The number of children who had such thoughts was quite small, however. Less than 1 percent (0.4 percent) of those taking Strattera had thoughts of suicide. None of those taking placebos did. Among those taking Strattera, one (out of 1,350) made a suicide attempt.

next: Detailed Strattera Information

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Reviewed: 02/2006