Safety alert
date: 9/30/2005
New warning on attention-deficit drug
Parents should be alert to danger signs in children and teens who are taking Strattera for attention deficit hyperactivity disorder.
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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:
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
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