FDA Warns About ADHD Drug Strattera

The Food and Drug Administration warned doctors Thursday about reports of suicidal thinking in some children and adolescents who are taking Strattera, a drug used to treat attention deficit hyperactivity disorder.

Manufacturer Eli Lilly & Co. announced that a black-box warning will be added to the drug’s label in the United States. Such a warning is the most serious that can be added to a medication’s label, and similar warnings will be added to the drug’s labels in other countries. The company said a study showed instances of suicidal thinking were rare.

In a statement, the FDA said it “is advising health care providers and caregivers that children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed.”

Eli Lilly said it provided the FDA results from Strattera clinical trials of 1,357 patients that found five youths taking the medication reported having suicidal thoughts, while none of 851 patients taking a placebo reported having any. One young person taking Strattera attempted suicide, but survived, company and FDA officials said.

There was no evidence of increased suicidal thoughts in adults taking Strattera, which also goes by the generic name atomoxetine, the Indianapolis-based company said.

Dr. John Grohol is the CEO and founder of Psych Central. He is an author, researcher and expert in mental health online, and has been writing about online behavior, mental health and psychology issues -- as well as the intersection of technology and human behavior -- since 1992. Dr. Grohol sits on the editorial board of the journal Cyberpsychology, Behavior and Social Networking and is a founding board member and treasurer of the Society for Participatory Medicine.

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    Last reviewed: By John M. Grohol, Psy.D. on 30 Sep 2005
    Published on PsychCentral.com. All rights reserved.