FDA issues advisory for ADHD drug
■ A black-box warning results from reports of suicidal thinking among a small number of children who took the medication.
By Stephanie Stapleton — Posted Oct. 17, 2005
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The Food and Drug Administration issued a public health advisory Sept. 29 regarding Strattera (atomoxetine), a medication for attention-deficit/hyperactivity disorder, to alert physicians about reports of suicidal thinking associated with this drug among children and adolescents.
Strattera, on the market since 2002 and used by more than 2 million patients, is currently approved to treat ADHD in children, adolescents and adults. It has not been studied in those younger than 6.
The FDA is advising physicians to closely monitor children and adolescents being treated with this drug, especially during the initial months of therapy when the dosage is often increased or decreased. Warning signs to watch for are clinical worsening, agitation, irritability, suicidal thinking and unusual changes in behavior.
Additionally, the agency directed manufacturer Eli Lilly to revise the drug's labeling to include a boxed warning. The company, according to a statement, is working with the FDA to finalize this content. It will also work with the agency to develop a medication guide for patients and caregivers.
"Lilly's top priority is to help doctors, patients and their families make informed treatment decisions, so we are reaching out extensively to educate physicians and the public about this product label change," said Alan Breier, MD, vice president and chief medical officer at Lilly, in a statement. Also important, he added, "is that Lilly continues to view Strattera as a safe and effective treatment option."
As part of a larger evaluation of psychiatric drugs and suicidal tendencies, the FDA requested that Lilly conduct a review of its database and clinical trials -- 1,357 patients receiving Strattera and 851 on placebo. The analysis showed that 0.4% of children treated with Strattera -- a small but statistically significant amount -- reported suicidal thinking compared with no cases from the placebo group. There was one suicide attempt by a patient taking the medication. But no indication of an increased risk in the adult population has been shown.