STRATTERA LABEL REVISED, NOW WARNS OF THREAT OF SUICIDAL THOUGHTS

Eli Lilly recently announced its attention-deficit/hyperactivity disorder drug Strattera might cause increased suicidal thoughts among children and adolescents, leading the FDA to issue a health advisory and the company to update the drug's label.

Lilly discovered, through a study of its clinical trial database, a small, but statistically significant, increase in suicidal thoughts among Strattera-treated children and adolescents. According to that study, there was an increase in such thoughts in five cases out of 1,357 patients, or 0.4 percent, versus zero cases out of 851 patients taking a placebo. There also was one case of a suicide attempt by a patient taking Strattera, the firm said.

But the company found no suicides among children, adolescents or adults on the medication during any Strattera clinical trials, and there was no indication of an increased risk of suicidal thinking in the adult population.

The FDA, which requested the Strattera study, issued a public health advisory Sept. 29 to alert doctors of the finding. The agency is advising doctors that children and adolescents taking 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 (either increased or decreased)."