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)."
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