Eli Lilly and Co. said Thursday it will add a warning to its attention deficit medication Strattera that the drug could increase suicidal thoughts among youths.
The warning will be added to Strattera labels worldwide, but Lily said reports of suicidal thoughts by children and adolescents taking the drug were rare.
Details on the labeling are being worked out with the U.S. Food and Drug Administration, along with regulators in Europe and Australia, the Indianapolis-based company said.
Lilly submitted to the FDA results from a Strattera clinical trial of 1,357 patients that found five youths taking the medication had increased suicidal thoughts, while none of 851 patients taking a placebo showed such changes, the AP reports.
About 5 million U.S. children, or 7 percent, are diagnosed with ADHD, a disorder marked by inattentiveness and impulsive behavior. Recently, some doctors have said ADHD is over diagnosed, partly to keep active children calm in the classroom. The global ADHD market is about $1.7 billion, according to Bloomberg.
It's unclear if the risks apply to other ADHD drugs, such as Shire Pharmaceuticals Group Plc's Adderall, Novartis AG's Ritalin and Johnson & Johnson's Concerta. Those drugs work as stimulants. Strattera, the first of its class approved for sale, works by blocking the body's absorption of the chemical norepinephrine in the brain, leaving more of it to help control attention and activity levels. AM