Monday, October 24, 2005

New Black Box Warning for Strattera: Suicide Risk

This just out from the FDA: there is a higher rate of suicide risk for children taking the drug Strattera. From USA Today:

"Lilly began sending out notices about the warning Thursday to doctors, patients and the public. The notices urge "appropriate vigilance" for signs of suicidal thoughts among children taking the drug, said Dr. John R. Hayes, vice president of Lilly Research Laboratories...Strattera was Lilly's sixth best-selling drug last year with $667 million in sales. It treats attention-deficit and hyperactivity disorder, which affects 3% to 7% of school-age children and shows up as an inability to concentrate, high distractibility and impulsivity.

The warning comes after Lilly responded to an FDA request to reanalyze its data on 1,357 children and adolescents who took Strattera in placebo-controlled clinical trials to test the drugs years ago. Five children, or 0.4%, reported suicidal thoughts while taking the drug, including one child who attempted suicide, Lilly said. Among the control group of 851 children who took a placebo, or sugar pill, in the trials, none had suicidal thoughts, Lilly said."

USA Today: Strattera Suicide Risk
FDA Public Health Advisory on Strattera - ADD / ADHD

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