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Eli Lilly and Co. on Thursday said it will add strong warnings to its label for Strattera, used to treat attention-deficit/hyperactivity disorder, including the risk of suicidal thoughts among children and adolescents.
Strattera will now carry a "black box" warning, the strongest required by U.S. regulators.
Lilly said there were no suicides among children, adolescents or adults taking the medication during Strattera clinical trials, but there was one suicide attempt in a patient taking the drug.
The warning came after the U.S. Food and Drug Administration requested Lilly to submit an analysis of adverse event data from its Strattera clinical trials data base, which identified a small but statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents.
Lilly said it is working with the FDA to finalize the product label. It also is working with regulators outside the United States.
Lilly backed its prior sales and earnings outlook for the year and said it expects to report full-year 2005 earnings per share of $1.90 to $1.96.
ADHD affects 3 to 7 percent of school-age children and manifests itself in inappropriate levels of attention, concentration, activity, distractibility and impulsivity.
Shares of Lilly closed at $53.47 on Wednesday on the New York Stock Exchange.
Strattera will now carry a "black box" warning, the strongest required by U.S. regulators.
Lilly said there were no suicides among children, adolescents or adults taking the medication during Strattera clinical trials, but there was one suicide attempt in a patient taking the drug.
The warning came after the U.S. Food and Drug Administration requested Lilly to submit an analysis of adverse event data from its Strattera clinical trials data base, which identified a small but statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents.
Lilly said it is working with the FDA to finalize the product label. It also is working with regulators outside the United States.
Lilly backed its prior sales and earnings outlook for the year and said it expects to report full-year 2005 earnings per share of $1.90 to $1.96.
ADHD affects 3 to 7 percent of school-age children and manifests itself in inappropriate levels of attention, concentration, activity, distractibility and impulsivity.
Shares of Lilly closed at $53.47 on Wednesday on the New York Stock Exchange.
