Lilly adds suicide risk to Strattera

September 29, 2005

SSRI-Research@

Thu, 29 Sep 2005 09:19:24 -0400

[sSRI-Research] Lilly adds suicide risk to Strattera

24 minutes ago

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.

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