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Strattera Gets Stronger Label Warning

Prompted by two reports of severe liver injury among the more than 2 million patients who have taken atomoxetine (Strattera) for attention-deficit/hyperactivity disorder (ADHD), Eli Lilly and Co., in cooperation with the U.S. Food and Drug Administration (FDA), will add a bolded warning to the drug's label immediately.

"Patient safety is our top priority at Lilly," said Douglas Kelsey, M.D., a clinical research physician at Lilly and a pediatrician, in a prepared statement. "When we learned of the first case, we reported it to the FDA and began a thorough investigation, including consultation with outside experts and a review of all available data."

The company worked closely with the FDA to determine what action to take. Lilly will notify health care professionals in a "Dear Doctor" letter. Patients will be informed that they should contact their doctor immediately if they develop pruritus, jaundice, darkened urine, upper-right-sided abdominal pain or tenderness, or any unexplained "flu-like" symptoms.

The company's review concluded that "the clinical trial and real-world data indicate that the benefit-risk profile for Strattera is positive, and the medication continues to be an important treatment option for patients with ADHD."

In more than 6,000 patients taking atomoxetine during clinical trials, no cases of liver injury were noted. Lilly's statement stresses that although only two postmarketing cases have been reported, "because of probable underreporting, it is impossible to provide an accurate estimate of the true incidence of these events."

The statement goes on to say that "even when accounting for underreporting, real-world incidence of liver injury among patients taking the medication is less than the rate expected for the overall population."

More information is available by calling the Lilly Answers Center at (800) or LillyRx at (800) 545-5979 or online at <www.strattera.com>.

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