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