Medscape article on Strattera

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Medscape Alert

Strattera May Cause Hepatotoxicity

Dec. 20, 2004 — The U.S. Food and Drug Administration (FDA) has warned

healthcare professionals via a talk paper of changes to the safety labeling for

atomoxetine (Strattera, made by Eli Lilly), warning of the risk of

hepatotoxicity

that may be associated with its use. The FDA recommends discontinuation of

atomoxetine therapy in patients developing jaundice or laboratory evidence of

hepatotoxicity.

The bolded warning was based on reports received by the FDA of severe liver

toxicity in two patients (one adult, one teenager) who had been receiving

atomoxetine therapy for several months. Both patients recovered after

discontinuation of the drug.

Atomoxetine has been prescribed for more than two million patients since its

approval in 2002 for the treatment of children and adults with attention

deficit hyperactivity disorder (ADHD).

The new labeling warns that severe liver injury may progress to liver fai

lure, resulting in death or the need for liver transplantation in a small

percentage of patients. The actual number of incidents of hepatotoxicity

associated

with atomoxetine therapy is unknown due to the underreporting of postmarketing

adverse events. Results of premarketing clinical trials involving more than

6,000 patients did not show a link between atomoxetine and hepatotoxicity.

The updated label will include information regarding signs and symptoms of

liver injury, including jaundice, pruritis, dark urine, upper right-side

abdominal tenderness, and unexplained " flu-like " symptoms.

In addition to making the safety labeling changes, Eli Lilly will be

contacting healthcare professionals directly concerning this issue.

Healthcare professionals are encouraged to report any adverse events

associated with Strattera directly to Eli Lilly at 1-800-LillyRx.