December 17, 2004 INDIANAPOLIS (AP) -- Drug maker Eli Lilly & Co. warned doctors Friday to stop using the attention deficit disorder drug Strattera in patients with jaundice or who show signs of liver problems.
Lilly placed a boldface warning on the label and in prescribing information for the drug to alert doctors after at least two patients on the medication developed liver problems. Both patients recovered normal liver function after stopping the medication, the Indianapolis-based company said.
It said more than 2 million patients have taken the Strattera since it reached the market last year.
"They were two cases that the FDA felt were drug-related and that we felt were drug-related as well," Lilly spokeswoman Jennifer Bunselmeyer said.
However, other patients also may have suffered liver problems. The new boldface warning, also posted on the drug's Web site, tells doctors that Lilly probably has not received reports of all such cases.
Neither of the patients in the two cases cited required a liver transplant, the warning said.
"However, in a small percentage of patients, severe drug-related liver injury may progress to acute liver failure resulting in death or the need for a liver transplant," it said.
An FDA spokeswoman did not immediately return a message seeking comment from The Associated Press.
Patients taking Strattera should contact their doctor immediately if they develop jaundice, itchy skin, dark urine, tenderness in the upper right side of their abdomens or unexplained flu-like symptoms, Lilly said.
The liver problems did not show up in clinical trials with about 6,000 patients who took Strattera, which, unlike most other ADD medications, is not a stimulant.
Some investment analysts have forecast Strattera could top $1 billion in annual sales by 2006. Its sales totaled $163.6 million during the three-month period that ended Sept. 30.
Lilly shares were down $1.90, or 3.3 percent, to $55.50 in afternoon trading on the New York Stock Exchange. The stock reached a 52-week low of $50.34 in late October.
Parents or patients with additional questions can call 1-800-LillyRx or visit the product's Web site at www.strattera.com.
Copyright 2004 The Associated Press. All rights reserved.
