http://news.yahoo.com/news?tmpl=story&cid=534&u=/ap/20041217/ap_on_bi_ge/strattera_warning&printer=1
INDIANAPOLIS - 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 (news - web sites) 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.
The Food and Drug Administration (news - web sites) said the evidence supported Lilly’s decision.
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