Business - AP
Fri Dec 17, 5:40 PM ET
By Ken Kusmer, AP Business Writer
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.
"There's pretty good evidence from the two cases they we know of that the drug did this," said Dr. Russell Katz, chief of neurological drugs for the FDA. Those two cases show a very small percentage of patients taking Strattera will develop liver problems. Of those that do, the problems can become life-threatening, Katz said. "The nature of the injury is very severe," Katz said. "Drugs like this can produce death or the need for liver transplant in a small percentage of patients."
In both of the cases that have come to light, the patients fully recovered after stopping the drug and without needing a liver transplant, Lilly said. However, it's possible other Strattera users also have developed liver problems, Lilly said. Such complications once a drug hits the market typically are underreported because physicians are not required to do so. Also, they might not suspect the drug as the cause of problem.
"We don't really know what the right number is of actual cases," Katz said. The two known cases involve a teenager and an adult. The teenager also was taking an antidepressant, and the doctor stopped both drugs when the patient developed liver problems. The doctor than restarted the youth just on Strattera, Katz said, and "the same thing happened, only worse." "That's fairly good evidence that the drug did it. It's not absolute proof," he said.
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.
Hemant K. Shah, an independent pharmaceutical industry stock analyst, placed the Strattera warning in the broader industry context of health complications for drugs long on the market. Pfizer Inc. said Friday it had found an increased risk of heart attacks for patients taking high dosages of its painkiller Celebrex, the same problem that led Merck & Co. to withdraw Vioxx from the market.
"These things happen all the time. It's getting more scrutiny because of the environment we live in," Shah said.
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 slipped $1.38, or 2.4 percent, to close at $56.02 on the New York Stock Exchange (news - web sites). 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.