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Tysabri's Liver Warning Expanded to MS Patients

By JENNIFER CORBETT DOOREN
February 28, 2008; Page D4

Biogen Idec Inc. and Elan Corp. warned doctors of the possibility of
serious liver injury in patients being treated with the multiple-sclerosis
drug Tysabri.

The new warning, in a letter posted on the Food and Drug Administration's
Web site, was recently included in prescribing information for Tysabri use
in patients with Crohn's disease, a chronic, progressive disease marked by
inflammation of the bowel. Last month, the FDA approved Tysabri for
Crohn's patients who have failed other treatments, including Johnson &
Johnson's Remicade and Abbott Laboratories' Humira, although the drug
hasn't yet been launched as a treatment for Crohn's.

Now the same liver warning is being included in information aimed at
neurologists who treat multiple sclerosis. Tysabri was first approved as
an MS treatment in 2004 but was temporarily taken off the market in 2005
over concerns about a serious brain infection. The drug is now sold under
a restricted-distribution program, and patients are routinely monitored
for signs of the brain infection, known as progressive multifocal
leukoencephalopathy, and for other side effects.

The letter to doctors said that the companies have received "clinically
significant" reports of liver injury in patients being treated with
Tysabri, and that signs of liver injury occurred as early as six days
after the first dose of Tysabri. Liver injuries also occurred after
multiple doses of the drug.

The letter instructed doctors to tell their patients that Tysabri may
cause liver injury and said they should stop drug treatment if patients
show signs of liver injury including jaundice.

Shannon Altimari, a Biogen spokeswoman, said the rate of liver injuries is
less than one in 1,000 patients. As of the end of December, about 21,000
patients had been treated with Tysabri. None of the injuries required a
liver transplant, she said.

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@...