Reuters Health Information (2008-03-21): EU follows U.S. with Tysabri liver warning
EU follows U.S. with Tysabri liver warning
Last Updated: 2008-03-21 9:45:13 -0400 (Reuters Health)
LONDON (Reuters) - The European Medicines Agency said on Thursday that warnings about liver injury should be added to the product information for Biogen Idec Inc and Elan Corp Plc's multiple sclerosis drug Tysabri.
The move follows a similar move by the U.S. Food and Drug Administration earlier this year.
The European watchdog said doctors should monitor the liver function of patients receiving Tysabri and patients who observe any signs of liver injury should see their doctor.
Tysabri has been haunted by safety concerns since it was approved.
Sales of the drug were suspended in 2005 amid three cases of progressive multifocal leukoencephalopathy, or PML. The drug returned to the market in 2006 with limits after the FDA decided that MS patients were willing to accept the risks in light of possible benefits.