Wednesday, June 22, 2011

In the EU, Tysabri gets an updated Warning

Progressive_multifocal_leukoencephalopathy (PML)Image via Wikipediathat European Union regulators have expanded the warning label on their multiple sclerosis drug Tysabri to help identify patients who are at risk for a dangerous brain inflammation.

The companies said the European Commission approved a warning that says patients who have an antibody to a common virus called JC Virus. The antibody indicates they have been infected with the virus. Patients who have JC Virus and severe immune deficiencies have a greater risk of developing a potentially deadly brain infection called progressive multifocal leukoencephalopathy. Tysabri also increases the risk of that infection.

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