FDA says it confirmed new cases of brain inflammation linked to MS drug, bringing total to 13
By APTuesday, September 22, 2009
FDA confirms 3 new infections linked to Tysabri
NEW YORK — The Food and Drug Administration says it confirmed three new cases of a potentially lethal brain inflammation linked to the multiple sclerosis drug Tysabri.
There have been 13 reported cases of progressive multifocal leukoencephalopathy, or PML, since mid-2006. The reports are the first confirmed new cases since June. While the disease is rare, the FDA says the risk appears to increase as patients remain on Tysabri.
Tysabri is marketed by Biogen Idec Inc. and Elan Corp. PLC, for multiple sclerosis and Crohn’s disease. All the PML cases are linked to its use in multiple sclerosis.
The drug was approved in November 2004 and pulled from the market the next year due to PML reports. It was reintroduced in July 2006, and Biogen said it is used by 43,000 patients.
