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FDAnews Drug Daily Bulletin
Nov. 3, 2009 | Vol. 6 No. 214
EMEA: Another Tysabri Patient Develops PML, Brings Total to 24
A new progressive multifocal leukoencephalopathy (PML) infection has been confirmed in a patient taking Tysabri, Biogen Idec and Elan’s multiple sclerosis drug, bringing the number of cases to 24 — four of them fatal, the European Medicines Agency (EMEA) says. Fourteen of the PML brain infection cases have occurred in the EU, eight in the U.S. and two in Switzerland since the drug’s reintroduction in 2006, EMEA spokeswoman Vladimira Yalmanova said.
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