Warnings, Columns-Drugs & Supplements, February 2005

WASHINGTON, D.C. - The Food and Drug Administration issued a public health advisory on Feb. 25, warning patients and healthcare providers about the suspended marketing of Tysabri (nataluzimab) while the agency and the manufacturer evaluate two serious adverse events reported with its use.

FDA received a report from Biogen Idec, the manufacturer of Tysabri, of one confirmed fatal case and one possible case of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for MS. FDA was given preliminary information …