DOCTOR'S VIEW ARCHIVE
New Treatment Possibility for MS
Medical Author: Melissa Stoppler, M.D.
FDA Public Health Advisory Suspended Marketing of Tysabri (natalizumab)
March 3, 2005, FDA is issuing this public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (natalizumab) due to two serious adverse events reported with its use. FDA has received a report from Biogen Idec, the manufacturer of Tysabri, of one confirmed, fatal case and one additional case of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for multiple sclerosis (MS). Both patients were enrolled in a long-term clinical trial and had been taking Tysabri for more than two years. There have been no previous cases of PML reported in patients taking Tysabri. For the rest of the FDA press release, please click here.