The FDA has issued a public health advisory regarding Tysabri (natalizumab).The FDA has issued a public health advisory regarding Tysabri (natalizumab), a mix with drugs approved in November 2004 to convert into the frequency of multiple sclerosis (MS) attacks in nation with relapsing forms of MS The put drugs into manufacturer, Biogen Idec of Cambridge, Mass., voluntarily suspended marketing of Tysabri in February 2005 appropriate to two serious adverse results reported with its use. brace confirmed cases, including one fatal, of progressive multifocal leukoencephalopathy (PML) in populace receiving Tysabri for MS were reported to the FDA. PML is a rare progressive fortitude disease that can occur in persons whose immune systems are strangleed It often results in irreversible neurologic deterioration and death. Although the relationship between Tysabri and PML is not clear, because of the serious nature of PML the FDA concurr with the manufacturer that it voluntarily withdraw the physic from marketing and suspend the use of Tysabri in clinical trials until more is known. No previous cases of PML have been reported in the approximately 3000 folks who have taken Tysabri in clinical trials. The brace serious adverse events occurred in nation taking the drug in postmarketing studies required on the FDA. Both patients had been taking Tysabri for more than brace years. folks being treated with Tysabri should discontinue its use and contact their physicians to discuss appropriate alternative treatments. The FDA is working with the manufacturer to determine the best way s for assessing people who have received Tysabri in order to assure their safety and understand the connection, if any, between Tysabri and PML The FDA will provide further information as it becomes available. For more information, view www.fda.gov/cder/drug/ infopage/natalizumab/ COPYRIGHT 2005 U command Printing Office |
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