NEWS - FDA orders update of warning of brain infection (PML) with MS drug Tysabri (natalizumab)

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U.S. warns of risk rise with more Tysabri infusions

Richwine

WASHINGTON

Fri Feb 5, 2010 1:34pm EST

WASHINGTON (Reuters) - The risk of a potentially fatal brain disorder

with Biogen Idec Inc's multiple sclerosis drug Tysabri increases as

patients receive more infusions, U.S. health officials warned on

Friday.

The prescribing instructions for Tysabri will be updated to warn of

the higher risk with more treatment, the Food and Drug Administration

said. Elan Corp co-markets the drug.

The FDA said the warning was based on 31 confirmed cases of

progressive multifocal leukoencephalopathy (PML), a brain infection

that can be fatal. Eight patients have died.

" Based on the available information, the FDA believes that the

clinical benefits of Tysabri continue to outweigh the potential

risks, " the FDA said in a notice on its website.

Tysabri was temporarily withdrawn from the market in 2005 because of

its link to PML.

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Read the full article here:

http://www.reuters.com/article/idUSTRE6144G420100205

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