FDA adds rare brain infection link to Tecfidera label

[MSUK]

FDA adds rare brain infection link to MS drug Tecfidera labelling

The death from a serious brain infection of a patient taking Biogen Idec's big-selling oral multiple sclerosis therapy Tecfidera has prompted an update to the drug's label in the US.

The FDA issued a notice describing the case of a patient on Tecfidera (dimethyl fumarate) who developed progressive multifocal leukoencephalopathy (PML), the same condition that caused Biogen Idec's injectable MS therapy Tysabri (natalizumab) to be temporarily suspended from sale in 2005....... Read More - http://www.ms-uk.org/tecfidera

[NHE]

Here is the FDA's official safety announcement.

http://www.fda.gov/downloads/Drugs/Drug ... 424634.pdf