There has been a lot of talk of BG-12 (Tecfidera) for, I don’t even know how long, but a long time. BG-12 is a new oral medication for the treatment of relapsing remitting Multiple Sclerosis (MS) (approved by the FDA on March 27th, 2013) and who’s active ingredient (dimethyl fumarate) has been linked to a rare and sometimes fatal brain disease called progressive multifocal leukoencephalopathy (PML) This active ingredient is used in another medication called Fumaderm which has been used in Germany since 1994 to treat flare ups of psoriasis (a chronic immune disorder effecting the skin). So far 4 patients taking Fumaderm have developed PML.
PML is an infection of the brain (caused by the JC Virus) that destroys the cells that produce myelin in the central nervous system (CNS). PML can cause MS-like symptoms such as weakness, paralysis, confusion, memory loss, loss of vision, and loss of speech, only PML progresses much quicker and can even be fatal. PML can be caught in time to prevent such an outcome but PML often results in permanent neurological damage which is why patients taking medication such as Tysabri (which can also cause PML and is ALSO manufactured by Biogen Idec) are checked every 3 to 6 months for PML development.
Though there have yet to be any cases of PML among patients taking BG-12 in trials, some say the trials have not been going on long enough to allow PML to develop. The worry is that if PML develops in Fumaderm (which again, has the same active ingredient as BG-12) that it will also start developing in patients taking BG-12 after some time. It is important to note that the patients taking Fumaderm who developed PML had a low white blood cell count, white blood cells are in charge of fighting infections.
Do you think that this possible PML issue is enough to kill the hype about BG-12? Would you still be willing to risk the possibility of developing PML if they made sure to monitor you like they do with Tysabri? What is with Biogen and PML?? Share your opinion below in the comments!