first PML case on tecfidera

Discuss Tecfidera (BG-12, dimethyl fumarate) as an oral treatment for multiple sclerosis.

first PML case on tecfidera

Postby centenarian100 » Wed Oct 22, 2014 4:36 pm

Caveat emptor

http://www.reuters.com/article/2014/10/ ... 9720141022

Biogen reported the first case of progressive multifocal leukoencephalopathy (PML) in a Tecfidera patient, who had been part of a clinical trial and was taking the drug for 4-1/2 years.

The patient, who died of pneumonia, had been suffering severe lymphopenia, a low white blood cell condition, for more than three years, which Biogen said was a risk factor for developing PML.

Biogen, which has notified health regulators of the PML case, said 100,000 patients have taken Tecfidera.
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Re: first PML case on tecfidera

Postby MSUK » Fri Oct 31, 2014 1:41 am

Patient taking MS drug Tecfidera dies of rare brain infection

Biogen Idec Inc., maker of the popular multiple sclerosis (MS) pill dimethyl fumarate (Tecfidera), announced the death of a patient taking the drug who succumbed to complications from a rare brain infection. Executives broke the news during a conference call with analysts last Wednesday.

The brain infection known as progressive multifocal leukoencephalopathy (PML) took the life of a European patient who had been on the popular pill for more than four years. The patient was taking part in a long-term safety study of Tecfidera........... Read More - http://www.ms-uk.org/tecfidera
MS-UK - http://www.ms-uk.org/
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Re: first PML case on tecfidera

Postby Bender » Wed Nov 05, 2014 10:34 am

I wonder what drugs they were on before they started tecfidera?

it may have said I totally TLDRed, my doctor told me about this. that said I was on tysabri and did a course of ritxan so I need to continue to have JC antibodies tests either way.... yea!
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Re: first PML case on tecfidera

Postby ursula » Fri Nov 21, 2014 7:43 am

The woman took part in the approval study in germany. They let her walk around with severe lymphopenia for more than 3 years!
There were no other risk factors as explanation for the PML.
So it looks like if Tecfidera is the only reason for this unnecessary case of death.
Biogen had admitted that lymphopenia is a known risk für PML long ago (-> fumaderm) . But no warnings in the package insert and for doctors!
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