first PML case on tecfidera

[centenarian100]

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.

[MSUK]

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

[Bender]

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!

[ursula]

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!

[NHE]

The FDA now has a safety announcement on Tecfidera and PML.

http://www.fda.gov/Drugs/DrugSafety/ucm424625.htm

The U.S. Food and Drug Administration (FDA) is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate), developed a rare and serious brain infection called PML, and later died. As a result, information describing this case of PML, or progressive multifocal leukoencephalopathy, is being added to the Tecfidera drug label. Patients taking Tecfidera should contact their health care professionals right away if they experience symptoms that concern them, such as new or worsening weakness; trouble using their arms or legs; or changes to thinking, eyesight, strength or balance. Health care professionals should stop Tecfidera if PML is suspected.

Tecfidera has been shown to benefit patients with relapsing forms of MS. This type of MS causes attacks or relapses – periods of time when symptoms get distinctly worse.

The patient who died was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML. This is the only confirmed case of this rare and serious brain infection reported in patients taking Tecfidera.

PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems. Symptoms of PML are diverse and may include progressive weakness on one side of the body, clumsiness, vision problems, confusion, and changes in thinking, personality, memory, and orientation. The progression of deficits can lead to severe disability or death.

The drug manufacturer, Biogen Idec, notified FDA when the MS patient died after developing PML. The patient had taken Tecfidera for more than four years. Prior to developing PML, the patient had a very low number of lymphocytes, a type of white blood cell, in her blood. Reduced lymphocyte counts can weaken the immune system, which increases the risk for PML. It is unknown whether the low lymphocyte count contributed to the development of PML in this patient, or if low lymphocyte counts are a risk factor for PML development in Tecfidera-treated patients.

We urge health care professionals and patients to report side effects involving Tecfidera to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.