Tecfidera patient dies from PML

[essdipity]

According to the Boston Globe, a patient who had taken Tecfidera for several years (in trials first, then prescribed) has died of PML, the brain infection caused by the JC virus. Apparently the patient had been deficient in white blood cells over a protracted period, and this may have allowed her immune system to mount a poor response to the common virus, which although present in about 50% of people, produces no symptoms under normal circumstances. Till now, Tysabri has been the MS drug causing PML concerns

Here is the Globe article
http://www.bostonglobe.com/business/2014/10/22/biogen-idec-reports-death-patient-that-had-taken-its-multiple-sclerosis-pill-tecfidera/xrAtOBsxA7eHZN3BB0phxJ/story.html

In his most recent blog post, the Wheelchair Kamikaze (http://www.wheelchairkamikaze.com/) discusses this topic in detail. He points out that the patient's doctors, in an incredible move, knew the patient's white cell count was low and had been low for years, yet didn't stop the drug.

I take Tec myself, and my neuro will be testing me every 3 months for level of lymphocytes, the blood cells that fight infection. I'm sure he'd let me know if this falls significantly, but I'll ask each time anyway. I'll go off the drug right away if the threshold falls more than minimally. And of course I'll now have myself tested for JC.

We on this drug, and there are lots of members here who are, need to be very vigilant and keep up with developments on this front.

ess

[kwarendorf]

mind giggling should read mind boggling. I hate autocorrect :-)

[essdipity]

I totally agree, Kyle. It doesn't even matter if the patient, for some inexplicable reason, wanted to stay on Tec. The doctors should have refused, period.

This patient's family has grounds for a lawsuit. Small comfort, though.

ess

[kwarendorf]

" the patient's doctors, in an incredible move, knew the patient's white cell count was low and had been low for years, yet didn't stop the drug."

This is mid giggling! We all know that there are risks associated with all DMD's. We also rely on our doctors to manage the risks. Doctors that ignore evidence of danger should be stripped of their licenses.

Kyle

[Lulu54]

This is not the first PML associated with dimethyl fumarate - the drug that is used for Tecfidera.  It has been used in Europe for psoriasis and there were cases of PML associated with that as well.

http://www.medscape.com/viewarticle/803100

Dimethyl fumarate used to be commonly used as a fungicide in furniture but was banned because it was making people ill.

Remember this is like every one of all these potent drugs - there are pros and cons and its often hard to figure out the true story. I wouldn't panic but definitely have your doctor doing the right tests and doing them often.

Laura

[Lor301]

This is frightening. I'm going to speak to my neurologist about it. Thanks for sharing

[immisceo]

Thanks for sharing the information Eric. There's always a little bit more to these things. I'm on a study with Biogen and a few years into it, a man died of liver failure. It turned out to be related to a pre-existing (nonMS) condition, but they immediately rolled out monthly liver function tests as part of our protocol and we were immediately informed as to the whys and wherefores.

As you said, you have to determine you're own level of comfort with certain unknowns/unknowables. It's the flipside of new/cutting edge medication.

[EJNILB]

Hi, All:

I started Tec in June 2013. After learning of this news last week, I called my specialist and spoke to his nurse. I am seen at a large teaching hospital in Boston which is very close to Biogen's HQ. She told me the drug company's reps were in several times after the news broke. I assume doing damage control.

Here is what she told me about the patient that died. It was a female who had lymphopenia for 3 years, with chronic levels between 250 and 400. She came down with pneumonia and PML set in subsequent to that. The biggest question is whether the physician following the patient was negligent or if the patient fully understood the risks and chose to stay on the treatment.

Before I started Tec I was checked for the JCV (negative) as well as baseline levels of WBC, absolute lymphocytes and liver function. After 6 months on treatment I was checked again. My absolute lymphocytes dropped from a baseline of 2200 to 1000. This is consistent with what was seen in the clinical trials, i.e., a linear drop starting around day 90 before rebounding.

At one point I dipped to 900 and was being checked weekly. Luckily I eventually rebounded to 1800. The weekly testing stopped and now I am checked every 90 days. I currently sit around 1000. I was told, notwithstanding JVC status, there is no reason to worry unless levels dip below 600. Personally, I'm not ok with anything under 800 and will make a move if that happens. Everyone will have their own personal threshold.

Just wanted to share my experience.

Thank you,
Eric

[Corriel]

I need to have a chat with my neuro. Not sure if he will test for JC virus but all he was concerned about when I started Tec was liver enzyme testing once or twice a year.

When the Biogen nurse agreed with me that my WBCs should also be tested I asked my GP to do it.

Since the situation has come out with PML I have heard nothing from my neuro so I guess I will need to call his office to ask him about additional ongoing testing.

I still cannot understand why this patient was still on Tec despite her lab results. Kind of scary.

Thanks for sharing,
Corrie

[karryon55]

I've had the same problem a few years back where my white blood cells kept dropping to zero several times. I was on Rituximab & Methotrexate at the time but the Methotrexate injections were ceased immediately. I had been but into isolation or reverse barrier nursing & commenced tons of antibiotics as well as Neupogen injections to bring my white blood cells back up.

It was scarey because it kept happening & then I finally got septic, tachycardic as well as infection in the bone & I had no idea how close I was to deaths door at the time. My body had nothing to fight infection with so I spent a long time in a room on my own to only have someone come in dressed in a gown, booties, hat, glasses & a mask so I rarely had any visitors.

It was reported to the Riuximab people of my condition & I believe I was one of the first to have this problem with RA. I believe it is more common in cancer patients though due to their chemo. I am watched like a hawk now & can't have any treatments before checking my blood counts. I have no idea if I'm JCV pos or neg but after reading this I think I should find out.

I was in such a serious condition at the time that the bone marrow biopsy was too risky to do so I still don't know if this is DMD related or if I have another autoimmune condition that mucks with my white blood cells. Either way there are injections available that can help increase your white blood cells & to hear of a person who was known to have had problems with their WBC & to have not had the doc intervene is really sad.

It is deadly if you lose your WBC & if you have lost them then you definitely will be riddled with infections & bacteria. This is very sad to hear about this woman but it is a good wake up call to be vigilant with checking your WBC because I'm sure if they were ok in this woman she would no doubt not have been at such a high risk.

Thanks for that information ess & I need to go check what my JCV status is. I'm not even sure what virus it is called in Australia.

Karry.