Just wanted to give you all a heads up, in the interest of us all being informed patients... :)
I saw this article this morning, and here's the crux of it:
"New Case of PML Confirmed in U.S.
A new case of PML, or progressive multifocal leukoencephalopathy, has been confirmed in the U.S., in a patient receiving Tysabri for the treatment of MS.
After 14 treatments, the patient reported a change in health status, and the patient’s physician began testing for PML. According to a statement issued by Biogen Idec, the drug’s manufacturer, “clinical vigilance led to early identification of signs and symptoms of possible PML and clinical evaluation which included MRI scanning and CSF testing.” The patient, who was admitted to the hospital on October 24, underwent plasmapheresis to remove Tysabri from their system and was released from the hospital on October 28. The patient is currently under the care of the treating physician."
No update yet on how she is doing. I had heard about a case of possible PML here in the US, last week, so I am assuming it is the same woman. Her husband posted about it on a site I found with people on Tysabri. I will check back there today to see if he has posted anything new -I really wasn't on the computer this weekend at all.
So, this blows apart the theory that the other two cases in Europe earlier this year were because Europe doesn't monitor as closely as we do. I think if we are on Tysabri, we just have to accept that this is a very real risk, and just be even more vigilant watching for any changes in our physical or mental status. The sooner it is identified, the better your chances are to not have so much permanent damage. I truly feel that as more and more people start to take Tysabri, there will be more and more cases of PML, as well as other serious complications and side effects. It just stands to reason...
There's still also the risks for serious liver damage, as well as the FDA now having Tysabri on it's watch list because of melanoma. There have been at least 2 cases of that this year, both after only being on Tysabri a very short time. I read about another probable case last month - they were just waiting for the biopsy to confirm it. I am watching my moles and freckles closely... ;) There have also been numerous cases of people having serious herpes infections, such as herpes encephalitis and herpes meningitis - presumably from a latent herpes virus, from chicken pox or cold sores or shingles - being reactivated as the immune system is lowered. That is part of why all bets are off once you go on Tysabri, as far as I"m concerned.....none of us knows what viruses are latent in our bodies, that normally give us no trouble, because our immune systems keep them in check. Once you start to tinker with that, you open the door to who knows what.
None of this has changed my decision to be on Tysabri...I go for infusion #2 today, in fact. I am hoping that this month I won't have to deal with a UTI or with the terrible hip pain. From talking to others on Tysabri, the UTI's are VERY common - everyone I have talked to has had a problem with them to one degree or another. Several have also had joint pain - one other woman also in her hip, which also was hideous pain for a while, just like me. I just try to be aware of all these things, but not obsess over them, you know? This month showed me that Tysabri was already starting to make a difference for me, so to me, the risks are worth it. There's really nothing else out there for me right now anyway... :)
I talked to several people here on the forum as well as one of our community leaders, before I posted this info. I don't want to alarm anyone or to seem like a doom monger, lol.....I just feel that it is important that we all know as much as possible about ANY of our potential treatments, both good and bad. We all need to be our own advocates, and we need to be as knowledgable as possible, to make informed choices about our treatments and medications.
It's been a long time since you and I have "talked." Good to "see" you, dearheart.
Thank you so much for sharing this information. I think it's very important for patients on this drug to share information with everyone. I have heard so many great things about Tysabri, as well as some of the side-effects. For so many people, the good outweighs the bad.
I guess all of us that are on DMD's do worry what they are doing to our bodies. I know that the one you take, is much more powerful than the ones that alot of us are on. I don't know what my decision would be, if I was told that Tysabri is the one that I should be on. It takes alot of thought to make that decision for oneself. You are brave.
I am glad that you are already seeing some benefits from Tysabri. That is fantastic news. Just keep a close watch on your body, as you say.
Again thank you for sharing this invaluable information. We all need to be informed patients.
I've missed you, Rita. I am glad to hear that you are seeing some improvements in your health.
This is important information for everyone here - whether they are on Tysabri or not. There is always the chance our current dmd's will fail us and we will be faced with the choice you had to make. Your positive attitude is an inspiration for all of us.
I've missed you too! I hope things are going OK with you... :) You're right, it did require alot of thought and research and soul searching to make the decision to go with Tysabri. But I'm certainly not brave.....there are alot of people here who I think are brave, and I don't even come close... :) All I did was decide to try the only thing that's really out there for me right now, instead of doing the "wait and see thing", lol. And who knows - it may only mean I was stupid in the long run! With only 2 years back on the market now, Tysabri is still an experimental drug, as far as I'm concerned. Nobody knows what the long term effects will be, or even if there are effects down the road once you go off it. The sad fact is just that there are not alot of options for those of us who fail the first line DMDs....If I'm able to help anyone here by sharing my experience, then that makes me happy... :)
As you well know, my attitude isn't always positive, lol. I certainly have my days where I'm down and it's hard - I just keep getting up cause I'm too stupid and mean and stubborn to do anything else, lol.
Got a call this morning, and the neuro isn't going to be there this afternoon, so I now have the infusion on for tomorrow afternoon. Sigh...it's frustrating, when you are mentally psyched, you know? But I'm fine now.... just another bump in the road... :)
I DO think you're brave. A lot of people would have backed off from this or never considered it, given all the history.
But you have done a great analysis of the pros and cons, and you've decided you have more chance of being helped than hurt by Tysabri. I think you're right. Especially given that you are being monitored very carefully for all the risks, and can get the drug out of your system if the need arises.
We all need to take care about catching a virus, even if we're not on a DMD. We're not more likely than the general population to get sick, but if we do catch something, that can trigger an MS flare. That goes for any of us on one of the CRAB drugs and any of us not on anything. Rita's case is different. A drug that suppresses the immune response is kind of scary.
I do hope it works for Rita. As far as I know she's our only member currently on Tysabri (if I'm wrong please speak up). So let's send her our support and encouragement.
Rita, please do keep us informed about your infusions and any effects you're experiencing. We'll be here cheering you on, whatever your treatment decisions.
That is an amazingly eloquent discussion of the state of Tysabri from the view of one woman. I felt honored to read it and peek into your psyche as you told us about your (yes, brave) decision. I realize that "brave" must be measured against your choices without Tysabri, but you didn't shrink from the analysis and the decision.
We are all rooting for you and glad you are one of us!
Thanks for your kind words and support, but I know I'm not the only one here on Tysabri....lbradley35 has been on it longer than me, and with an improved MRI for the first time ever! (Go Lori!!). I know there are maybe another 3 or 4 others here too, I'm not sure. And we have several people here involved in clinical trials, which is also a major leap of faith... :)
Believe it or not, my big fear at this point is that if more problems keep cropping up, the FDA will pull Tysabri off the market - and then what will those of us in my position do? If Tysabri is taken off the table, the only thing left is Novantrone or clinical trials. And if I fail Tysabri, I don't know if I would qualify for very many clinical trials anyway.
So it's not bravery at all - it's more of a lack of options and blind optimism, I guess, lol. Plus, I am VERY fortunate in that I love and respect my neuro, and he respects me and my knowledge base and desire to research - I always have the final say in treatment options, but I also know that he truly wants to help me and is trying to avoid (or at least delay) what he can see down the road for me.
He is very intelligent, and pretty up on current issues with MS - when he talks, I pay attention, and then go home and do my research and come back with questions for him. It's a pretty healthy partnership....because at some point, you have to close your eyes and trust this person to a certain degree....to feel comfortable that the person taking care of you will always be looking at you as a person, and they will always be trying to do what will be best for you in the long run....
I have heard so many stories here about people being treated so poorly by their neuros, or people who have flat out had bad medical care - it makes me sad and angry. I told my neuro he's like a unicorn or Bigfoot - you hear the stories about good neuros, but they are so hard to come by, lol. Bless his heart, it made him smile and blush... :)
I found it interesting that in making the decision to allow Tysabri back on the market, the FDA acknowledged that people with MS should be allowed the decision to take the risks involved. It wasn't that suddenly Tysabri was found to be safer, but that its availability was needed by people with a nasty disease and few options.
I will say that the news about melanoma was news to me.
My problem with Novantrone is that it does damage to the heart from the getgo. You are monitored (ideally) very closely (with even closer monitoring being recommended). But, the damage is cumulative until they see a point beyond which the heart is damaged too much. Many people think they are okay until the 2 year mark at which the heart affects just suddenly appear - not so. This scares me much more than anything I've heard so far about Tysabri.
But, I see why they discourage people from leaping onto Tysabri until the alternatives have been exhausted.
Thank you for the wonderful compliment, and for your encouragement... :) (But be careful - peeking into my psyche can be very scary, lol.)
I am just an information geek who reads alot, lol. And I'm a realist who always wants to see as much of the picture as possible. It is a very complex topic, as is MS in general .....and such an individual choice. My family and close friends have also been educated about the pros and cons of Tysabri - even if they really don't necessarily want to hear about the bad stuff. But it's all part of the reality of this medicationi, and I don't want anyone to be possibly blind sided later on, you know?
I try to keep informed as best I can. The FDA warning about liver damage (to possibly include the need for transplantation) came in February of this year, I believe. The announcement that Tysabri was on their "watch list" of 20 meds - for melanoma - came within the last month or 2. And you are right - a big part of the FDA letting Tysabri back on the market in the first place was that Tysabri patients lobbied hard to have it back. Plus, at that time, the thinking was that PML was linked to Tysabri being used in conjunction with other MS treatments, especially interferon. And for 2 years, that seemed to be the case, and everyone was just starting to breathe a sigh of relief... :)
Novantrone scares me more, too. The cardiac toxicity is a major thing, and my neuro doesnt like to use it for that reason. But there are people who have used it and said it helped. The new studies released on Campath seem very promising, but it has not been without it's risks, either. (I saw a plaque that cracked me up - it said, "If we knew what we were doing, they wouldn't call it research", lol!) But in all fairness, it's kind of hard to come up with effective treatments when they don't know exactly what causes MS...and they are still trying to understand the mechanism of the damage that is done. Years ago they didn't even realize gray matter damage played into it much at all.
So much yet to learn....so much promise on the horizon. Who knows where we will be in 20 years? What a great day it will be when they either find a cure, or a treatment that is lower risk! Till then, all you can do is work with what you have at your disposal... :)
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