tysabri pml two new cases

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 am referring to the total deaths that have occurred among the confirmed cases of PML in patients who have used Tysabri since it became available for prescription in July 2006. The National Multiple Sclerosis Society website has an Update on Tysabri and PML as of August 15, 2012. This gives the total number of confirmed PML cases since July 2006, as well as how many of these patients have died. (In truth, these are actually the numbers as of July 3, 2012.

And even if Tecfidera ultimately was directly connected to PML, know that Tysabri is too, and yet the vast majority of patients use it safely every month. It's something to be aware of, but no reason to throw out the Tecfidera yet. http://www.foxbusiness.

• Although the absolute risk for PML in patients treated with Tysabri cannot be precisely determined, the U.S. FDA and the company have released data suggesting that the risk increases with increasing time on therapy. • The company changed the label of Tysabri to indicate that the risk of PML is increased in patients who have been treated with an immunosuppressant (such as mitoxantrone, and less commonly, azathioprine and methotrexate) prior to receiving Tysabri.

There are apparently two new cases of people on Tysabri with progressive multifocal leukoencephalopathy (PML). See http://www.bloomberg.com/apps/news?

Just an update on PML, for anyone who is currently considering Tysabri, or who may need to look at it in the future...the original 3 cases of PML were indeed initially considered to be due to the use of Tysabri in conjunction with other treatments for MS, particularly interferon.

Plasmorephis, blood filtering is already standard treatment to get Tysabri out of the body quickly if PML happens. I saw that a trial had been registered with the US FDA in clinicaltrials.gov when Tysabri was returned to market a trial was registered for Plasmorephis blood filtering to remove Trysabri from the body quickly whren it needed to be removed quickly. I was proud of myself for noticing when that trial was registed with the gov & watched it's successful completion.

I expect that over the next year or two, as more and more results come in and can then be compared to documented PML cases, we will learn more ... so at this point, we just continue to make treatment decisions on all the other factors we have used to evaluate the situation up to now. I hope things are going OK with your sister and the Tysabri. And hopefully you won't have to consider that choice any time soon.

My neuro is a Tysabri researcher and he has been working with a lab here studying a new blood test for the presence of the JC virus and what the new results mean for the risk of getting PML. The test that up to recently has reported that the virus IS in the body or NOT in the body. There is a new assay that can report it's actual titer. The research from multiple centers is showing that some people with the virus and a negative earlier test actually DO have the virus.

Another concern is that almost all (if not all) of the cases occur after a year or two. Tysabri has just been returned to the market now for only two years. The risk pool is still growing and "coming of age." They are developing new ways to pick out who is most at risk for the infection and stopping Tysabri early with some people.

Here is a site run by a German man - it always has the most up to date stats on the PML cases. It lists how many cases, what country the person is from, and how many doses of Tysabri they have had whenever he is able to get the information. I check the site frequently - he always has updates as soon as they are available. http://chefarztfrau.de/?page_id=716 This article gives the latest calculations of the risk factor for PML, based on how long the person has taken Tysabri.

My clinical exam was good and my brain MRI was free from evidence of PML and free from any new lesion activity. I have been having some issues with my left leg lately, beyond my 45 minute exercise wall. My left leg can sometimes have a mind of its own. If I walk down a hallway and turn right it wants to keep going straight, He seems to think that there may be some activity in my c/t-spine. He also thinks I will benefit from some PT.

Last week when she went to the doctor, she was informed that patients who has been on the tysabri infustion for over two years have a greater chance of developing the brain infection PML. I believe she was told the odds went up to 1 in 800. However, she was also told that if she were to stop tysabri she was pretty much guaranteed to have an attack of the MS. She has an agressive form of MS and other medications don't seem to work.

As of March 2008, more than 26,000 patients were on Tysabri® worldwide. Since the re-launch of Tysabri in July 2006, no new cases of progressive multifocal leukoencephalopathy (PML) have been reported. PML is an often-fatal viral infection of the brain. Data from the PLEX study suggest that plasma exchange may be an effective procedure for accelerating the removal of Tysabri from the blood if PML infection is suspected.

They recently have been accused of under reporting the number of PML cases in Europe - if this was done intentionally, that would border on criminal. Now even though the above are strikes against biogen in my opinion... if it were me, I think I would still take the tysabri if faced with these types of options. I am older, my kids are grown, and I don't have near the responsbilities I had when I was younger. Its a risk I would take to keep the MS from progressing.

Several key points which I think are close to the truth - people who do MS clinical trials fall mainly into two categories - either young and new to dx and have little to lose or advanced disease that isn't responding to tx an again has little to lose by participatin in a clinical trial. Both groups seem to do well in trials . Perhaps This self-selection for participating in trials skews the results.

t changed his feelings about Tysabri, and he said that he feels there will be more cases popping up as we go along. His thoughts are pretty much like mine - as you get more and more people on Tysabri, we will see more and more PML cases, as well as other serious infections and side effects.

Novartis (the maker of Gilenya) at this point is attributing the PML to the prior Tysabri usage, but they acknowlege "that the contribution of Gilenya to this case can not be excluded." I figured I'd post this just as a heads up ... not trying to freak anyone out, just something to be aware of and keep an eye on. It will be interesting to see if this will be an isolated incident, or if there will be more cases to follow.

There have been at least 5 cases of PML in patients treated for psoriasis with Tecfidera (different brand name, same generic drug though). Now there has been a case of PML in the US in an MS patient being treated with Tecfidera. My doctor talks to me like I'm an idiot because I'm just not real excited about doing one of the drugs even though I'm JCV +. She said my disease is very active, which I'm well aware of -- I'm living in this body, not her.

Funny you mention Tysabri the MS Specialist mentioned that he was alarmed the cases of PML had increased since he did his last power point a few months ago from 14 to 23. He kinda hinted it will probably be pulled from the market. Originally they were blaming the PML on avonex and tysabri used in combination. He says he only uses it when nothing else can be used.

Tysabri pml two new cases

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