NEURO SAID STOP GILENYA

[isamadjul]

Thought about posting under Meds but thought more ppl would see it here.

Just got a call from my Neuro Dr. Sullivan in Grand Rapids MI and he said he is taking his patients off Gilenya. Not sure if its just newer patients or all but I've been on it for about 2 months.

He still wants eye exam and blood work in about 3wks. Dr. Sullivan is waiting while the investigations are going on.

Thought you guys might want to know what my doc had to say about it.

isamadjul
(allyson)

[Waydwnsouth1]

I read where the European Medicines Agency is re-investigating Gilenya and the side effects. The report stated there have been 6 deaths of patients that were all taking Gilenya. They have not determined if Gilenya is the cause but it seems to be an odd coincidence. I would imagine if Europe has opened a new investigation the FDA will too, if they have not already.

That may have something to do with your neuro pulling his patients off the drug.

[sexygatubela]

Here's the link for information on European Medicines Agency review of Gilenya: http://www.ema.europa.eu/docs/en_GB/...C500120704.pdf

[Kraheera]

My neuro flat out said that he doesn't even offer Gilenya as an option for new MS patients unless his "first tier" drugs seem to not be effective/helping. Same with Tysabri, because he feels that the risks are too high without trying other things first.

I love my neuro.

[isamadjul]

Did other DMD first

I started with Beta but while on it for about 8months I ended up with some reactions that lead my new Neuro to say that beta was not for me. He further stated that with my age and DX he doesn't feel the other crab's will do much good. I tested positive for the JCV so Ty is out and I really didn't want to do G anyways. I felt it was to new of a drug and "untested" in the "real world". Kinda like when Ty first came out. The more ppl you have taking a drug the more you find out about it.

This could all end up being a scare BUT its good to know that a lesson was learned after Ty...

isamadjul
(allyson)

[MarkLavelle]

He further stated that with my age and DX he doesn't feel the other crab's will do much good.

You should ask why he says that. I've never heard anything about age vs. effectiveness of the CRAB DMDs.

My neuro doesn't want me on the interferon drugs because my immune system has already been 'compromised' (chemo & radiation), but didn't hesitate to recommentd Copaxone. Age was never mentioned (I'm 55)...

[isamadjul]

moving on up

I believe its because I'm younger (just turned 33) and he said at our last meet and great that he feels I'm already SPMS and that at this time I got the understanding that he doesn't feel like there are any other DMDs that might help me. I could of misunderstood him....I see him again in March for my final follow up on Gilenya...

So i guess I didn't say it right. Its not age vs DMD...its me, Neuro and DMD? IDK how to say it.

isamadjul
(allyson)

[0485c10]

ismadjul-- tysabri is just starting the Ascend trial for the effectiveness of using tysabri for SPMS---it just started phase 3b. the fda just published the risk of PML for jcv+ an jcv-. its less than 1 in 1,000 for 24 months on ty.

you might want to look at that as a temporary treatment? as it is a trial, normally the costs of treatment are covered for the patient.
it's still recruiting. the trial is for 96 weeks(1.8 years)

http://clinicaltrials.gov/ct2/show/N...tysabri&rank=2

on another note, i have been wanting to post this some where...i am so proud of the US FDA for how quick they jumped on this Gilenya unexpected fatality issue. the way i followed it, the us fda had a fatality, they notified the EU medicine agency who replied with, oh yeah we had 10, we had better look into this.(duh???)

the US FDA started investigating, quickly determined that 65 y.o. patient, who had not had pre heart strenghth tests, who was on a heart medication and still the EU medicine agency is looking into the 10 fatalities they happened to have on their books, not sure where they occured?

i am so proud of the us fda response in an economic time of declining budgets. it makes me feel good to be an american in a time where there are many reason not to feel so good about my country.(a ying/yang thing)

[Arthur Spooner]

I have to agree with you 0485. The EU have never been effective in making fast decisions.

Let's face it, the EU consists of so many countries, with so many differing political systems, and so many languages, it always amazes me that they manage to achieve anything. Glad I also live in a country that is able to act and react independently and swiftly.

[markandel]

Stopped taking All CRAB's

The last attempt- Gilenya-horrible. Within only 3 weeks found out thru my opthamologist Macular Edema! Fatigue, horrile back and neck pain and made my walking compromised. I will not experiment anymore w/interferons of any kind. I am going to FVEC plan for my MS. Fish Oil, Vitamins, Excercise and Chiropractic.

[0485c10]

I just posted in the Gilenya section, that the US has had the preponderance of deaths of people who have used Gilenya...

its early yet,so i'm sure that its like Waydwaynsouth wrote, they have not determined the cause but it seems to be an odd coincidence.

so actually it looks like the US FDA was late in their investigation.

one thing i noticed as i processed this database. tysabri has deaths too(45 since 2008) but those deaths take longer, people have LT "life threating" situation first, often lasting over multiple quarters. with Gilenya its much quicker,can occur and be reported within a single quater.

If gileya was the cause?(i think that has to be determined), but it seems to be an odd coincidence.

I think that's why US doc's are responding so strongly, like taking all of their patients off Gilenya.

link to post in gilenya section..

http://www.msworld.org/forum/showthread.php?t=117839

[Lexie]

I have been on copaxone for 8 months now. My original neuro resigned so I had to find a new one. Like him better but he made a comment at Christmas that I had a very mild case (Yes I was having a good day when I saw him) and he wanted to do another brain scan in April and possibly take me off copaxone. Well, I have mixed feelings about that. As much as I hate the injections every day I feel at least the copaxone is trying to slow the progression of the disease. I am 61 years old but I'm not giving up because I am old. That comment has bugged me since I saw him in December? Any suggestions?

[0485c10]

. tysabri has deaths too(45 since 2008)

Correction:
actually i'm wrong..last "official report" in Dec 2011 was 39. 45 people who got tysabri induced PML in Dec 2011, and serum samples were available any where from 6-187 months before PML... all 45, tested positive for jcv antibodies. no one got pml without testing positive for jcv antibodies..

Except for one person who had plasmaphoresis done before a serum sample was drawn. likely the plasmaphorisis lowered the jcv antibody concentration below the level the test could detect.

i got where all these #'s belonged confused; 39 is deaths since 2008 & 45 is PML & jcv+ by dec 2011(official/confirmed).
total of 193 instances of PML (official dec 2011) and 203 PML current to date(unofficial,Jan 2012).

[KyleW]

My doc, and all the neuros in his practice, are taking everyone off Gilenya until more info is available.

[MarkLavelle]

I have been on copaxone for 8 months now. My original neuro resigned so I had to find a new one. Like him better but he made a comment at Christmas that I had a very mild case (Yes I was having a good day when I saw him) and he wanted to do another brain scan in April and possibly take me off copaxone. Well, I have mixed feelings about that. As much as I hate the injections every day I feel at least the copaxone is trying to slow the progression of the disease. I am 61 years old but I'm not giving up because I am old. That comment has bugged me since I saw him in December? Any suggestions?

To me he sounds totally irrational! But if he still thinks that in April I'd ask him why, and point out that Copaxone may be the reason your MS is mild (so far). And by the way: Nothing in your MRI(s) can tell him you shouldn't be on a DMD!

And if he still wants you off Copaxone, I'd find a new neurologist ASAP!