[Riverwild]

I just hate to post this, but here it is.

FTY729 / Fingolimod problems.

It sounds as if there were two or more people who contracted an infection, which hasn't been identified yet, and one person died. The trials have NOT been stopped, but all eyes are upon Novartis awaiting further news as to exactly what has happened.

http://news.google.com/news?q=FTY720...num=4&ct=title

I am including this google link because the top entry deals with all the updates on what has happened so far.

If I hear anything further I will post links.

This just SUCKS.

[AfterMyNap]

Thanks, Birthday Girl, it is a bummer. Let's just hope that this is all the damage they find. Dang, we really have to keep our hopes in check, don't we?

[Kitty]

Wow. I was going to apply to be in the clinical trials for this one but my Neuro talked me out of it. He said that there were too many questions about it for him to feel comfortable knowing I was taking it. It was ultimately my decision - but now I'm glad I opted to stay with Betaseron.

[tovaxin_lab_rat]

Thanks RW, I was going to post that. I got the alert and just haven't been up to posting anything.

It will be interesting to see what the final outcome is on this one.

[mom23angels]

Thank you for posting this. I did the online screener but haven't heard back from anyone.. Now, well I don't know if I want to do it. Right now I am not on any DMDs or anything and I actually feel better than I did before I took the Betaseron for a couple months. We'll see how this all pans out, maybe I'll change my mind if there is new info. about what exactly happened. Thanks for this article!

Monique

[starfish]

I saw this in another forum. It seems most MS DMDs do something to one part of our immune system, either suppress B or T cells, or keep something in the lymph glands, etc.

So infections are no surprise, and I don't think we should worry just yet, until we know more details about the patients and the circumstances surrounding the infections.

All DMDs have risk. It will just take time to figure out what to screen for, just like they have continued to do with Tysabri for recent liver problems and melanomas.

[ewizabeth]

My neuro spoke to me about this one... he mentioned that there were so many precautions and tests to be done... he didn't know how it would all work out. He said the drug company wanted his research team to take part but there were just so many details with all the testing, he passed.

I hope it turns out ok, this one looked so promising.

[TickledPink]

I've been in the trial nearly 10 months and while this is scary news, I'm not going to get all panicky about it. The trials (there are several) for Fingolimod represent the largest in the history of MS drugs (an estimated 1250 in my particular trial alone) and there are bound to be complications for a few patients.

We don't know what the infections were caused by or if they are even related to the use of the drug.

The benefits of having been on this drug have far, far outweighed any side effects I might have experienced.

Known side effects that I personally have had so far are:

Drop of 14 bpm in heart rate on initial dosing which was over after 6 hours.

Increase in UTIs in the first few months, no UTIs since month 4.

Increase in upper respiratory infections initially (5 head colds in first 6 mos.) none since.

Since being on the drug the benefits I have gained:

I'm made it to 1 year with no relapses; prior rate was every 3 months.

My EDSS has drastically improved.

My QoL has drastically improved.

Wonderful health care which does include many examinations. With such close observation I am optimistic that if anything were to arise it would be detected and dealt with very quickly.

While it's only natural to gasp in horror at this tidbit of news, I'm not letting it get to me. We don't have all the facts and if the independent experts who monitor the study did not feel it necessary to halt the trial then I don't feel it necessary to pull out.

After all, if I have been on it for nearly a year and gained so much, healthwise, from this experience, I'd be shooting myself in the foot to back out without having any proof that the medication was the direct cause of the death of the patient involved.

I would hate to see this thread be biased by only having people who are not participating in any of the studies for FTY720 scare off anyone who has been seriously considering entering one of them.

Until all the facts are in, I'm not forming an opinion or getting scared away.

BTW, you may wonder why I just popped in now to post this and haven't said anything in months. LOL I get Google Alerts that let me know when anything with the words "fingolimod" or "FTY720" pop up on the web. I got an alert with this thread in it and decided to come give an alternate point of view.

Hope everyone is have a great MS day! Stay well...

[Riverwild]

Hi Jeri!

Glad you stopped by and let us know how you are doing! Kudos to you for doing the trial!

This post wasn't meant as a scare, but a heads up for those who are watching this trial. A lot of people are watching because of it's large size and good reports so far.

I PRAY that it's not something that may prevent Fingolimod from helping people who need it. I also don't want to see another debacle like what happened with Tysabri, where it gets pulled and people are left hanging in the wind until they figure out what is going on!

It sounds like it's working for you just fine! Please come back and let us know how you are doing as it progresses!

[TickledPink]

Hi River,

I didn't mean to sound accusatory or anything but the more places it gets posted and people naturally react with fear or panic, the less likely those who are looking into maybe joining the trial will decide in favor of it.

I thought if I post my own facts as they relate to just my own journey through this trial that it might boost someone else's confidence so that they, too, might take a chance.

I'm a little possessive/protective of my Fingolimod because that little brown pill has literally turned my life around. When I was considering the trial I was at a very low point in my life. MS was knocking me down every 3 months and I just felt like if this was all I had to look forward to for the rest of my life, why bother? Ya know?

I was scared to death to enter the trial, scared to death not to. Fortunately for me it has given me new hope. 12 solid months with no relapse almost has me feeling human again.

Some of the things I can do now that I would not have attempted a year ago:

I can run short distances (75 feet across my yard).

I go to the store and don't worry about where the nearest parking spot is -- I have actually deliberately parked across the lot in order to get a little exercise.

I have no clue where my cane is.

I take the kids to the park and don't freak out over being in the heat. I still don't like it, but it won't land me in the hospital with a fresh relapse.

I went to the Blue Crab Festival and walked around. <-- That may not seem like much, but I have avoided all festivals in my town for the last 10 years due to succumbing to the heat at a festival and having to be carried out years ago. For me to even consider going to one was a major milestone.

I now have all the feeling back in my feet and very minimal residual symptoms from any previous relapses. Some days I feel totally normal.

All that said, I am a firm believer that it's only due to being in this study that I have my life back.

Even if the death can be somehow linked to taking Fingolimod, I doubt I would pull out unless they make me by stopping the trial. That's a chance I am willing to take for the QoL I have gained.

I am sure that even if for nothing else but the issues of the initial drop in heart rate upon first dose they will have something similar to the TOUCH program to monitor patients closely.

Sorry to have sounded defensive. I should realize that people are going to discuss this and there are going to be a lot of reactions...

Anyhow, I'm off this morning to take the kids to the movies...something else I wouldn't have been up to last year.