Gilenya - Patient dies after first dose

[Lulu54]

I didn't know what else to put in this title other than what I know - you can read about the details at a couple different sources:

http://www.businessweek.com/news/2011-12-13/novartis-confirms-patient-died-after-starting-gilenya.html

http://www.cnbc.com/id/45641791/Novartis_investigates_death_of_Gilenya_patient


I don't know what the number of patient taking Gilenya is to put together a number for this new statistic, but that doesn't matter to this one patient if it is implicated in his death.    

I am sharing this news not to be an alarmist, but to make sure everyone knows of this questionable risk.

be smart,
Lulu

[Sarahsmom46]

Thanks for balancing out this discussion.  Any drug has the potential for causing harm no matter what it is.  We all have to educate ourselves and of course follow the guidance of our medical professionals when making decisions on changing medications or starting a newly approved drug.  Consumer beware but also be informed.

[HVAC]

It is all risk/ benefit ratio with any drug. You have to decide whether you want to go on any drug or have any procedure.

Heck I just found out recently one Tylenol is all it takes to kill me. I never had an issue in the past but I do now.

Look at all the ads for lawsuits on TV for drugs. I have been on many of those drugs and in some cases I still am and am going to stay on them.

The biomarkers will be great but from what I hear they are a ways off  to every day use is that right?

Alex

[shoshin]

I don't mean to put anybody off Gilenya. I was in an FTY720 trial for a year and half and on the real drug (low WBC). Just go in with your eyes open.

There seems to be a fair amount of disagreement even among neuros on the risk profile. My regular neuro was very gung-ho and kept talking about how safe Gilenya is. The neuro in charge of the trial was the opposite and kept reminding me of the potential dangers.

There are definitely the known knowns (macular edema), the known unknowns (FTY720 did something funny to mouse lungs; they don't know if it means anything or exactly what happens to human lungs) and we don't yet know about the unknown unknowns.

Not taking Gilenya isn't necessarily a safe choice, either. Are you sure you're going to end up with real benign MS? Will you be sorry for not getting out the big guns early on?

I haven't suffered any bad effects yet, but Gilenya did me no discernible good, either. So that's another risk factor. What if you're in the group that doesn't benefit from a given drug?

There seems to be a school of thought among some neuros that only some percentage of people taking a given DMD are responders for whom the DMD is working. So the clinical trials show an average effect--the combination of a much better effect for the responders and no effect for the non-responders.

In fact, they've found a potential biomarker that could identify people who respond to beta interferon: http://med.stanford.edu/ism/2010/march/sclerosis.html

sho

[Lulu54]

In discussions with my msologist earlier this month about other treatment choices he specifically said he wouldn't offer me Gilenya because of my cardiac history.  

[opie74]

I am on it.  My Dr. spoke to me about this at my appointment this week.  It is known that Gilenya can mess with your heart rate especally after the first dose.  It may also cause some blood pressure issues as well.  I happen to fit the bill.  I have Naturally LOW blood preassure, a naturally HIGH resting heart rhythm, and verry little family history of heart disease.  I am also only 37.

The decision is not one to be made quickly.  I know several young mothers (well, if you consider me young) that are on it.  The flu-like symptoms of the others made chasing toddlers a mess.  I also have 30ish leasions, and I had 3 relapses in the pryor year on Betaseron.  Like I said, I am a prime candidate.  It definately is not for everyone.  Thank you LULU for sharing this.

Ann

[meg321]

My Dr. wouldn't give it to me until it was proven to be safe....I don't think I want it now at all.  

meg

[tingletingle]

The other male in my MS support group took one tablet a few months ago and ended up in hospital. They still have no idea what caused the episode. The neuro took him straight off Gilenya and is now back on Tsyabri.Unfortunately, the gent is in his 70s and broke his hip in the second week.

There is one lady in our MS support group who takes Gilenya and swears by the positive effects it is having on her. Infact she is practically jumping out of her skin and doesn't need her cane anywhere near as much.

So, the reactions seems very individual.

Blessings
Alex

[maxthecat9196]

Wow!  I had no idea it was so serious. Although I am having neurologist trouble right now, it does make me wonder if maybe I dodged a bullet by being refused gilenya...

Tammy

[anon07072023]

Yeah, this one is definitely OUTSIDE my comfort zone.  It was before, and this pretty much seals the deal for me.  
Thanks for sharing this Lu.

-Kelly

[shoshin]

There was also a case where a patient with NMO/Devic's got worse on FTY720:

http://www.ncbi.nlm.nih.gov/pubmed/22146605

I think this is why a lot of neuros are reluctant to use Gilenya as a first-line DMD--yes, it seems to be more effective, but it's also more dangerous and we won't know all the dangers until it's been in wider use for a longer period of time (like PML and Tysabri)

I wonder also if Gilenya would ever be approved for CIS since the potential cost of a mistake is much higher.

Like Lulu says, be smart. We all have to find our comfort zone with the risk/potential benefit trade-off.

sho