Gilenya Death a Coincinednce?

[kwarendorf]

Doesn't look like they can find a smoking gun.

http://www.foxnews.com/health/2012/05/15/fda-says-unsure-if-novartis-ms-pill-caused-deaths/

[SarahL2491]

I'll stick with my Tysabri, I will, this has been interesting!  Apparently fast moving problems with the oral drug.......

[twopack]

Let's see, I believe there are strict controls regulating the initial doses of Gilenya.  Therapy is initiated in the physical presence of health care professionals who monitor heart rate for six hours because it is usual for the drug to cause a slow or irregular heart rate.  True?

So people with known heart problems are usually excluded as candidates for Gilenya.  Right?

And still we are supposed to be surprised when cardiac complications and death occur soon after starting this drug?  Well, it's a fact.  Even people in the general population are prone to develop unexpected cardiac problems.

But now it's official.  The reason we can't know if Gilenya causes or contributes to cardiac mortality and morbidity is because the stricken individuals were known it have heart problems BEFORE they started taking it?  So why did they?

So Gilenya remains available but all the Cox-2 inhibitors (save Celebrex) and Darvocet were forced out of existence because they might cause heart disease in high doses or in the elderly.  (Aren't these things just more common in the elderly, period?)

Does this make sense to anyone?  It so, please help me here.

I guess it can be hard to find the smoking gun unless there is a willingness to allow the eye to follow the smoke all the way into the barrel.

I don't want drugs to be unavailable simply because of potential risk.  I want to be warned of legitimate dangers and then allowed to determine (with the guidance of my physician) the degree of risk I am comfortable accepting.

I'm sure this is a good drug for some PwMS.  MS has already attacked my brain stem.  My heart is already upset about that.  I'm always disinclined to be the first to trial newly marketed drugs (like within the first ten years or so).  I'm glad I'll never have to make a personal decision about this one.

Thanks for the info Kyle.  It’s always good to take a look when MS related issues make the news.

Mary

[Lulu54]

You too look so much alike it is hard to tell you apart!! LOL

Kyle and Alex, Alex and Kyle - you both are good guys with solid information and hearts of gold.  Could be twins but you are separated by oceans.....  

[kwarendorf]

Imagine the depth of my identity crisis!

[tingletingle]

Hey Kye,

At least she didn't think you were a female. lol

Gilenya just scares me after seeing one of the people in our group hospitalised after one tablet. The doctors here didn't ever link it to Gilenya either, just said it was one of those things. hmmm.

Alex

[kwarendorf]

Alex, Kyle...you pick :-)

[Lulu54]

well, that sort of answers part of the questions of Gilenya. I'll stay tuned for the PML connection.  Thanks for finding this one, Alex. That hadn't come through my email, yet.