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.
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