A Bitter Pill To Swallow: Gilenya (Fingolimod) death toll up to 11, FDA reviews drug.

For those of us with Multiple Sclerosis, Novartis’s fingolimod has been the first real pharmacologically approved option for a disease modifying drug that would allow us to stop either taking injections (with Copaxone, Rebif, Betaseron, or Avonex) or having a monthly infusion with Tysabri.

Now, I don’t know about you, but most folks don’t love needles. Gilenya was the hope of generations of MS patients to be able to simply take a pill for our condition. That’s why, when a patient died within the first 24 hours of their first dose of Gileyna, Novartis was reasonably concerned.

Both the European Union and the FDA are reviewing Gileyna (also known as Fingolimod). This doesn’t mean that it is going to be pulled from the market, or that the drug itself is bad! It just means they want to review it to ensure the safety of Europeans and Americans who have multiple sclerosis and who choose to take that medication.

This doesn’t mean the end for Gileyna. There were a number of deaths from PML that occurred before Tysabri was pulled from the market in 2005 and then reintroduced in 2006 with new safety precautions and a “risk-benefit” analysis.

Now, I don’t know about the “risk-benefit” analysis for any of my fellow MS sufferers. I can only speak for myself… but when death is on the line with your disease modifying drug, I personally believe that you’re messing with something far worse than your incredibly annoying and often painful disease.

To put it frankly: Multiple sclerosis itself is not fatal, so why would you take a drug that has proven itself fatal to others and very well might cause fatality in you?

I may not love giving myself a shot every night, but I can guarantee you that I will continue doing it until they create a pill or liquid that doesn’t kill folks — or until my symptoms disappear (and stay gone) thanks to the Paleo Diet.

That being said, I have plenty of friends online who would swear by their wonder-drug, and who are doing very well on Gileyna and are hopeful that the FDA simply says, “keep in good contact with your doctor.”

Whatever the outcome, my heart goes out to the families who have lost loved ones, and my hope is that the safety and care of those patients still living and on the drug are put ahead of Novartis’s profits, while real research is done.

Good health, everybody!

2 thoughts on “A Bitter Pill To Swallow: Gilenya (Fingolimod) death toll up to 11, FDA reviews drug.

  1. That is so sad and such a tragedy. I think they should pull it from the market, but I am sure they have a certain process and analysis to do before it warrants that. This is just my knee jerk opinion.

    Thanks for the information.

    • I would have switched to Gilenya, if not for some of the side effects that I was reading about. I really hope they are able to improve the med.

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