Here is the latest safety information document last update on 7/2011 . There are certain people on the internet who are determined to link this drug to so called "new findings" regarding the issue of PML and Gilenya. They stand by their information citing the most recent changes to the drug data sheet updated on 7/2011.
Here is that document for you to read yourself:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s002lbl.pdf
Turns out if you search that document for "PML" or "Progressive multifocal leukoencephalopathy" you will not find any results.
BECAUSE PML IS NOT AN ISSUE WITH GILENYA / FINGOLIMOD / FTY20.
This is why so many doctors are considering switching Tysabri patients to Gilenya if they have tested positive to the JC Virus or are nearing 24 months on therapy.
I hope that this will ease the minds of those of you looking for accurate, up-to-date information regarding this medication. Especially if you are considering this as a therapy of choice.
While there are other serious side effects related to the use of this drug, so far PML is NOT one of them.
My story of being a hypochondriac, an MS patient, and a guinea pig. NOTE: After 16 years on Fingolimod, I'm starting my self-designed study to taper off the drug while avoiding the now well-documented "rebound relapse" phenomenon. I'll be writing about my journey on SubStack and you can find it here: https://farewellfingolimod.substack.com/
Thanks for this Jeri
ReplyDelete- hmmm I felt like I accidently fanned the flames rather than kerbed them when she still went on about PML and paradoxically encouraged people to do research but cited her mysterious insider knowledge that only she is privy too as irrefutable while dismissing any of the public information to be had including that put out by the company.
Well it seems that the first PML case has been reported in regard of Gilenya, however it is not confirmed that the drug induced the PML or it's due to Tysabri on which the patient was earlier. In any case PML is a horrible side effect and progressive multifocal leukoencephalopathy treatments should be more effective.
ReplyDeleteThis 1 reported case, however, will significantly affect the success of Gilenya.