Gilenya scare and a reasoned approach

By now most of you know that a woman with MS in the United States passed away within 24 hours of her first dose of Gilenya. This, along with 10 other reported deaths (not within 48 hours of the first dose), prompted the European Medicines Agency (EMA) to issue a press release concerning their review of Fingolimod (Gilenya) safety.



This has been picked up by mainstream media (not just on the Internet, but also in local newspapers) and people are bringing newspaper clippings to their neurologists. It is for this reason that we felt that it was necessary to speak directly to the MS community about what we do and don't know at this time. In the video below, I interview a patient (on Gilenya for a week) who came in with the newspaper clipping that was sent to her by her concerned friend. After I addressed her concerns, we discussed our making a video to help others understand what we do and don't know. Of the other 10 deaths, 3 were heart attacks and 1 was a cardiac dysrhythmia -- so this is 4 heart related deaths out of ~30,000 people treated with Gilenya worldwide (as opposed to what the news media implies, some of these deaths were in the U.S., as well).

So, bottom line, what do you do now?

Talk to your neurologist because there may be no cause for concern and the FDA and the EMA are looking into this to see if there are new risks associated with Gilenya.




- Dr. Daniel Kantor, MD
Medical Director
Neurologique

info@neurologique.org
www.neurologique.org

MS Town Hall Meeting in Valdosta, GA on 01/21/2012

In this MS Town Hall Meeting, interactive topics include:

1. Disease modification -- newest research, currently approved medications and complementary and alternative medications (CAM). Emerging therapies:BG12, Lemtrada, Teriflunomide, Ocrelizumab, Daclizumab, Pegylated Interferon Beta-1a....

Factors include: Efficacy vs. Safety vs. Tolerability vs. Convenience (Route of administration vs. frequency).

2. Symptom control -- how to talk to your doctors and prioritize your issues. The use of NeuroFunctional Enhancers (NFEs). This does NOT necessarily mean medications.

3. Rescue treatments -- IV Solumedrol (Methylprednisolone), IM/SC ACTH, IVIG/IGIV, plasmapheresis). Only 2 FDA approved treatments (SOLUMEDROL and H.P. ACTHAR GEL).

Also, side effects of medications and how to deal with them. What to do when your insurance denies your needed medication.







Here are the flip chart notes:







- Dr. Daniel Kantor, MD
Medical Director
Neurologique

info@neurologique.org
www.neurologique.org