Columns The MS Wire - A Column by Ed Tobias FDA Warns of Possible Dangers of Stopping Gilenya FDA Warns of Possible Dangers of Stopping Gilenya by Ed Tobias | November 27, 2018 Share this article: Share article via email Copy article link If you are being treated with Gilenya, take note. The U.S. Food and Drug Administration is warning that if you stop using Gilenya (fingolimod), there’s a chance your MS could become worse. The FDA issued a safety alert saying that this only happens rarely, but when it does, the disease could become “much worse than before the medication was started” and “result in permanent disability.” The FDA’s alert doesn’t provide details, however, about how rare these problems are. If you’re stopping Gilenya The FDA says you shouldn’t stop using Gilenya on your own. If you’re concerned about the treatment, you should speak with a health care professional. If you have already stopped using the medication, the FDA says you need to immediately contact your healthcare team if you experience a new symptom or if a current symptom worsens. Examples include weakness, trouble using your arms or legs, and changes in thinking, eyesight, or balance. If you’re a healthcare professional The FDA says healthcare professionals should: Inform patients before starting treatment about the potential risk of a severe increase in disability after stopping Gilenya. Patients should be carefully observed for evidence of an exacerbation of their MS and treated appropriately when Gilenya is stopped. Patients should be advised to seek immediate medical attention if they experience new or worsened symptoms of MS after Gilenya is stopped. Test for new or enhancing lesions by magnetic resonance imaging (MRI) if an increase in disability occurs and begin appropriate treatment as needed. Encourage patients to read the patient medication guide they receive with their Gilenya prescriptions, which explains the benefits and risks of the medicine. Background on Gilenya Gilenya was approved by the FDA as a treatment for relapsing MS in 2010. It’s a class of medication called a sphingosine 1-phosphate receptor modulator. The National MS Society website says the treatment “is thought to act by retaining certain white blood cells (lymphocytes) in the lymph nodes, thereby preventing those cells from crossing the blood-brain barrier into the central nervous system (CNS). Preventing the entry of these cells into the CNS reduces inflammatory damage to nerve cells.” Last May, the FDA approved Gilenya for use by children as young as 10. It’s the only disease-modifying therapy approved for MS patients who are that young. Approval for use by children in Europe has been recommended by a committee of the European Medicines Agency. Final thoughts I think people need to keep two things in mind. The first is that all disease-modifying treatments have the possibility of side effects, and some are more serious than others. We who use the treatments should always be doing so with our eyes wide open and fully informed of the risks. The second is that in the case of Gilenya, this new safety alert calls the problem “rare.” If I were using Gilenya I’d have a serious “where do we go from here” discussion with my neurologist and resist jumping to any conclusions on my own. You’re invited to follow my personal blog at www.themswire.com. *** Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis. Print This Page About the Author Ed Tobias People say to write what you know and Ed Tobias knows about MS. He's lived with the illness since 1980, when he was 32 years old. Ed's a retired, award-winning broadcast journalist and his column combines his four decades of MS experiences with news and comments about the latest in the MS community. In addition to writing his column, Ed is one of the patient moderators on the MS News Today Facebook, Twitter, and Instagram sites. He’s also the author of “The Multiple Sclerosis Toolbox: Hints and Tips for Living with M.S.” Ed and his wife split their time between the Washington, D.C. suburbs and Florida’s Gulf Coast, trying to follow the sun. Tags FDA, Gilenya (fingolimod), Novartis, relapsing MS Comments Lisa I find the timing of this to be interesting. There are many people with all kinds of auto immune conditions that are finding great success through diet, supplements and other forms of help that do not require the "popular" drugs so quickly suggested by doctors. Now, the FDA is scaring people in to not discontinuing using these drugs that have so many high risks. Very interesting. Reply Pamela There are risk with anything we eat or drink too! Look at all the recalls lately on our food and where I live the water is not safe! I think everyone should take in consideration all things they put into their bodies. Yes we should do what we can as far as diet, vitamins, etc. but were it not for MS and CIDP meds. I don’t know where I would be. I actually had a bad reaction to Gilenya myself. But called my Dr. immediately and we stop the Gilenya. After a couple of weeks I tried Tysabri and I had to pray a lot about this because it can cause PML and I am actually JC VIRUS positive. But I was on a walker and had to have help with everything. Now I am off my walker and doing most things myself, a little slower than I use to be but I can function without assistance and I praise God first of all and I thank God for a Dr. that cares and listens to his patients. That being said we have to be our own patient advocate and we have to being willing to learn and listen to the good and the bad and make our own decisions based on what we feel like is the best plan of action for our lives and the ones who love and take care of us! They certainly don’t get enough acknowledgement. Sincerely Pamela Reply Kim I am curious as to which auto immune disease you have and are you on any form of medication for it or do you have success with holistic medicine and healthy diet? Reply Jason I found I had MS in November of last year. I found several sites, outside of the US, that do HSCT. I chose one and haven't looked back. Do yourself a favor, if your early into it like me, do HSCT. Forget about what you read on US sites. Reply Anne There are sites in the US that also do HSCT. Chicago's Dr. Burt being one of them. Look into it! Reply Tom Isn't this just rebound disease like you get with alemtuzumab, where the sequestered reactive immune cells are unleashed upon drug withdrawal? Not very unexpected. Are there not accepted protocols for this problem already? Reply Gilbert Bryant My name is Gilbert Bryant. I was test patient number 10 for gilenya starting in 2007. I was very blessed. To be in the study to see how long it took gilenya to leave the human body. It took 6 weeks for the medication to start to leave the human body. Bye week 7 and week 8 the medication was 100% out of my body. The MS was back. Put me back on the medication it took two weeks to get back into to my bloodstream. The numbness and tingling was gone. Thank you gilenya for giving my life back. Gilbert Bryant. Test patient 551-010. And test patient 0 0 0 0 1 for gilenya is open study Reply Ed Tobias Hi Gilbert, Thanks very much for sharing that information. It's very useful. I wish you the best of luck with your continued treatment. Ed Reply Christine This happened to me in April after stopping Gilenya in early March. The relapse required a trip to the local community hospital by ambulance and was misdiagnosed as severe labyrinthitis. I had vertigo, dizziness, nausea, vomiting and double vision. The resident neuro did an MRI, and didn’t see any sign of new MS activity. After 8 weeks of in home PT, my vision has improved and some balance returned, but I have lost a lot. Then while still waiting to start Ocrevus, I had another relapse in late October. This time I alerted my MS specialist first and had my husband drive me the hour plus to their office. The next day I started steroid infusions which resolved almost all the new symptoms and even some of the lingering ones in my vision from the April episode. But I still can’t walk even short distances in the house without aid and have not been able to drive...both things I was able to do previously. And now need a scooter or wheelchair for any distance more than 30 feet or so. It would have been nice to know of this risk when my doctor asked me to stop taking Gilenya in March because of liver issues. I do not view it as a scare tactic. I would have suspected a MS episode immediately in April and alerted the emergency room staff. I was without a DMT for a number of months. It took several months for my lymphocyte count to stabilize and another couple of months for my insurance company to approve the change and to schedule the first Ocrevus infusion. Despite this being rare, it is a real risk that needs to be known. One neither my doctor or I knew I was taking at the time. And for many of us, these drugs are our last chance to stop or slow progression. I’m 64 and have tried a lot of ways to combat this disease with little or no change. Gilenya was effective except for the liver enzyme problem. I expect Ocrevus to be effective too. And yes, I’ll take the chance of side effects. Reply Ed Tobias Hi Christine, I'm so sorry to hear about the problems you had. Thanks for providing all of that info, which may be very useful for others to learn. I've read many positive reports from people who are being treated with Ocrevus and I hope that it also works well for you. Ed Reply Stephanie Hendrix In April my new neurologist (Now old) told me that she doesn't want me on Ocrevus bc there had been 50 deaths in the first year. She didn't give me a choice. And ignored the fact that people on the Ocrevus fb group have reported wonderful things, like being able to jog now. I go to my new neurologist in December and not sure if I should say anything. And now learning about the side effects from stopping Gilenya I'm even more alarmed. Do you have any suggestions? Thank you, Stephanie Reply Ed Tobias Hi Stephanie, All DMTs have their risks and their benefits. When I moved off of Aubagio,and onto Lemtrada, my neuro gave me a choice of three DMTs and explained the risks and benefits of each. I wouldn't use a neuro who didn't give me a choice of treatments, when there are so many for MS. I think you should insist on having a discussion about which treatment is the right one for you when you see your new neuro. BTW, I'd question your old neuro's statement regarding 50 deaths in the first year. The best info I've been able to find is on the Multiple Sclerosis Association of America's website. It reports 32 deaths through the end of 2017, including 8 during clinical trials. But none of them has been DIRECTLY linked to Ocrevus: "...as of December 2017, the post-marketing surveillance of Ocrevus had recorded 24 deaths among the 30,000 patients who have been treated with the medication worldwide (an additional eight people died during clinical trials that involved roughly 2,000 participants). The causes of death have been varied, and in some cases unknown, with no cancer deaths reported. While physicians, regulators, the medication’s manufacturers, and others are monitoring the post-approval efficacy and safety profile of Ocrevus, it is very difficult at this point to discern the significance, if any, of these data." Please keep us posted on how things go for you. Ed Reply Kevin I started taking Gilenya in June of 2016 when it was determined that Rebif was no longer effective for me. I had a very mild limp at the time and had gone a few years without and major disability issues. During the 1 and 1/2 years that I was on Gilenya, I developed new lesions and my functionality started to decline. I was taken off Gilenya in Dec of 2017 and started Ocrevus a couple of weeks later. In the past year, my disability has continued to decline and I was recently assessed to be 75% disabled and I feel it getting worse. I understand when the writer says to heed side effect warnings of medication, but I don’t ever remember seeing the possibility of rapidly increasing disability as a side effect of Gilenya when I started taking it. Reply Ed Tobias Hi Kevin, You're right. This advisory from the FDA is reporting a effect that they're now concerned about. As far as I know, this wasn't known until recently. I'm very sorry for your decline and hope that Ocrevus will be able to turn things around for you. Ed Reply Emily I would like to add to the if you're a healthcare professional list: 1. If you're a healthcare professional and someone calls and states, "I just moved here. I'm on Gilenya and I will be out of medication in 3 weeks. Can I please have an appointment?" The response should be, "we will work you in next week". It shouldn't be, "see you in 3 months". I was off of Gilenya and had a relapse. I'm not sure I deserve all of the blame for going off of it. They had all of my medical records and knew that I had MS and was taking Gilenya. It's really hard to stay on a medication if you need a provider to prescribe it for you and obtain the pre-auth from the new insurance. Reply Ed Tobias That's an excellent point, Emily. Far too often I hear of people who can't get a fast response from, or an appointment with, a physician when they really need one. That's horrible patient care. I'm going to write something about this problem in one of my future columns. Ed Reply Sarah ryan I started taking gilenya in 2011 and travelled very well on it with only a few new lesions until 2018. I had to discontinue use when my lymphocyte blood count became dangerously low. Almost immediately after stopping I was hit with the worst run of rebounds I have ever head with only two days in between each one including three weeks of oscillapisia with my eyes , blind spots in vision and then full leg numbness , weakness leaving me hobbling with a stick . I feel angry that this information on rebound effect was not available until 2015 . My ms is so much worse then it has ever been . Before stopping as a mother of four children I worked full time run my house and even took my children on a round the world trip. Now I struggle to walk up the stairs at home ?. My ms team put me in tysabri and my world got even worse with my flare increasing leaving me in hospital for a week ! I had instant back pain , no feeling from the chest down , numb hands and the ms hug. I live as a gluten free vegan and have always had a positive outlook towards life . I have since read if you have tysabri infusion whilst in an active flare it can make it worse. I had neuropathic pain in my back and legs and have now been taken off tysabri too. I have learnt to educate myself and follow my heart and to try not to make decisions about ms treatment from a place of fear . Good luck to all out there that are working towards a better lighter future with ms , May we all find our rainbow. As for me diet, meditation and feeling the trust I have in my body again will be my new drug of chose for a while Sarah Reply Ed Tobias Dear Sarah, Thanks for sharing all of this. I'm very sorry for all of the difficult that you've had over the years and I hope that you're able to find a way to deal with MS that works best for you. Regards, Ed Reply Brendan Burke I was diagnosed with MS in 2017 and started on Gilenya shortly after dx, everything was going well until a red swirl mark on my leg wasn't healing/fading, my GP sent to to a consultant dermatologist, he examined and later did a biopsy. The results came back showing Karposi's Sarcoma... I'd cancer. The only people who get KS are those who have Aids or are on immune suppressant meds. Blood tests confirmed that I'm Hiv negative, so Thanks Gilenya for the cancer. My Neuro said to stop Gilenya immediately, I did, and after a few weeks I noticed that my balance, fatigue and reading vision get progressively worse. Hopefully after 2 sets of Radiotherapy treatments I will be able to start on Tecfidera shortly. But as I maintain: I may have MS, but it doesn't have me! Reply Ed Tobias Hi Brendan, I'm sorry for all of the problems that you've had and I hope that you can find a successful treatment for both your MS and your KS. I think your "it doesn't have me" attitude is almost as important as any medical treatment, so keep it up. Ed Reply Kimon Ganiatsos I am a 61-year old MS patient, first diagnosed forty years ago, and have been relapse free for over 20 years. I have been taking Gilenya for approximately ten years. Prior to that I was taking Rebif. As soon as I was eligible I got my two Pfizer vaccine shots and , in mid-August, my booster shot. From the get go I remained concerned over the efficacy of the vaccine, given that I take an immuno-suppressant. So this past week I shared my concerns with my primary physician who ordered up an antibody test for me. The test came up negative, confirming my worst fears. I believe Gilenya is the culprit. My neurologist has stated that at my age, having remained symptom-free for so long, I am "out of the woods" and that we might be able to consider discontinuing Gilenya. After having taken myself out of the workforce for nearly two years, continuing to live in a virtual bubble is no longer an option. I would welcome your thoughts on this matter. Thanks. Reply Ed Tobias Hi Kimon, I was diagnosed with MS over forty years ago and have been treated with Avonex, Tysabri, Aubagio and Lemtrada. My second Lemtrada round was completed four years ago. After Round 2 I was tested for antibodies and registered greater that 2,500, which is a significant number. I know that some DMTs, primarily Ocrevus, are believed to reduce the efficacy of the COVID-19 vaccines. The National MS Society says Gilenya MAY be among them. Here's a list of its DMT recommendations: https://www.nationalmssociety.org/coronavirus-covid-19-information/multiple-sclerosis-and-coronavirus/covid-19-vaccine-guidance/Timing-MS-Medications-with-COVID-19-Vaccines But, this is important, the Food and Drug Administration says "results from SARS-CoV-2 antibody tests should not be used to evaluate immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination." https://www.fda.gov/news-events/press-announcements/fda-brief-fda-advises-against-use-sars-cov-2-antibody-test-results-evaluate-immunity-or-protection So, it seems as if you may be overreacting to the test results. Bottom line, it's a decision between you and your neuro. Ed Reply Kimon Ganiatsos Ed, Thanks for your reply. I will definitely check out the links you provided. My girlfriend shares your view that perhaps I am overreacting. But I am Greek; overreacting comes naturally to me. Lol! 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