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January 20th, 2012
06:44 PM ET

MS drug Gilenya under safety review

Health agencies on both sides of the Atlantic are investigating reports of 11 deaths in multiple sclerosis patients taking Gilenya, the first multiple sclerosis drug approved in pill form. 

The U.S. Food and Drug Administration confirmed Friday that it is studying data on Gilenya (fingolimod).  "We will notify the public once our review is complete to communicate any recommendations or possible label changes," the FDA said in a statement to CNN.

The investigation comes on the heels of the European Medicines Agency  announcing, that they are reviewing the drug, after reports of several deaths from heart problems in patients.

Gilenya was approved for the treatment of relapsing-remitting multiple sclerosis in 2010.  The FDA recommends that before patients start on the drug, they are made aware of potential heart-rate problems.  The agency further recommends that patients only take Gilenya at their physician's office , where they are monitored for six hours after they take the first dose.

The Swiss pharmaceutical company Novartis says last November it was "notified of the first reported case of a patient death that occurred within 24 hours after receiving the first dose of Gilenya."  In a statement to CNN, the company says the cause of death remains unknown.  Ten more patients taking the medication have died, due to sudden death, heart attack or disruption of the heart rhythm, according to Novartis.  "As noted by EMA, it is currently not clear whether these deaths were caused by Gilenya or not," 

The company points out that in clinical trials, there was not an imbalance in deaths of patients on the drug and incidents in the general population.

The National Multiple Sclerosis Society notes that it unclear what role Gilenya may have played in these deaths and is waiting for the results of the investigation.  Dr. Timothy Coetzee, chief research officer for the National MS Society, says "understanding the benefits and risks of therapies is vitally important to everyone in the MS community."

In addition, the organization stresses the importance of the EMA's recommendation for heightened monitoring procedures after the first dose is administered.

The MS Society recommends patients currently taking this drug consult their doctor or contact the Novartis patient support line at 888-NOW-NOVA (888-669-6682) for more information.


soundoff (13 Responses)
  1. Kell

    I am really glad I decided not to join the study for that medicine,would be very happy for MS to go away as much as possible but not through death........

    January 20, 2012 at 19:12 | Report abuse | Reply
  2. Sherri

    I have been on Gilenya since about August or Sept 2011. I have had many chest pains and I mentioned the condition to my doctor on more than one occasion but there seemed to be no concern. I am so happy that I've heard of these deaths in time to hopefully prevent my own death. I knew something was severely wrong. The chest pains are very scary. I will quit the Gilenya today and contact my physician first thing Monday.

    January 21, 2012 at 12:46 | Report abuse | Reply
  3. Erica

    I have been on Gilenya since mid summer and I was just in the breakroom at my job and just saw where this news came up on the television. I have not had any problems since I've been on this drug and hopefully this wont bring any. This is the best thing for me because I dont like taking shots but if it's between life and death I will have to pick something else to take.

    January 21, 2012 at 13:30 | Report abuse | Reply
  4. Bev

    I AM one who is living at this moment w effects! Gradual decline since last May.. What stopped my taking the drug is the almost unbearable headache which I ended up in hospital w BP 222/91 on a Fri. Headache continues, except one day,with drugs help to suppress pain i am not in hospital now. Ended up in hospital again w numbness left side body, headache bad on next Sat., Jan 14, 2012. The effects were so gradual till the super headache hit me. My husband started reading the effects of Gilenya...mine there.

    January 22, 2012 at 12:39 | Report abuse | Reply
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  6. Jer

    Every treatment for MS has severe adverse effects and serious/fatal risks. I have been on two; which nearly took my life. Since then I refuse to take any so-called treatment by a wealthy pharmaceutical company whose studies have never been long-term. I only use the alternative approach and I have been living with MS for 20 years; though I suffer from the horrendous nerve and muscle spasm pain; which am only treated for muscle spasm – not pain, because they are "addictive", yet I am living alone, independent and still able to function without the use of aid. We have been waiting for decades for a CURE FOR MS, yet due to our cuts for vital research funding and wealthy pharmaceutical companies, all we ever get is another toxic treatment; which continues to put your life in danger.

    January 24, 2012 at 04:09 | Report abuse | Reply
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    January 28, 2012 at 19:48 | Report abuse | Reply
  8. Not a Fan of Pharma

    I don't trust Big Pharma one bit. They use fear to sell their products, pandering their snake oil to physicians who in turn prescribe it to patients with so many physical issues (numbness, fatigue, tingling hands and feet, optic neuritis, etc...) and the patient is just hanging onto hope that something will work. I agree with "Jer," who posted above. Plus, I don't like the tone of the Gilenya spokesperson, saying the patient is supposed to take the pill in a doctor's office. What?? You take the FIRST pill in a medical setting and after that, you're at home when you take it. They'll sell dangerous snake oil and then blame the patient when they die from it. "Oh, we told you there were possible adverse side effects!" But then they turn around and use Fear to sell it, and guilt. It's as if they put out in their ads to take their drugs or your prognosis will be far worse. I feel bad for those people who had heart attacks. And I don't trust these Big Pharma companies. Live our lives well, decrease our stress, eat healthy food, stretch and get some exercise when we can. Let's not take every drug they try to sell us.

    February 4, 2012 at 23:45 | Report abuse | Reply
  9. Jennifer Craver

    I have been on Gilenya for 7 months. Haven't talked to my doctor (yet) about back pains. Not all pain but stiffness in back. (Could be from lousy posture I have acquired with my MS.)
    Just curious what others may have experienced and why would drug cause the problems.

    March 17, 2012 at 20:37 | Report abuse | Reply
  10. Gillian

    I was on gilenya since June 2011 and also experienced back pain along with a huge increase in blood pressure. I just found out yesterday after a doctor's visit about the gilenya deaths and I stopped taking it. It never felt right to me and I should have listened to my body earlier. Everyone should do what is right for them and I know that this is right for me.

    March 21, 2012 at 20:20 | Report abuse | Reply
  11. LYNNE HEAL

    this is MANSLAUGHTAR to human beings and many people are accountable many

    November 12, 2012 at 19:06 | Report abuse | Reply
  12. LYNNE HEAL

    many people should be made accountable for deaths of MS patients who have been prescribed bad drugs , its like DRUG PUSHING which many are jailed for

    November 12, 2012 at 19:08 | Report abuse | Reply
  13. Carolyn Sheets

    My doctor really wants me to start Gilenya. I have taken shots three times a week since mid 2008. My body feels like a pin cushion and I am scarred from so many shots as I am sure are many MS patients. My symptoms are now getting worse and my doctor is very convincing that this medication change could produce good results. I resisted Tysabri and I am so glad I did. I was led to believe it was a bad drug and I think my cautions have been justified. I am on the verge of caving in to the Gilenya. My concern is that it has not had sufficient time to have been proven safe. I used to trust the MS professionals and do whatever they instructed. Now I am really questioning whether I am just an expendable medical experiment for the advancement of science and to line their pockets with drug company money. I still do not know what to do concerning Gilenya. I am asking the Lord to guide me to a decision only He can make with true wisdom and loving-kindness. I know He really cares about me and my family.

    May 5, 2013 at 12:11 | Report abuse | Reply

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