Page 1 of 2 12 LastLast
Results 1 to 10 of 17

Thread: Novartis announces 3rd case of PML with Gilenya

  1. #1
    Distinguished Community Member Cherie's Avatar
    Join Date
    Oct 2006
    Location
    Southeastern NE
    Posts
    1,644

    Default Novartis announces 3rd case of PML with Gilenya

    Aug 17, 2015
    Novartis has been informed of a third case of progressive multifocal leukoencephalopathy (PML) in a patient with relapsing MS (RMS) treated with Gilenya without prior exposure to natalizumab treatment. The patient also has a history of colorectal cancer treated with chemotherapy and radiation treatment in the past as well as Crohn’s disease (an inflammatory bowel condition).

    The diagnosis of PML was based on suggestive clinical symptoms, MRI findings and tests for JC (John Cunningham) virus. Health Authorities have been informed of the case. Novartis is in active discussions with external advisors to review details of this case and the role of various risk factors contributing to the development of PML.

    Patient safety is of paramount importance for Novartis and we recently updated the Gilenya prescribing information, in collaboration with Health Authorities, to increase vigilance for PML.

    With more than 125,000 patients treated with Gilenya and 240,000 patient years of exposure in both clinical trials and post-marketing setting, Novartis continues to stand behind the positive benefit-risk profile of Gilenya in relapsing MS.

  2. The following 6 users say "thanks"


  3. #2
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    8,482
    Blog Entries
    15

    Default

    I don't know if this earlier thread adds much more information but FWIW:

    http://www.braintalkcommunities.org/...nya-drug-label
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  4. The following 5 users say "thanks"


  5. #3
    Distinguished Community Member Howie's Avatar
    Join Date
    Oct 2006
    Location
    The planet Earth
    Posts
    6,805

    Default

    I wonder how that patient even qualified to use Gilenya given their past medical history.

  6. The following 4 users say "thanks"


  7. #4
    Distinguished Community Member
    Join Date
    Oct 2006
    Location
    North Carolina
    Posts
    4,693

    Default

    Good point Howie!
    Virginia

  8. The following 4 users say "thanks"


  9. #5
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    8,482
    Blog Entries
    15

    Default

    I have an impression that doctors are very eager to keep their patients happy, and sometimes whatever the patient wants, the patient gets. The patient (or his/her family) might have really leaned on the doctor to prescribe Gilenya. I've heard that this happens.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  10. The following 3 users say "thanks"


  11. #6
    Distinguished Community Member Howie's Avatar
    Join Date
    Oct 2006
    Location
    The planet Earth
    Posts
    6,805

    Default

    But the doctor takes the Hippocratic Oath, "Do no harm". Seems that was overlooked. Pleasing a drug company clouded the doctor's vision IMHO.

  12. The following 4 users say "thanks"


  13. #7
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    8,482
    Blog Entries
    15

    Default

    Some doctors genuinely want to please their patients. After all, they want to keep those patients. They don't want us going to the doctor down the street instead.

    And some of them will let the patients write their own tickets.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  14. The following 3 users say "thanks"


  15. #8
    Distinguished Community Member Howie's Avatar
    Join Date
    Oct 2006
    Location
    The planet Earth
    Posts
    6,805

    Default

    I agree, but it's not right. I don't think ANY drug that has resulted in PML should continue to be used, especially on one who had gotten Chemo, which strips the immune system hoping it had weakened the immune system enough to cause it not to attack the remaining immune system of the patient. I wonder how long after using Chemo they waited.

    Where's SpongeBob?
    Last edited by Howie; 08-26-2015 at 12:40 PM.

  16. The following 3 users say "thanks"


  17. #9
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    8,482
    Blog Entries
    15

    Default

    I agree with you. I'm all for doctors who let their patients make the decisions but there are times when a doctor needs to step in and emphatically advise the patient not to go a certain route or even refuse to prescribe a drug that the patient is insisting on.

    PML is too terrible a disease to risk getting. At least I wouldn't want the risk. Others don't feel that way.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  18. The following 4 users say "thanks"


  19. #10
    Distinguished Community Member Howie's Avatar
    Join Date
    Oct 2006
    Location
    The planet Earth
    Posts
    6,805

    Default

    I'm with you Joan, if PML is even a chance with a certain treatment, I would have to say no thanks.

  20. The following 4 users say "thanks"


Page 1 of 2 12 LastLast

Similar Threads

  1. 2nd PML case in MS patient taking Gilenya
    By agate in forum Multiple Sclerosis
    Replies: 9
    Last Post: 06-29-2015, 01:37 PM
  2. Replies: 0
    Last Post: 03-06-2012, 10:44 PM
  3. Replies: 6
    Last Post: 01-21-2012, 05:23 PM
  4. Gilenya
    By Turtle in forum Multiple Sclerosis
    Replies: 4
    Last Post: 01-01-2012, 05:40 PM

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  


BTC Inc's Disclaimer and Privacy Policy

The material on this site is for information & support purposes only, and is not a substitute for medical advice provided by a licensed health care provider. Always consult your doctor before trying anything that you find online.