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Potential Link Between MS Drug Gilenya And Cancers, Neoplasms, Or Tumors According To Health Canada

This September 2015 Drug Safety Alert Is Based Primarily On Reports Of Skin Cancer And Lymphoma Blood Cancer

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Health Canada recently conducted a review of safety information obtained from the drug company Novartis Pharmaceuticals Corporation, the manufacturer of Gilenya (fingolimod), about a potential link between the use of this multiple sclerosis (MS) drug and certain types of cancers and malignant tumors or neoplasms.

As a result, on September 14, 2015 this Canadian drug regulatory agency issued this document, "GILENYA (fingolimod) – Abnormal Tissue Growth (Neoplasms)", from which we obtain the following overview of this new potential safety issue:

Health Canada's safety review showed evidence of a potential link between the use of Gilenya and an increased risk of lymphomas and other malignant cancers, particularly of the skin. The Canadian product monograph for Gilenya has been updated to include this information. Health Canada has requested additional safety information from the manufacturer and will continue to monitor this issue.

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From that same Health Canada document we get these additional points concerning this emerging drug safety issue concerning Gilenya:

  • At the time of the review, the Canada Vigilance program received 16 reports of neoplasms linked to Gilenya. There were no life-threatening events or deaths reported, and no more than two cases were reported for any particular type of cancer, including skin cancer and a type of blood cancer (lymphoma).
  • The World Health Organization's database presented 62 cases of skin cancer at the time of the review. Eight or fewer cases of each remaining non-skin cancer were reported, with the exception of breast cancer where there were 30 cases.

That document later provides this concluding information about Gilenya, lymphomas, and other cancers:

  • Health Canada's safety review showed evidence of a potential link between Gilenya and the increased risk of lymphomas and other malignant cancers, particularly of the skin.
  • The Canadian product monograph for Gilenya has been updated to include the risk of lymphomas and other malignant cancers, particularly of the skin.

Earlier this year, we posted the following articles about Gilenya being associated with the side effect progressive multifocal leukoencephalopathy (PML):

August 2015 Gilenya Label Change About PML Brain Infection Follows FDA Drug Safety Alert About This Serious Side Effect

A New Case Of Progressive Multifocal Leukoencephalopathy (PML) In A Patient Using Gilenya Is Reported By Novartis In Canada

We will continue to monitor side effect information involving Gilenya, as will Health Canada.

 

DrugInjuryLaw.com: Legal & Medical Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation – Free. Confidential. No Obligaion.  (Case review done by attorney Tom Lamb)

7 responses to “Potential Link Between MS Drug Gilenya And Cancers, Neoplasms, Or Tumors According To Health Canada”

  1. Gemma Avatar
    Gemma

    Hello my name is Gemma I have ms and I have been on the drug gilenya for just over a year, last week I went to my local beauty shop to get my eyebrows shaped. While there the skin specialist noticed a shinny sore on my nose, she said it wasn’t a spot and to get it checked, iv had it for about 2 weeks and it came from nowhere, it’s now looks like a dark patch with crusty bits on it, I do use tanning beds as I thought the vitamin d helps my ms. I’m really worried. I’ll look forward to hearing back from you.
    Kind regards
    Gemma

    Reply
  2. Tom Lamb Avatar
    Tom Lamb

    Thank you for your Comment.
    Please understand, however, that because I am not a physician but only an attorney I am not in a position to give any medical opinion as regards your situation.
    I wish you the best in all aspects going forward.
    Tom Lamb

    Reply
  3. Jody Briggs Avatar
    Jody Briggs

    Hi:
    My sister died on 7/23/09. She was diagnosed with MS at 15 yrs of age (1971) and lived until her 53rd birth day (7/23/09). She died of a blood cancer though I am not sure which one. The onset of the cancer was quick and by the time she was diagnosed, she virtually had no white blood cells and was bleeding out. As I am now facing the possibility of an MS diagnosis, this evening I started doing some online research and found that one of the side effects of Mitoxantrone (Novantrone®) and Fingolimod (Gilenya®) is blood cancer. I know she took oral medication as well as a medication she injected herself. I also know one of the drugs she took was an experimental drug that she obtained directly from the drug company. I have asked my mother to check to see if she took Mitoxantrone (Novantrone®) and/or Fingolimod (Gilenya®). Please be advised that my sister did not have the capacity to understand the side effects or give informed consent. She was diagnosed with schizo affective disorder or schizophrenia (both diagnoses given at different times by different doctors) in the early 1990’s.
    I would have looked into this before but did not know that the drugs she was taking for MS could possibly be related to the cause of her death.
    My sister had 4 children that she left behind. Her youngest has Asberger’s and lives with my parents who are in their 80’s. Any help you can provide to her children, especially the child with Asberger’s (spelling?), would be greatly appreciated.
    Jody Briggs

    Reply
  4. Krista Avatar
    Krista

    I would like to know if it is known that Gilenya could cause cancer in a children that was born to a mom on Gilenya. I was approx 20 weeks pregnant beforebefore I found out. I was under the assumption that due to a medical procedure (un related to MS) prevented me from becoming pregnant. Please help, or lead me to someone who can.

    Reply
  5. Karen Avatar
    Karen

    I have been on Gilenya since 2011 and have been diagnosed with Breast Cancer twice – 1st time in June 2012 and again August of 2018, I’ve been trying to find out if there are any connections and see if any one else on Gilenya has been diagnosed with Breast Cancer.

    Reply
  6. elizabeth Manning Avatar
    elizabeth Manning

    Karen I started takong Gilenya and within 6 months I was diagnosed with Breast Cancer and then got Shingles while only being 44 years old. I stopped taking Gileyna. I’m very sorry you have had to deal with breast cancer twice but praise God you are still living.

    Reply
  7. jacqueline Davis Avatar
    jacqueline Davis

    Hi Karen I am reading your information I was also diagnosed with breast cancer. I don’t know if there is any correlation. I am curious as well.

    Reply

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