Earlier this year we posted on the Drug Injury Watch blog these two 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
Now, as regards a different set of side effects, in September 2015 Health Canada issued this document, “GILENYA (fingolimod) – Abnormal Tissue Growth (Neoplasms)”, from which we obtain the following drug safety information:
- 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.
And later that document provides these conclusion points 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.
We will continue to monitor side effect information involving Gilenya, as will Health Canada.[Read this article in full at original source]
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