This September 2015 Drug Safety Alert Is Based Primarily On Reports Of Skin Cancer And Lymphoma Blood Cancer
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.
Strictly Confidential, No Obligation.
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):
We will continue to monitor side effect information involving Gilenya, as will Health Canada.