Summary Safety Review - GILENYA (fingolimod) - Assessing the Potential Risk of a Rare Brain Infection (Progressive Multifocal Leukoencephalopathy)
Review decision
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Issued: 2016-08-19
Product
Gilenya (fingolimod)
Potential Safety Issue
Rare brain infection (progressive multifocal leukoencephalopathy)
Overview
Use in Canada
- Gilenya (fingolimod) is used for the treatment of adult patients with a specific type of multiple sclerosis (relapsing-remitting multiple sclerosis) who do not respond well, or are unable tolerate other (one or more) multiple sclerosis therapies.
- Gilenya (fingolimod) has been marketed in Canada since 2011, but to date it is not widely used in Canada.
Safety Review Findings
- At the time of the review, there were 4 international case reports of suspected progressive multifocal leukoencephalopathy linked to fingolimod use that happened to patients who had not used other multiple sclerosis drugs known to increase the risk of this brain infection before. There were no Canadian case reports.
- Health Canada's review showed a possible link between progressive multifocal leukoencephalopathy and Gilenya (fingolimod). However, some of the patients had other medical conditions or used drugs, which could also be linked with progressive multifocal leukoencephalopathy.
- A search of the literature found some evidence of a link between progressive multifocal leukoencephalopathy and fingolimod use. However, more evidence was found on the risk of progressive multifocal leukoencephalopathy with other drugs used to treat multiple sclerosis.
- The product information was updated by the manufacturer on September 15, 2015 to include new warnings of the potential risk of progressive multifocal leukoencephalopathy with Gilenya (fingolimod). Health Canada's safety review did not identify any new safety concerns.
Conclusions and actions
- The safety review did not identify the need for further updates to the product information on the known potential risk of progressive multifocal leukoencephalopathy. The product information for Gilenya already warns of the potential risk of progressive multifocal leukoencephalopathy.
- Health Canada has already shared information with Canadians on the potential risks of progressive multifocal leukoencephalopathy with Gilenya, and the changes to the product information.a b
- Health Canada has requested the manufacturer to continue to provide information on this safety issue.
- Health Canada will continue to monitor safety information involving Gilenya (fingolimod), as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.
Additional information
The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.
For additional information, contact the Marketed Health Products Directorate.
Footnotes
- a Health Canada. Information Update - Multiple sclerosis drug Gilenya (fingolimod): Safety information on the risk of skin cancer and a rare brain infection. September 30, 2015. Accessed 2016-02-02.
- b Health Canada. Health Product InfoWatch October, 2015. Accessed 2016-02-02.