Summary Safety Review - GILENYA (fingolimod) - Assessing the potential risk of decreased amounts of blood platelets (thrombocytopenia)

December 6, 2017

Product

Gilenya (fingolimod)

Potential Safety Issue

Decreased amounts of blood platelets (thrombocytopenia)

Key Messages

  • Gilenya (fingolimod) is authorized for sale in Canada to treat multiple sclerosis, a condition that leads to damage of the nervous system, causing physical disability. It is used in patients who have had a poor response to, or are unable to tolerate one or more other therapies for multiple sclerosis.
  • Health Canada reviewed the potential link between thrombocytopenia and the use of Gilenya following annual reports that were received from the manufacturer.
  • Health Canada’s safety review concluded that there was a potential link between the use of fingolimod and thrombocytopenia. The product safety information for Gilenya has been updated to inform about this potential safety issue.

Overview

Health Canada reviewed the potential link between thrombocytopenia and Gilenya following annual reports that were received from the manufacturer. Thrombocytopenia is a condition where there are not enough platelets (cells in the blood involved in clotting), which may cause too much bleeding. The impact of thrombocytopenia may be worse in patients with multiple sclerosis because of their difficulty in walking which may lead to a greater risk of falls and bleeding.

Use in Canada

  • Gilenya is authorized for sale in Canada to treat multiple sclerosis, a condition that leads to damage of the nervous system, causing physical disability. Gilenya reduces the frequency of signs and symptoms of multiple sclerosis and delays the progression of physical disability.
  • Gilenya is recommended for patients who have had a poor response to, or are unable to tolerate one or more other therapies for multiple sclerosis.
  • Gilenya was first marketed in Canada in March 2011.

Safety Review Findings

  • At the time of the review, Health Canada had received 11 unique Canadian reports of thrombocytopenia suspected to be linked to the use of Gilenya. Eight (8) reports were excluded from further review mainly because there was not enough information. A possible link between Gilenya and thrombocytopenia was found in the remaining 3 reports.
  • This safety review also looked at information from 56 international reports and 1 literature report (from the manufacturer) of thrombocytopenia associated with the use of Gilenya. Forty (40) reports were excluded from further review mainly because there was not enough information. Of the remaining 17 reports, 14 suggested a possible link between Gilenya and thrombocytopenia, and in 3 cases, thrombocytopenia was most likely due to other causes such as infection or another medication.
  • A search of the literature found some evidence of a potential link between thrombocytopenia and Gilenya use.

Conclusions and Actions

  • Health Canada’s safety review established a potential link between the use of Gilenya and thrombocytopenia.
  • The product safety information for Gilenya has been updated to inform about this potential safety issue.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of this health product.
  • Health Canada will continue to monitor safety information involving Gilenya, 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.

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: