Summary Safety Review - AUBAGIO (teriflunomide) - Assessing the potential risk of inflammation of the colon (colitis)

June 28, 2017

Product

AUBAGIO (teriflunomide)

Potential Safety Issue

Inflammation of the colon (colitis)

Key Messages

• Aubagio (teriflunomide) is a prescription drug authorised for sale in Canada to treat patients with multiple sclerosis. Aubagio helps to reduce the number of flare-ups (relapses) that happen and slow the worsening of physical problems and other symptoms due to multiple sclerosis.
• Health Canada reviewed the risk of inflammation of the colon (colitis) with the use of teriflunomide after finding reports of colitis (since being marketed) as part of routine review of information received from the manufacturer. Also, the product safety information of a closely-related drug, Arava (leflunomide) was updated to include a new warning for colitis.
• Health Canada’s review of the available information concluded that a link between Aubagio use and colitis could not be confirmed at this time. However, Health Canada will work with the manufacturer to update the product safety information to note that reports of colitis with Aubagio use have been received.

Overview

Health Canada reviewed the potential risk of colitis with Aubagio use after finding reports (since being marketed) of colitis as part of routine review of information received from the manufacturer. Also, the product safety information of a closely-related drug, Arava (leflunomide) was updated to include a new warning for colitis. In Canada, the product safety information for Aubagio does not mention the risk of colitis.

Use in Canada

• Aubagio (teriflunomide) is a prescription drug authorised for sale in Canada to help reduce the number of flare-ups (relapses) and to slow the worsening of physical problems and other symptoms in patients with the relapsing remitting form of multiple sclerosis.
• Aubagio (teriflunomide) has been marketed in Canada since 2013 and is available as a capsule that is taken by mouth.

Safety Review Findings

• At the time of the review, Health Canada had received 3 reports of colitis related to Aubagio use. Upon analysis of these reports, Health Canada concluded that 2 of the 3 reports were possibly related to the use of Aubagio. There was not enough information included in the third report to support a possible link.
• Nine additional reports of colitis (3 Canadian and 6 international), reported to Health Canada by the Canadian manufacturer of Aubagio were also assessed. Health Canada concluded that all 9 reports were possibly related to the use of Aubagio.
• A search of the scientific literature found 1 report of colitis in a patient using Aubagio. However, there was not enough information in this report to assess the link between colitis and the use of Aubagio.
• To date, there is no suggested way to explain how Aubagio could cause colitis.
• While some reports of colitis assessed above were found to be possibly linked to Aubagio use, other factors may have also contributed to this risk. These factors included the disease being treated (multiple sclerosis), the use of other medications at the same time or other health problems (for example, bowel inflammation).

Conclusions and Actions

• Health Canada’s review of the available information concluded that a link between Aubagio use and colitis could not be confirmed at this time. However, Health Canada will work with the manufacturer to update the product safety information to note that reports of colitis with Aubagio use have been received.
• 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 side effect information involving Aubagio, 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 information and what is known about the use of this health product both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.