Summary Safety Review - Aubagio (teriflunomide) - Assessing the potential risk of sudden kidney injury or kidney stones

August 4, 2017

Product

Aubagio (teriflunomide)

Potential Safety Issue

Sudden onset of kidney injury (acute renal injury) or formation of kidney stones (nephrolithiasis)

Key Messages

  • Aubagio (teriflunomide) is a prescription drug authorized for sale in Canada to treat patients with multiple sclerosis (MS). Aubagio helps to reduce the number of flare-ups (relapses) and slows the worsening of physical problems and other symptoms associated with MS.
  • Following the receipt of new safety information from the manufacturer, Health Canada reviewed the potential risk of sudden onset of kidney injury or formation of kidney stones with the use of teriflunomide.
  • Health Canada’s review of the available information did not establish a link between the use of teriflunomide and a risk of sudden onset of kidney injury or formation of kidney stones. Health Canada will continue to monitor the safety of teriflunomide.

Overview

Health Canada reviewed the potential risk of sudden onset of kidney injury or formation of kidney stones with the use of teriflunomide because of safety information received from the manufacturer. Patients with MS, in general, may be at a greater risk of experiencing problems with their kidneys than healthy people.

Use in Canada

  • Aubagio (teriflunomide) is a prescription drug authorized for sale in Canada to treat patients with MS. Aubagio helps to reduce the number of flare-ups (relapses) that happen and slows the worsening of physical problems and other symptoms associated with MS.
  • Teriflunomide has been marketed in Canada since 2013, under the brand name Aubagio. It is available as a tablet that is taken by mouth.

Safety Review Findings

  • At the time of the review, Health Canada received, from the manufacturer’s worldwide database, 55 reports (all were international) of suspected sudden onset of kidney injury and 135 reports (8 of these were Canadian) of suspected kidney stones with teriflunomide use.Footnote 1 No additional reports were found in Health Canada’s Canada Vigilance database.
  • Upon review of the above information, only 2 reports of patients with sudden onset of kidney injury were considered to be possibly related to the use of teriflunomide. The review of reports of kidney stones did not show a link related to the use of teriflunomide. In these reports, other factors could have played a role, such as the MS itself or problems with the bladder. There was also limited information in the reports that described the health of the patient’s kidneys before taking teriflunomide.
  • In the published scientific literature, there were no reports or studies related to the possible association of sudden onset of kidney injury or formation of kidney stones with the use of teriflunomide.
  • There was limited evidence to suggest that MS patients may be at greater risk of kidney injury or forming kidney stones when taking teriflunomide.

Conclusions and Actions

  • Health Canada’s review of the available information did not establish a link between the use of teriflunomide and a risk of sudden onset of kidney injury or formation of kidney stones.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of this/these health product(s).
  • Health Canada will continue to monitor safety information involving teriflunomide, 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

Footnote 1

Canadian reports can be accessed through the Canada Vigilance Online Database

Return to footnote 1 referrer

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