Summary Safety Review - TECFIDERA - Assessing the Potential Risk of Kidney Injury

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: 2017-06-15

Product

Tecfidera (dimethyl fumarate)

Potential Safety Issue

Kidney injury

Key Messages

  • Tecfidera is a prescription drug authorized for sale in Canada to treat a form of multiple sclerosis in which symptoms intensify and then decrease over a certain period of time (relapsing remitting multiple sclerosis). Tecfidera helps to reduce the number of flare-ups (relapses) that occur and to slow the build-up of physical problems due to multiple sclerosis.
  • Health Canada reviewed the risk of kidney injury with Tecfidera after finding international cases of this risk in patients treated with Tecfidera. These cases were found during routine review of information received from the manufacturer.
  • Health Canada's review concluded that there is little evidence at this time suggesting kidney injury was caused by the use of Tecfidera. The findings of this review are already reflected in the product information. Health Canada will continue to monitor the safety of Tecfidera.

Overview

Health Canada reviewed the risk of kidney injury with Tecfidera after finding international cases of this risk in patients treated with Tecfidera. These cases were found during routine review of information received from the manufacturer. In Canada, the product information for Tecfidera has details about possible kidney effects that were seen in animal studies, in addition to changes in urine test results seen in human studies. Based on this, monitoring of kidney function is recommended on the product information as a precaution. Potential causes of kidney injury can include not having enough fluids in the body (dehydration) resulting from nausea and vomiting, which were common in human studies with Tecfidera.

Use in Canada

  • Tecfidera is a prescription drug authorized for sale in Canada to treat relapsing remitting multiple sclerosis. Tecfidera helps to reduce the number of flare-ups (relapses) that happen and to slow the build-up of physical problems due to multiple sclerosis.
  • Multiple sclerosis is a deteriorating disease in which the immune system attacks the protective cover (myelin) of the nerves to interrupt communication between the brain and spinal cord with the rest of the body.
  • Tecfidera has been marketed in Canada since April 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 a total of 5 Canadiana reports of potential serious kidney injury from any cause (such as dehydration or damage to the kidney itself) with Tecfidera use. Three reports did not have enough information to confirm kidney injury. The remaining 2 reports, with one reporting death, were further assessed. While a possible link between Tecfidera and kidney injury was found in these 2 reports, other risk factors could have explained the condition, including other medication used at the same time and dehydration.
  • The safety review of 41 international reports of serious kidney injury with Tecfidera use focused on those suggesting damage to the kidney itself or those without other drugs or conditions that may cause kidney injury. As such, 40 of the 41 international reports identified were excluded from further review. The remaining report described damage to the kidney confirmed by biopsy. While a possible link was found between Tecfidera and kidney damage, another drug being used at the same time could have explained the condition.
  • A search of the scientific literature found no cases describing kidney injury in patients treated with Tecfidera.

Conclusions and actions

  • Health Canada's safety review concluded that there is limited evidence at this time suggesting kidney injury with Tecfidera. The findings of this review are already reflected in the product information. Health Canada has asked the manufacturer to provide additional safety information on this risk as it becomes available.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of Tecfidera.
  • Health Canada will continue to monitor safety information involving Tecfidera, 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

For additional information, contact the Marketed Health Products Directorate.

Footnotes

  1. Canadian reports can be accessed through the Canada Vigilance Online Database.

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