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

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.

Publisher

Health Canada

Resources

2

Catalogue metadata updated

2024-05-10