Health Canada Continues to Monitor Liver Injury Related to Xarelto®

Health Canada, the regulatory body responsible for drug safety in Canada, recently conducted a safety review of Xarelto® after learning of 16 reports of patients who suffered liver injury associated with the use of Xarelto®. Those reports were contained in two articles published in two respected scientific journals in 2014.

In August, 2015, Health Canada announced the results of its safety review of Xarelto® concluding that:

A clear link between liver injury and the use of Xarelto® could not be established because the information in some of the Canadian and International reports was incomplete. Also, in some of the reports published in the scientific literature, patients had underlying liver diseases before using Xarelto® or were taking other medications that may have contributed to the liver injury… The current safety review did not establish a clear link between the use of Xarelto® and liver injury.

During its safety review, Health Canada identified "…61 Canadian reports of liver-related harmful effects (adverse events) in patients taking Xarelto® that were received throughout Canada." In addition, Health Canada reviewed "…international data from the World Health Organization's database [that] showed 431 cases of liver injury, and Xarelto® was reported as the only drug used in 23 of these cases."

In announcing these results, Health Canada indicated that it will publish an article "…to raise awareness and to encourage the reporting of liver-related harmful effects that may be linked to the use of Xarelto®."