Health Canada has completed a safety review of Xarelto (rivaroxaban), a newer-generation anti-coagulant medication manufactured by Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson).
According to a Summary Safety Review released on August 26, 2015, the department investigated the medication after two studies showed Xarelto was linked to liver injury in 16 patients. They wanted to find out if the drug could increase risk of liver injury, but so far they don’t have a clear answer because some of the reports failed to contain complete information. Due to ongoing concerns, Health Canada has asked healthcare professionals and patients to report any liver injury that could be related to the ingestion of Xarelto.
The FDA approved Xarelto in 2011 to help reduce the risk of blood clots in patients going through hip and knee replacement surgery, and later to help reduce the risk of stroke in patients with non-valvular atrial fibrillation. The drug has been connected with an increased risk of gastrointestinal bleeding leading to hospitalization and sometimes death.
Two Studies Raise Red Flags About Xarelto Liver Injury
The two studies that alerted Health Canada to the possibility of a link between Xarelto and liver injury included the following:
1. 2014: Physicians reported in the journal JAMA Internal Medicine that two patients developed serious liver problems while taking rivaroxaban, including “massively elevated transaminase activity levels and hyperbilirubinemia.” Both recovered rapidly after they stopped taking the drug. The authors added that between 2008 and 2013, 42 cases of liver injury possibly related to the ingestion of rivaroxaban had been reported to the Swiss Agency of Therapeutic Products. They concluded that treatment with the drug could be associated with “severe, symptomatic liver injury.”
2. 2014: A second study published in the Journal Hepatology reported on 14 cases of liver injury associated with rivaroxaban. Researchers searched databases for comparable cases, and found “a considerable number of additional hepatic [liver related] adverse events where rivaroxaban was reported as a suspected cause.” The authors recommended additional studies to determine the risks of liver injury associated with the drug, and advised doctors to be on the lookout for symptoms of liver disease in patients who are taking rivaroxaban.
Concerns Remain As Investigation Continues
Health Canada noted that at the time of their investigation, the Canada Vigilance Program had received a total of 61 reports of liver-related harmful effects in patients taking Xarelto. Assessment of the cases did not reveal a clear cause-and-effect relationship, however, Health Canada pointed to the fact that some of the reports contained only partial information.
The department also reviewed international data from the World Health Organization (WHO), and found 431 cases of liver injury in patients taking Xarelto, with 23 of these patients taking “only” Xarelto, and no other medications.
One Comment
Yardley
I took it for a year and half 6 months i was bleeding everyday and hurt everywhere. And felt like 80 year old man and iam only 53 at the time. Been off almost year and half still feel weak and tired.
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