Bayer and Johnson & Johnson’s joint-effort blood thinner Xarelto has experienced rapid growth since it was introduced in 2011 and now sits atop the popular blood clot-prevention market.
At last count, the factor Xa inhibitor was being prescribed more than 2.5 million times a year in the United States, with more growth on the horizon. However, the drug has also been marred in thousands of claims of injury and death from bleeding, and named in a new mass-tort lawsuit.
Now, the Journal of the American Medical Association is reporting a new case study from Switzerland that suggests Xarelto, or rivaroxaban, may also be linked to liver damage.
Researchers at the University of Basel discovered two patients that developed liver injury soon after starting the lowest indicated dosages of Xarelto, then recovered promptly after they stopped taking it.
The first patient was a 52 year old male who was prescribed 10 mg per day of Xarelto to prevent blood clots after leg surgery. He developed hepatitis within just 60 days, and then recovered in just two weeks after stopping Xarelto.
In the second instance, doctors also noted a 73 year old female taking the same dosage to prevent clots after a knee surgery developed a liver injury, and returned to normal just two weeks after switching medications.
In both cases, the patients were taking other medications along with Xarelto. However, their liver injuries subsided when they halted Xarelto and continued the other drugs. Therefore, doctors attributed the injury in both to the blood thinner.
This new case study is troubling on several fronts. First, Although the liver injuries to both patients subsided within weeks of stopping the drug, there is no data to know whether taking Xarelto for longer periods causes permanent liver damage.
Second, the makers of the drug haven’t warned patients of possible liver injury side effects. Therefore, millions of other users may have suffered injury without knowing the cause.
The authors of the recent study have proposed additional testing of Xarelto to uncover liver dangers, as well as new warnings on the product label. DrugNews supports both suggestions.
For now, those taking rivaroxaban should consult their doctor and monitor for any signs of liver injury.
Next up for Xarelto is a judicial conference on December 4th to determine if a rapidly growing number of lawsuits over internal bleeding injury and death will be combined into one dedicated federal court.
DrugNews will continue to report on any new rivaroxaban developments.
Liakoni, E. Symptomatic Hepatocellular Liver Injury With Hyperbilirubinemia in Two Patients Treated With Rivaroxaban. Journal of the American Medical Association. (October 2014). Retrieved from http://archinte.jamanetwork.com/article.aspx?articleid=1898869
Monthly Prescribing Reference. Rivaroxaban and Liver Injury: Case Studies Add to Safety Questions. (August 29, 2014). Retrieved from http://www.empr.com/rivaroxaban-and-liver-injury-case-studies-add-to-safety-questions/article/368881/
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