Health Canada recently revealed that it had undertaken a safety review of Xarelto, after the blood thinner had been named in dozens of liver injury reports. So far, the regulator has been unable to establish a clear link between Xarelto and those injuries, but it is encouraging doctors and patients to report any liver-related harmful affects that may be tied to its use.
The liver injury reports reviewed by Health Canada included 61 cases logged by the Canadian Vigilance Program, and another 431 included in the World Health Organization’s (WHO) database. A number of reports were also gleaned from the scientific literature. Health Canada was unable to establish any clear links with Xarelto because many of the reports collected by the databases were incomplete. In some of the cases reported in scientific literature, patients had underlying liver diseases before using Xarelto, or were taking other medications that may have contributed to their injury.
Health Canada also noted that Xarelto’s Canadian prescribing information warns against the use of the medication in people who have liver disease linked to problems with blood clotting, and who have a risk of bleeding.
In the U.S., Xarelto is the subject of hundreds of product liability claims filed on behalf of individuals who allegedly experienced uncontrollable bleeding and other serious complications associated with its use. The majority of these claims have been filed in a multidistrict litigation currently underway in the U.S. District Court, Eastern District of Louisiana, where trials are expected to get underway next year. Hundreds of additional cases are pending in a mass tort proceeding underway in Pennsylvania’s Philadelphia Court of Common Pleas.
In the U.S., Xarelto is approved for the prevention of strokes in people with atrial fibrillation; the treatment of deep vein thrombosis and pulmonary embolism; and the prevention of deep vein thrombosis in patients undergoing hip or knee replacement surgery. As is the case with any blood thinning medication, Xarelto can sometimes cause episodes of serious internal hemorrhaging. However, there is currently no approved antidote to reverse this occurrence. Xarelto’s label also includes a black box warning that contains information about the increased risk of blood clot formation after premature discontinuation of the medication in the absence of adequate alternative anticoagulation.
Xarelto lawsuit plaintiffs charge that the drug’s manufacturers induced doctors to prescribe the medication by marketing it as a superior alternative to warfarin, a blood thinner that has been in used for decades. Among other things, they point out that bleeding from warfarin can be reversed via the administration of vitamin K.
The Xarelto lawyers at Bernstein Liebhard LLP are now accepting case inquiries from individuals who experienced dangerous internal bleeding or other complications that may be related to their use of this medication. To learn more, please call (888) 979-1182.