Makers of Xarelto Sued for Internal Bleeding

Lawsuits have been filed in state and federal court by plaintiffs who suffered serious internal bleeding after taking Xarelto. The anti-clotting drug is manufactured by the German drug giant Bayer. Xarelto is distributed in the U.S. by Johnson & Johnson subsidiary Janssen Pharmaceuticals.

Xarelto is a blood thinner. The anti-clotting drug is one of Bayer’s top five medicines and it earned $1.3 billion in sales last year.

The lawsuits charge that the companies failed to warn users that Xarelto could result in irreversible internal bleeding. Xarelto has been marketed as a more convenient choice than warfarin (Coumadin), which is used as an anticoagulant in the U.S. since the 1950s. Warfarin requires patients to take frequent blood tests and follow a strict diet. However, warfarin’s anticoagulation is reversible by administering Vitamin K. Xarelto does not have a known reversal agent and many of the serious bleeding incidents have led to death.

Pradaxa is a similar blood thinner to Xarelto, and its manufacturer Boehringer Ingelheim agreed last Spring to settle 4,000 lawsuits for $650 million. Those plaintiffs claimed Pradaxa caused severe and sometimes fatal bleeding. Since Xarelto and Pradaxa have similar side effects, the evidence is now piling up against Xarelto.

Last May, the Institute for Safe Medicines Practices, which monitors all domestic serious adverse drug events reported to the FDA, noted increased reports about Xarelto. Its report stated “Anticoagulant drugs are a high-risk treatment and cause bleeding in approximately 15% of patients with atrial fibrillation exposed for a year.”

The latest reports of adverse effects showed a trend associated with two of the newer anticoagulant drugs: dabigatran (Pradaxa) and rivaroxaban (Xarelto). The Institute shows that reported cases for Xarelto were steadily increasing and had overtaken the reports for Pradaxa.

The Institute thought the new trend could be mostly explained by a major change in the number of patients exposed to the two drugs. The total dispensed prescriptions for Xarelto have increased to close to one million per quarter, while Pradaxa prescriptions have steadily declined since they peaked in early 2012.

A Johnson & Johnson spokesman told the Wall Street Journal, “The risk of bleeding, a known side effect for all blood thinners, is clearly highlighted in the warnings and precautions of the Xarelto prescribing information.”