Xarelto, Eliquis Manufacturers Claim Blood Thinners Safe in Dueling Studies

The makers of the new blood thinners Xarelto and Eliquis released new studies this week that tout the alleged safety of their medications, even as they face a growing number of lawsuits filed by users who suffered severe and uncontrollable bleeding injuries. 

The studies were presented at a conference of the European Society of Cardiology last weekend, and both claim to show “real world” use of the drugs and their safety risks.

Johnson & Johnson’s Janssen subsidiary and Bayer Healthcare announced the findings of two Xarelto studies in a press release on September 1, indicating that the real-world date matched the results of clinical trials for Xarelto. One study was a post-marketing safety surveillance (PMSS) and the other was a study known as XANTUS which looked at stroke prevention rates).

While the clinical trials conducted before Xarelto was approved, known as ROCKET AF, found 3.6 major bleeding events occurred due to the side effects of Xarelto for every 100 person-years of use, PMSS found a rate of 2.89, while XANTUS indicated a rate of 2.1.

Real-world data was also presented by the makers of Eliquis, Bristol-Myers Squibb and Pfizer. Their findings indicate that patients suffered fewer bleeding events on Eliquis than they did with either Xarelto, the current industry leader, or the older warfarin; the blood thinner both drugs were designed to replace.

Eliquis had a rate of 2.68 major bleeding events, compared to the 3.6 observed for Xarelto in ROCKET AF, the study found. However, it did not take into consideration the lower numbers presented by its rivals at the same conference.

Xarelto and Eliquis Bleeding Concerns

Eliquis (apixaban) and Xarelto (rivaroxoaban) are part of a new class of anticoagulants introduced in recent years for prevention of strokes among individuals with atrial fibrillation. Pradaxa (dabigatran) was the first member of this class to hit the market in late 2010, followed by Xarelto in 2011 and Eliquis in 2012.

The medications are promoted as superior alternatives to Coumadin (warfarin), indicating that they are easier to use since patients do not require the same level of blood monitoring. However, concerns have emerged about the potential bleeding side effects associated with the medications, as none were introduced with an effective antidote that doctors can use to reverse the blood thinning effects of the medication if bleeding occurs.

Thousands of Pradaxa lawsuits, Xarelto lawsuits and Eliquis lawsuits have been filed in recent years, alleging that the drug makers failed to adequately warn about the bleeding risk and the lack of an effective reversal agent.

Following several years of litigation over Pradaxa, which was the first medication of the class to hit the market, Boehringer Ingelheim agreed to pay about $650 million in Pradaxa settlements in May 2014, with an average of about $150,000 awarded to former users who experienced bleeding side effects. However, additional cases continue to be filed by individuals who have suffered injuries since the date of the settlement.

There are currently more than 1,200 lawsuits pending throughout the federal court system over Xarelto bleeding injuries, which are currently centralized for pretrial proceedings as part of an MDL, or multidistrict litigation. Unless Xarelto settlements are reached to resolve the litigation, the first trials are expected to begin by August 2016.

In recent weeks, a growing number of claims have been filed by users of Eliquis, raising nearly identical allegations to those brought against the makers of Xarelto and Pradaxa, alleging that users may have avoided uncontrollable bleeding information if adequate warnings had been provided for users and the medical community.