Xarelto Side Effects Linked to Reports of Problems, Deaths: Report

A new report suggests that side effects of Xarelto, which is a relatively new anticoagulant that is part of the same class of medications as the controversial drug Pradaxa, may be responsible for dozens of patient deaths and hundreds of adverse event reports.

The German newspaper Der Speigel (in German) indicates that at least 968 adverse events involving Xarelto were reported to German health officials in the first eight months of 2013, including 72 deaths.

The numbers compare to 750 adverse event reports and 58 deaths throughout all of last year, indicating that the the increase tracks with the rise in use of Xarelto, which has reportedly increased 240% after just a year and a half on the market.

Xarelto (rivaroxaban) is one of a new generation of anticoagulants used to reduce the risk of blood clots and strokes. Known as “direct thrombin inhibitors,” the new class of medications are marketed as a replacement for Coumadin, or warfarin, which has long been the standard anticoagulation therapy. The new class of treatments have been promoted as superior to warfarin because they are easier to take and require less frequent monitoring to maintain the correct dose.

Pradaxa (dabigatran) is another medication in the same class, and has become the most widely used after Boehringer Ingelheim was able to gain the market advantage of being the first to market. However, as adoption of these new anticoagulants increases, concerns have surfaced about the risk of serious and potentially life-threatening problems, including the risk of uncontrollable bleeding from Pradaxa and Xarelto.

While all blood thinners carry a risk of bleeding, Xarelto, Pradaxa and other direct thrombin inhibitors currently lack an effective reversal agent. While doctors are able to administer a dose of vitamin K and plasma to reverse any bleeding problems that develop with warfarin, no such antidote is available for the new class of medication, making it harder to prevent serious injury or death if patients suffer bleeding problems.

Concerns about the safety of Pradaxa began to surface shortly after the medication was introduced in October 2010, as it quickly became one of the drugs most commonly associated with adverse event reports submitted to the FDA.

During 2011, the first full year the drug was on the market, the Institute for Safe Medication Practices (ISMP) found that adverse event reports involving Pradaxa problems surpassed all other medications regularly monitored by the group. The FDA received at least 3,781 reports involving serious injuries associated with the use of Pradaxa during 2011, including 2,367 reports of hemorrhage and 542 patient deaths.

Boehringer Ingelheim currently faces hundreds of Pradaxa bleeding lawsuits that have been filed on behalf of former users of the medication who allege that the drug maker failed to adequately warn about the risk uncontrollable bleeding or the lack of an available reversal agent to stop bleeding problems that may develop.

Bayer and Johnson & Johnson are working with a company called Portola Pharmaceuticals to try and develop a Xarelto reversal agent and are testing one possible antidote. Boehringer Ingelheim is also reportedly looking for a reversal agent for Pradaxa.

Officials at Bayer say that despite the growing adverse event reports, the benefits of Xarelto outweigh the risks and they and Johnson & Johnson are trying to spread the drug to even more patients by investigating its potential use to treat patients suffering from heart failure and coronary artery disease. The drug generated $425 million in sales last year and has nearly reached the half billion mark already this year.