Since 2011 when the U.S. Food and Drug Administration (FDA) first approved the use of Xarelto to treat blood clots, the drug has been prescribed more than 44 million times in the United States alone. The medication is commonly used to help prevent blood clots in patients with atrial fibrillation (AF) and for people who have had surgery for a knee or hip replacement. When lawsuits were first filed about five years ago, Janssen Pharmaceutica (a subsidiary of Johnson & Johnson) closely reviewed its labeling information and decided that it clearly communicated Xarelto’s benefits, according to company spokesperson Sarah Freeman. Although both Johnson & Johnson and Bayer refute claims that the medication did not provide adequate notice about potentially fatal bleeding risks, the companies decided that settling the claims would be the best course of action in terms of time, resources, and ultimately providing care for patients. “As a healthcare company, we want to spend every moment we can improving lives and finding new cures,” says Freeman. “We stand behind Xarelto and are eager and excited to move forward. We continue to support studies that are exploring the potential of Xarelto to treat new areas of unmet medical need. And we remain committed to the millions of patients worldwide who have been prescribed the medication.” Because the pharmaceutical companies had won six other similar cases that went to trial, some have questioned why they did not challenge these lawsuits in court. Janssen has explained that these allegations have required their scientists to spend numerous hours answering questions, pulling them away from their research work, so it was in their best interest to put an end to these legal challenges.

News coverage of the litigation and plaintiffs’ lawyers soliciting clients through advertisements that warn of Xarelto’s potential side effects reportedly led many patients to stop using their prescribed anticoagulant drugs, according to Freeman. This may have resulted in serious health outcomes for some individuals. “As soon as I started seeing those lawyer commercials on TV about Xarelto, I wanted to call them up and say, ‘Now you have scared my patients about taking these drugs that are lifesaving to them,’” says Laurence M. Epstein, MD, system director of electrophysiology at Northwell Health in Manhasset, New York. “We know that there is a risk of bleeding from these blood thinners but the risk of having a stroke is far higher. This is just doing a disservice to patients. This is so upsetting to me.” Freeman adds, “Patients should not discontinue taking their medication without talking to their physician. That is first and foremost the most important thing for anyone taking Xarelto.” For the lawyers representing the patients who allegedly suffered injuries, such as internal bleeding, because of the medication, the settlement was fair. “Litigation like this is an important way for consumers to have a voice in matters of drug safety,” says Brian Barr, of the Levin Papantonio law firm in Pensacola, Florida, and co-lead counsel of the Plaintiffs’ Steering Committee for multidistrict litigation, in a statement.

Benefits Outweigh the Risks

The lawsuits also claimed that the manufacturers aggressively marketed the drug as an alternative for warfarin (Coumadin and Jantoven), which has been used for decades to help prevent blood clots. In the last several years, the FDA has approved new oral anticoagulant drugs — Xarelto (rivaroxaban), Pradaxa (dabigatran), Eliquis (apixaban), and Savaysa (edoxaban). The FDA has concluded that these drugs are either equal to, or more effective than, warfarin in preventing strokes, with an acceptable risk of bleeding. If significant bleeding occurs while taking warfarin, there is a reversal agent: vitamin K. An antidote for Pradaxa called Praxbind (idarucizumab) was introduced in 2015, and according to an article published in June 2018 in the journal Drugs, in May of 2018 the FDA approved AndexXa (andexanet alfa), the first and only antidote to reverse bleeding in people taking Xarelto, Eliquis, or Savaysa. “It is important to understand, however, that most of the bleeding associated with anticoagulants is not life-threatening; in fact, fatal bleeding is quite rare,” writes cardiologist Ellis Unger, MD, in an article published October 2015 on the FDA website. “We have concluded for all of the anticoagulants used in atrial fibrillation that the benefit of preventing strokes outweighs the increased risk of bleeding.” Dr. Epstein says, “I prescribe Xarelto every day and in fact, I take them off Coumadin to put them on these drugs.”

Research Continues to Improve Treatment

Atrial fibrillation (AF) is the most common heart rhythm problem in the United States, and it is projected to affect more than 12 million Americans by 2030, according to an article published in June 2018 in the Journal of the American College of Cardiology. Among patients hospitalized with acute ischemic stroke between 2003 and 2014, the prevalence of AF increased from 16 to 20 percent. AF heightens the risk for stroke because blood may not properly pump out of the heart, which can cause it to pool and form a clot. Janssen continues to perform research to investigate and potentially improve the effectiveness of Xarelto. According to a press release, a study presented at the 2019 American College of Cardiology’s Scientific Session found that newly diagnosed patients with nonvalvular atrial fibrillation taking Xarelto experienced significantly fewer strokes, significantly fewer severe strokes, and fewer stroke-related deaths compared with those taking warfarin. However, other research, published in September 2018 in The New England Journal of Medicine, revealed that Xarelto did not significantly lower risk of symptomatic venous thromboembolism, a condition in which a blood clot forms most often in the deep veins of the leg, groin, or arm. Xarelto has also been making headlines as Johnson & Johnson has begun running television ads announcing the drug’s cost in an effort to be transparent about pricing. According to an article published March 29, 2019, by Axios, the commercials, which began at the end of March, show the Xarelto list price as $448 per month but the actual patient payout is between $0 and $47, depending on insurance coverage.