Xarelto is a popular blood thinner drug, which has generic name of rivaroxaban. It is prescribed to help prevent strokes in patients. It is a popular drug because patients are not required to have a blood test completed to determine dosage, unlike with warfarin, nor do they have to follow a special diet. The drug earned Bayer, its manufacturer, and Johnson & Johnson (J&J), its marketer, $1.3 billion in 2013 alone.

While both Bayer and J&J claim that Xarelto is both safe and convenient, there is actually a very serious side effect associated with it, which is internal bleeding. This risk exists with any type of blood thinner, but there is no antidote for Xarelto, which makes it even more dangerous. With other thinners, a course of vitamin K would stop the problem, but this is not the case with Xarelto.

Lawsuits Filed

Various lawsuits have been filed against Bayer by people who suffered severe bleeding, or by the surviving loved ones of those who actually had a fatal hemorrhage. The number of cases is mounting rapidly. As of October 15, 2015, 1,689 total cases have been filed against Bayer.

“The cases have been consolidated to form MDL No. 2592, and are being overseen by the Honorable Judge Eldon E. Fallon. Recent reports have noted that as of the 15th of October, 2015, the Xarelto MDL was made up of 1,689 cases in total. This number has significantly skyrocketed since July, and it is expected to continue to grow.”

Several days later, the number of cases surpassed 1,900 and it is believed that there will soon be more than 2,000 cases. The different cases cite different problems, but all are related to uncontrollable internal bleeding, including strokes. Survivors claim that they will need lifelong medical care in order to have any quality of life, and others have actually lost their lives due to the bleeding. All allege that Bayer is aware of these dangers and that they did not properly warn the public.

The Bayer Response

Despite the increasing number of cases against them, Bayer continues to declare that the drug is safe, basing this on two real-world studies.

“These findings show the use of rivaroxaban in day-to-day care is consistent with the safety profile observed in ROCKET AF, the landmark Phase 3 study used by regulatory authorities worldwide to approve the medicine for the prevention of stroke in patients with non-valvular atrial fibrillation.”

The first study was the PMSS (Post-Marketing Safety Surveillance), which is an ongoing five year study. After two years of continuous research, it was found that incidents of internal bleeding were very low, particularly fatal bleeding. The second study was the XANTUS (XARELTO for Prevention of Stroke in Patients with Atrial Fibrillation), which concluded the same: bleeds exist, but are rare and it is particularly uncommon for them to be fatal.

At the same time, however, the FDA has already raised significant concerns about the PMSS study, despite the fact that the FDA still approved the drug. The British Medical Journal, meanwhile, reported findings in their studies that were very different from those reported by Bayer.

“Although rates of gastrointestinal bleeding seem to be similar in this commercially insured sample of adults in the United States, we cannot rule out as much as a 50% increase in the risk of gastrointestinal bleeding with dabigatran compared with warfarin or a more than twofold higher risk of bleeding with rivaroxaban compared with warfarin.”

This demonstrates that there is severely conflicting evidence and research out there. While there is no way of saying which one of the two camps are correct, it is clear that people who have suffered as a result of Xarelto-induced internal bleeding feel the British Medical Journal’s report is more accurate and they are taking legal action in relation to this.

Meanwhile, J&J continues to market Xarelto and it is in the company’s interests to make sure it is marketed in a positive light. This is perhaps why the two studies cited by Bayer were funded and it is certainly why there now seems to be a strong focus on <a href=”https://www.portola.com/clinical-development/andexanet-alfa-prt4445-fxa-inhibitor-antidote/”>developing an antidote, known as Andexanet alfa.

“Potential first-in-class recombinant, modified Factor Xa molecule that is being developed as an antidote for patients receiving a Factor Xa inhibitor who suffer a major bleeding episode or who may require emergency surgery.”

The drug is currently being developed by Portola, which has the global commercial rights to the drug. The company is working together with other drug manufacturers, however, for whom Andexanet could possibly work as an antidote. One of those companies is Bayer. A proof-of-concept study is planned and it is hoped that drug will soon be commercially available.

It continues to be alleged, however, that both Bayer and J&J were aware of the dangers associated with taking Xarelto and that they failed to warn the public about this. For many, the reasons behind this are purely financial.

“There is plenty of incentive for Janssen and Bayer to present their product in the best possible light, despite the demonstrated dangers to patients. Worldwide, the number of elderly patients is increasing due to greater longevity. According to FiercePharma, the market for anticoagulants such as Xarelto is expected to grow faster than those of other medications over the next three years. Another report indicates that sales for anticoagulants could reach over $15 billion by 2018. By that time, Xarelto is expected to capture over 20% of that lucrative market.”