Xarelto (generic name Rivorabaxin) is an oral anticoagulant prescription medication that is prescribed to reduce the risk or prevent additional cardiovascular events (such as a heart attack or stroke). It is also prescribed for people who have had a DVT (deep vein thrombosis) and/or PE (pulmonary embolism/blood clot in the lungs) or for people who are at risk for developing a DVT and/or PE.Who is responsible for Xarelto?
In 2015 alone, Xarelto took in nearly $2 billion in sales. The drug was developed and is manufactured by Bayer, although the German pharmaceutical company partnered with Janssen Pharmaceuticals, part of Johnson & Johnson, to market the drug in the U.S. The U.S. Food and Drug Administration (FDA) first approved Xarelto in 2011 to be used in patients recovering from knee and hip surgery. Not long after, the FDA also approved it for use in patients with atrial fibrillation, a type of abnormal heart rhythm, to avoid clot formation. Xarelto is Bayer’s best-selling drug and in 2016 contributed 2.9 billion euros ($3.41 billion) in revenues to the German group’s pharmaceutical business. J&J in 2016 reported $2.2 billion in revenues from Xarelto.What is the history of Xarelto's research and clinical trials?
There are very strong allegations being asserted against the drug companies, Bayer, Janssen and Johnson & Johnson. The allegations include a failure to disclose and make publicly available critical data found in the clinical trials. It is argued that this data revealed how risky Xarelto is, which in turn, led to accusations that Janssen and Bayer were hiding data to boost profits. The companies have been accused of leaving out data, failing to warn patients of the full risks of using the medication and of marketing Xarelto as a drug that is safe, while knowing it possessed serious health risks.
A clinical trial, called Rocket AF, took place from 2006 to 2010 and involved more than 14,000 patients. While reviewing the results of this trial, a reviewer for the New England Journal of Medicine asked the drug companies for the data from the clinical trial. It was later discovered that the reviewer was not given all the applicable data. Moreover, the researchers in the trial were using a recalled blood-reading device to take measurements, which calls into question all the data from the clinical trial.What are the Alleged Problems With Xarelto?
Xarelto became popular because it requires no blood testing and it comes as a convenient once-a-day pill. However, the allegations are that the drug can cause serious health problems including:
- irreversible internal bleeding that can lead to hospitalization, serious irreversible injuries or death;
- there is no antidote for Xarelto. Anyone with excessive bleeding while on the drug may not be able to stop the bleeding until the drug has left their body;
- If Xarelto is prematurely discontinued, it can lead to causing the very thing it is designed to prevent - a life-threatening blood clot;
- a patient taking Xarelto that simultaneously undergoes a procedure involving a spinal puncture, may become paralyzed.
- gastrointestinal hemorrhages make up the largest number of injury cases caused by Xarelto, followed by cerebral hemorrhages.
- a 2015 study published by The Journal of Arthroplasty, found that the use of Xarelto to prevent DVT after hip or knee replacement surgery led to significantly higher incidences of deep surgical site infections (SSIs) in patients. The study noted that such infections within the patients’ joints were “disastrous complications,” and that the use of Xarelto is directly linked to the increased risk of these wound infections, as well as SSI drainage (leakage).
On December 5, 2017, a Philadelphia state court jury ordered Bayer and Johnson & Johnson to pay $27.8 million to an Indiana couple over the drug makers’ failure to warn of internal bleeding risks from the blood thinner Xarelto. The couple's attorney said in a statement that “Xarelto is the worst in class of the new blood thinners. The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks.”
More than 20,000 lawsuits have been filed in state and federal courts as a result of patients suffering from bleeding, wound leaks and infections after taking Xarelto. More than 19,500 lawsuits have been consolidated under a MDL (multidistrict litigation) in the U.S. District Court for the Eastern District of Louisiana and more than 1,500 are pending in Philadelphia's Complex Litigation Center.
If you have used Xarelto or a family member was injured or died from bleeding or infections caused by Xarelto, you could have a strong case against the manufacturers.