Xarelto is a blood thinning drug that is heavily advertised on television. Xarelto is promoted as an alternative to Coumadin and Warfarin. The side effects and dangers of Xarelto are much greater than are disclosed by Janssen Pharmaceutical, the manufacturer. Xarelto can cause uncontrolled bleeding for which there is no antidote. Xarelto patients have reported an unusually high incidence of blood clots including strokes, deep vein thrombosis, and pulmonary embolism.
Almost two dozen lawsuits have been filed in federal court by Xarelto users who had bleeding complications. These lawsuits were coordinated together in December 2014. So far, Xarelto has not been recalled by the FDA and there have been no lawsuit settlements or jury trials. Our firm is reviewing Xarelto claims and we are happy to discuss any adverse Xarelto events. Xarelto patients should not discontinue taking this drug without close consultation with their doctor.
Currently in the national litigation over Xarelto there are now over 5,600 individual lawsuits pending in multi-district litigation. The suits have been filed against pharmaceutical giants Bayer Corporation and Johnson & Johnson and focus primarily on the lack of a reversal treatment for Xarelto.
Xarelto (also known as rivaroxaban), was approved by the FDA in 2011 as a part of a new class of blood thinners prescribed to patients. The drug was seen as an alternative to warfarin (also known as Coumadin), which had been in use for over 60 years. This class of drug is prescribed to patients with atrial fibrillation to prevent strokes and to surgical patients to prevent post-operative blood clots in their legs and lungs.
Coumadin was effective, but often proved difficult to monitor dosages because it was directly affected by diet. Specifically vitamin K, found in leafy green vegetables, which if consumed could negate the drugs usefulness. The irony here being that Vitamin K could also be used to reverse Coumadin’s effect in case of emergency.
There is no reversal treatment for Xarelto and patients who take the drug and are unable to properly process it can be at risk of life threatening and uncontrolled bleeding. In spite of the risk More than 13 million Xarelto prescriptions have been written in the U.S., making it the most prescribed blood thinner in its class in the country.
The FDA approval of Xarelto in 2011 was not without controversy. Internal reviewers at the organization were concerned about the validity of the single study used as the basis for the drug’s approval. Documents uncovered in the current MDL seem to indicate that the reviewer’s concerns might be well founded.
To gain approval for Xarelto, Bayer and Johnson & Johnson hired the Duke Clinical Research Institute to run a three-year clinical trial that involved more than 14,000 patients. According to The New York Times, the trial compared the number of strokes and bleeding events experienced by patients taking Xarelto with those of patients using warfarin. The concern is that the faulty results may have led doctors to give patients the wrong dose of Coumadin, which could have favored Xarelto. But those results come under scrutiny since September, when the companies notified regulators that a blood-testing device used in the study had malfunctioned.
This has raised claims that Bayer and J&J used their influence to conceal clinical data in earlier journal articles in efforts to gain FDA approval for the drug. Both companies have contended they knew nothing of the faulty test results until 2015. This has prompted the FDA to revisit assessment of critical safety issues with regards to Xarelto. There has also been concern that the defective device used in the 2011 trial calls the validity of the results into question. Many prominent doctors are calling for an- independent study to reassess the drugs safety.
An aggressive timetable has been set for the MDL and any patients with questions regarding the safety of Xarelto should be urged to contact their physicians.
At Saunders & Walker we have a long history representing victims harmed by drugs and medical devices. We continue to offer representation to anyone suspecting that they, or their relatives, may have been killed or injured by dangerous medical products.