Xarelto is an anti-coagulant several major side effects the most serious of which is internal bleeding because it can quickly lead to death. Those that have experienced internal bleeding due to Xarelto have filed lawsuits against Bayer claiming the company knew about the severe risks involved and was negligent in warning the public.
Xarelto is prescribed as a blood thinner to reduce the risk of blood clots that may lead to strokes. Xarelto is a popular choice among doctors and patients because it does not require the strict diet changes or frequent blood tests to determine accurate dosage the way Warfarin and other older anti-coagulants do. Xarelto, which made $1.3 billion in sales in 2013, is manufactured by Bayer and marketed by Johnson & Johnson. When advertised, Xarelto claimed to be safer and more convenient than Warfarin, however the dangerous side effect of internal bleeding was not revealed in the warning.
In 2013, it was reported that the number of deaths caused by Xarelto rose from 2012.
All anticoagulants are associated with a risk of internal haemorrhaging caused by their action. However, the effects of older medicines such as Warfarin can be reversed with emergency procedures. Unfortunately, there’s no antidote for Xarelto. Without a reversal agent, doctors can’t do much to stop the bleeding except dialysis to the remove the drug from the patient’s body. In many instances, however, rivaroxaban was not removed from the blood through dialysis leading to lethal injuries.
How Does Xarelto Cause Bleeding?
Xarelto is designed to stop blood from clotting; it works by blocking the production of certain proteins that normally start the process of blood clotting. With nothing to stop the blood any injury, even minor ones, can be life threatening. Xarelto was manufactured without an antidote therefore when bleeding occurs there is no way to stop it. The only option is dialysis to cleanse the body of the drug. However, it can take up to 24 hours for Xarelto to be eliminated from the body and therefore dialysis may not inhibit the bleeding. The older the patient, the more difficult it is to eliminate the drug. Seniors are at an increased risk for fatal bleeds. As severe bleeding continues to be present in emergency rooms doctors are growing less and less fond of prescribing the drug.Patients who are undergoing surgery must stop taking Xarelto at least 24 hours prior to the procedure to prevent complications. When compared with Warfarin, Xarelto is known to causes more abdominal bleeding.
Black Box Warning For Spinal Bleeding
The FDA has released a severe warning for spinal bleeding in regards to Xarelto. Spinal bleeding or Hematomas are pools of blood that occur in the spine which can lead to permanent paralysis. People are at greater risk if they:
• Use epidural catheters
• Use other drugs that can affect the clotting process, such as NSAIDs or platelet inhibitors
• Have a history of spinal trauma
• Have a history of spinal surgery
Internal Bleeding Xarelto Lawsuits
In February 2013, Stuntebeck was hospitalized with severe gastrointestinal bleeding due to this drug. In the lawsuit, Stuntebeck claims that Bayer did not appropriately warn the public about the life-threatening risks associated with the drug and that it never should have been sold.
“As the manufacturers and distributors of Xarelto, defendants knew or should have known that Xarelto use was associated with irreversible bleeds,” the complaint reads.
An older anti-coagulation drug, Pradaxa, also caused irreversible bleeding and many lawsuits were filed. The manufacturer of Pradaxa, Boehringer Ingelheim, paid $650 million to settle 4,000 cases.
In spite of the overwhelming evidence that Xarelto is responsible for severe internal bleeding, Bayer continues to state that the drug is safe.
- Patel MR, Mahaffey KW, Garg J, et al; and the ROCKET AF Steering Committee, for the ROCKET AF Investigators. “Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.” N Engl J Med. 2011;365(10):883-891.
- Institute for Safe Medication Practices (ISMP) “QuarterWatch Monitoring FDA MedWatch Reports – Anticoagulants the Leading Reported Drug Risk in 2011 – May 31, 2012 – New Data from 2011 Quarters 3 – 4”