Untreated deep vein thrombosis (blood clot in the leg) can result in a pulmonary embolism when the blood clot in the leg breaks off and travels in the venous system to the lung.
All anticoagulants have a narrow therapeutic index; too little blood thinning and the patient has injury from strokes or embolism, too much and the patient develops bleeding and can even die.
New Drug Xarelto (Rivaroxaban)
Until recently there was only one option for an oral anticoagulant, Coumadin also known as Warfarin. Coumadin has been around for 60 years although not perfect, it was the best that we had. The problem with Coumadin was the need for frequent regular blood tests to measure the amount of blood thinning and avoidance of certain foods. We know it reduces the risk of strokes and pulmonary embolism and if the blood was too thin we could reverse it with vitamin K and blood products.
Recently new anticoagulation drugs have been approved for sale, the first being Pradaxa, followed by Xarelto and most recently Elquis. These medications act on a different blood thinning pathway to Coumadin and are known as direct Factor Xa (ten) inhibitors or thrombin inhibitors. Doctors prescribe Bayer’s billion-dollar blood thinner Xarelto to prevent blood clots and protect patients from strokes, deep vein thrombosis and pulmonary embolism. Xarelto may cause irreversible internal bleeding that can lead to hospitalization and death.
Institute of Safe Medication Practices Report
According to an industry consumer watchdog, the Institute of Safe Medication Practices (ISMP), noted that the number of serious adverse events with Xarelto bleeding side-effects is significant and worse that for another new blood thinner, Pradaxa. Xarelto prescriptions increased to nearly 1 million prescriptions per quarter, according to ISMP. ISMP monitors and analyzes serious adverse drug events reported to the U.S. Food & Drug Administration (FDA).
Xarelto Increasd Adverse Reports
As the usage of Xarelto increases in the United States, many Xarelto uncontrollable bleeding lawsuits are being filed against Bayer AG, and Johnson and Johnson, the manufacturers and distributors of Xarelto. In the first quarter of 2013, ISMP found 680 serious adverse event reports associated with Xarelto, compared to 528 complaints for Pradaxa. According to ISMP the trend is mostly due to doctors changing prescriptions for their patients from Pradaxa to Xarelto.
Xarelto and Pradaxa: No Antidote
Warfarin, the traditional go to blodd thinner drug, was approved by the FDA in 1954 and marketed under the brand names of Coumadin. There is no approved antidote for oral anticoagulants, such as Xarelto and Pradaxa. If significant bleeding should occur in patients taking the blood thinners then this lack of an antidote means that patients who suffer seemingly minor injuries are at risk of uncontrolled bleeding that could be fatal.
Xarelto is a Bayer drug that is marketed in the US by Johnson & Johnson and its subsidiary, Janssen Ortho LLC. Xarelto was initially approved by the FDA in July 2011 to reduce deep vein thrombosis and pulmonary embolism in patients who had knee or hip replacement surgery (preventive use). Xarelto use was expanded in November 2011 to reduce stroke and blood clot risks in patients with atrial fibrillation. Xarelto received FDA approval again in November 2013 to treat deep vein thrombosis and pulmonary embolism.
Hundreds of adverse event reports have been submitted to the FDA suggesting a link between Xarelto and bleeding injuries or death. Similar allegations have been raised in lawsuits, that the drug makers failed to adequately warn about the bleeding risk or lack of an effective Xarelto reversal agent. Xarelto was heavily marketed as superior to warfarin because it is easier to take and require no monitoring to maintain the correct dosage.