Xarelto Internal Bleeding Dangers on the Rise
This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.
It appears yet another second-generation anticoagulant, Xarelto, is raising eyebrows over safety concerns. It has a dangerous side effect of internal bleeding.
Xarelto Internal Bleeding Timeline
Rivaroxaban is an oral anticoagulant invented and manufactured by Bayer. Janssen Pharmaceuticals markets rivaroxaban as Xarelto. In September 2008, Health Canada granted a marketing authorization. It was for rivaroxaban taken once daily for the prevention of venous thromboembolism (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery.
In September 2008, the European Commission granted marketing authorization of rivaroxaban for the same indication.
Then, in December 2011, rivaroxaban was approved by the European Commission for use in two new indications: prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors, and for the treatment of deep venous thromboembolism. It was also approved for prevention of recurrent deep venous thromboembolism and pulmonary embolism (PE) following an acute deep venous thromboembolism in adults.
On July 1, 2011, the U.S. Food and Drug Administration (FDA) approved rivaroxaban for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adults undergoing hip and knee replacement surgery. Then, on November 4, 2011, the U.S. FDA approved rivaroxaban for stroke prophylaxis in patients with non-valvular atrial fibrillation.
On November 2, 2012, the U.S. Food and Drug Administration (FDA) approved rivaroxaban for the treatment of patients with deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as long-term treatment to prevent recurrence. Then, on May 24, 2013, the European Commission gave its approval to rivaroxaban for secondary prevention in adult patients. These patients had a biomarker-confirmed acute coronary syndrome (ACS). The indication is for 2.5-mg twice-daily in combination with standard antiplatelet therapy.
Safety Concerns over Xarelto Internal Bleeding
In 2013, Bayer reported 968 side-effect reports tied to the anticoagulant Xarelto. This included 72 deaths. This was up from the 750 reports of adverse reactions and 58 deaths in all of 2012. Some doctors are also growing weary of using the drug as a standard first-line treatment.
In the US, when people experience side effects from a prescription or over-the-counter medicine, they or their doctors may report the events to the U.S. Food and Drug Administration (FDA). The agency records these events in the FDA Adverse Events Reporting System (AERS). A company called Adverse Events, Inc. has created special software that analyses the information in the AERS. Their analysis provides detailed information about side effects experienced by patients across America. There have been more than 2,100 total reports involving Xarelto. Plus, 1,821 reports listed the drug as the primary suspect for an adverse event.
Common Xarelto Side Effects
Of the more than 1,800 adverse events researchers linked to Xarelto, the most common events were a pulmonary embolism (386 reports), deep vein thrombosis (279 reports), gastrointestinal hemorrhage (107 reports) and hemorrhage (107 reports). Other adverse events reported included thrombosis, hemoglobin decrease, cerebrovascular accidents, hematoma, edema peripheral and dyspnea. The FDA said hospitalization occurred in 891 of these events; 183 patients lost their lives.
Recently, the FDA rejected Xarelto use for the treatment of acute coronary syndrome. The agency said the drug makers failed to show that the drug was both safe and effective. For the third time, the FDA refused to expand Xarelto’s approved use.
Therefore, if a doctor prescribed you or a loved with Xarelto and you suffered an internal bleed, please contact The Michael Brady Lynch Firm. We offer a free, no-obligation case evaluation.