If you suffer from atrial fibrillation (afib), worries over your medication, blood level testing and regular doctor visits can be a constant concern.
But even as new anticoagulant drugs such as Xarelto® enter the market with the promise of easing or even eliminating these worries, it’s important to note that a number of new blood thinner medications have been associated with several health concerns.
Xarelto (rivaroxaban) Side Effects
Xarelto (rivaroxaban) is a prescription anticoagulant, or blood thinner, used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (heart rhythm disorder), and is taken by more than 1.4 million people. Manufactured by Bayer and marketed by Janssen Pharmaceuticals, a Johnson & Johnson pharmaceutical company, Xarelto is also approved to help reduce the risk of and to treat blood clotting issues associated with deep vein thrombosis (DVT) and pulmonary embolism (PE).
People who take Xarelto may experience complications including:
Severe, uncontrolled bleeding requiring hospitalization
Xarelto History and Warnings
The Institute for Safe Medication Practices (ISMP), a nonprofit organization that tracks medication errors, reports more than 350 instances of serious, disabling or fatal injuries involving Xarelto. According to ISMP, direct reports submitted to the FDA by health professionals and consumers identified the Xarelto as the 10th “most frequent suspect drug in serious or fatal adverse events in 2012.”
The FDA initially approved Xarelto in July 2011 to reduce the risk of DVT or PE specifically following hip or knee replacement surgery. In November 2011, it was approved for treating patients with irregular heart rhythms (non-valvular atrial fibrillation) to reduce the risk of stroke. At this same time, the warnings were updated to include a boxed warning that “discontinuing Xarelto in patients with non-valvular atrial fibrillation increases the risk of stroke, and spinal/epidural hematoma.” A warning was also added indicating that an antidote for Xarelto is not available, putting patients at risk of severe bleeding.
A year later, after expedited review, FDA expanded the approved use of Xarelto to include the treatment and prevention of DVT or PE beyond hip or knee replacement surgeries.
Additional warnings were added to the Xarelto safety label in August 2013, indicating that stopping the use of Xarelto prematurely can increase the risk of thrombotic events, or blood clots. A warning was also added that Xarelto is not recommended for patients with prosthetic heart valves as the safety and efficacy of Xarelto has not been studied in that patient population.
Another warning was added to the Xarelto label in January 2014, including that the drug could increase the risk of an acute pulmonary embolism “in hemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.” Following this addition, an FDA committee denied the drug manufacturer’s request to add the treatment of recent acute coronary syndrome (ACS) to Xarelto’s list of primary uses due to lack of data from the drug’s original clinical trials, among other issues.
Another safety label addition in February 2014 included the study results of Xarelto along with multiple doses of the antibiotic erythromycin in patients with poorly functioning kidneys (renal insufficiency). The study suggested that patients with these conditions may have an increased risk of bleeding.