Commonly Asked Questions About Xarelto
WHEN TAKING XARELTO, IS SERIOUS BLEEDING A RISK PATIENTS NEED TO PAY ATTENTION TO?
Like most blood thinners, rivaroxaban can cause unchecked hemorrhaging in patients. This is because the medication decreases the viscosity of cardiovascular fluid, so it can more easily escape through any damaged vessels. When hemorrhaging occurs close to an organ, it can quickly damage the organ and possibly result in organ failure. When serious health complications result from taking rivaroxaban, it is usually because of organ hemorrhaging.
EVEN THOUGH RESEARCHERS HAVE NOTED A XARELTO BLEEDING RISK, ARE DOCTORS STILL PRESCRIBING THE DRUG?
Rivaroxaban is manufactured by Johnson & Johnson and is one of the newer blood thinners available. It is considered an alternative to warfarin, another blood thinner that has been in use for nearly 50 years. Initially, rivaroxaban was approved by the Food and Drug Administration (FDA) for use in patients who had recently received hip or knee replacement surgery. Soon after its initial approval, the drug was also recommended for use in patients suffering from irregular heartbeat. In these patients, rivaroxaban can prevent clotting, a recurring issue in people with atrial fibrillation. There is some controversy regarding the FDA’s approval of rivaroxaban for additional patients, as more research is required to determine how safe it is.
Even though lawsuits are currently being filed against Johnson & Johnson, no recall has been announced. As of September 2014, only labeling changes have been proposed to alert patients and medical professionals to the medication’s dangers.
WHAT IS THE CURRENT RESEARCH REGARDING XARELTO AND ITS BLEEDING RISK?
Several studies have been organized to determine rivaroxaban’s efficacy and its side effect profile. Perhaps most alarming is a study published by the New England Journal of Medicine in 2011. This study found that rivaroxaban was no more effective than warfarin in protecting people from cardiovascular problems. The study also found that rivaroxaban was more likely to cause abdominal hemorrhaging.
In 2009, a Phase III study performed on rivaroxaban found that of the 16,000 participants who were given the drug, near 75 percent suffered from some side effects. Participants who took higher doses of rivaroxaban or took it longer were more likely to suffer from serious side effects like hemorrhaging.
In addition to hemorrhaging, these side effects include altered heartbeat, altered blood pressure, edema, gastrointestinal hemorrhaging, nausea, vomiting and dizziness. Researchers have also noted an increased danger of clotting if the medication is discontinued suddenly.
HAVE LAWSUITS BEEN FILED AGAINST THE DRUG’S MANUFACTURER?
Lawsuits are starting to become an issue for Johnson & Johnson, as many people are filing claims against the company due to complications associated with rivaroxaban. A slightly older but comparable drug, Pradaxa, has been plagued with thousands of lawsuits, prompting its maker, Boehringer Ingelheim to settle on more than 4,000 claims totaling roughly $650 million.