Anticoagulants Reported to Have the Most Dangerous Side Effects
Reports say that there are already a number of adverse events that have been included in the U.S. Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) regarding Xarelto. Hemorrhage or abnormal bleeding is one of the most common dangerous side effects reported in FAERS with Xarelto as the primary suspect drug. Signs and symptoms of Xarelto-induced internal bleeding may vary, depending on the location of the bleeding, and what body functions are affected. Of the thousands adverse events linked to Xarelto, the most common events include pulmonary embolism (PE), deep vein thrombosis (DVT), gastrointestinal hemorrhage and hemorrhage. Other negative side effects linked with Xarelto as reported in the FAERS include thrombosis (blood clots); cerebrovascular accidents (an event that leads to a stroke, such as a cerebral hemorrhage); decreased hemoglobin (a substance that carries oxygen in red blood cells); ); peripheral edema (swelling of the lower limbs); hematoma (a semisolid mass in the bloodand dyspnea (difficulty breathing). In 2013, the German newspaper Der Speigel reported that 968 adverse events including 72 deaths involving Xarelto were reported to German health officials. This is on top of the 750 adverse events and 58 deaths in 2012. Xarelto was introduced to the market in July 2011 by Janssen Pharmaceuticals, a Johnson & Johnson (J&J) company. It is co-marketed by Bayer. The safety and effectiveness of Xarelto has been questioned because of the several complaints from patients. In fact, some of them have already filed lawsuits against the manufacturer. On January 9, 2012, the Reuters reported that that Britain’s National Institute for Health and Clinical (NICE) is asking Bayer to provide more safety data before it can recommend the drug for use in the state health services. Experts are also looking into Xarelto’s possibility to cause paralysis among patients who have been injected with Neuraxial Anesthesia. According to the FDA, they are now in the process of evaluating the reported adverse side effects experience by patients being treated with Xarelto. The agency aims to know if the risks outweigh the benefits of the drug.
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The Institute for Safe Medication Practices (ISMP) revealed that anticoagulants, including Xarelto (rivaroxaban), were the most dangerous drugs with the highest number of serious side effects reported to the U.S. Food and Drug Administration (FDA).
