A recent study asserts that doctors are not following safety guidelines when prescribing anticoagulant medications like Xarelto and Eliquis. Both of these drugs are the subject of personal injury lawsuits that have been filed around the country.
The study was published June 19, 2017, in the British Journal of General Practice. Researchers examined data from 645 general practices contributing to the Health Improvement Network, a large U.K. database of primary care records.
Doctors Ignoring Contraindications for Anticoagulant Drugs
Anticoagulant medications like Xarelto and Eliquis have been found to increase the risk of excessive bleeding. But some people are at a higher risk than others because of their age, nationality, or other health conditions. This new study suggests that doctors may be ignoring at risk populations when prescribing these drugs.
Researchers identified patients who had been diagnosed with atrial fibrillation (AF—one of the conditions these drugs are FDA-approved to treat), and who were 35 years of age or older. They also identified which patients were prescribed anticoagulant medications, and which had contraindications for those medications—any medical condition or other factor that renders a particular line of treatment improper or undesirable.
Results showed that over a period of 12 years, between 2004 and 2015, the proportion of patients with contraindications who were still prescribed these drugs increased from 40.1 percent to 67.2 percent. (Prescriptions to those without contraindications also increased from 42.1 percent to 67.7 percent.)
Further, for patients who had a recent major bleeding event, prescribing rates in 2015 increased from 44.3 percent in 2004 to 71.1 percent. In those who had suffered an aneurysm, the rates increased from 44.3 percent to 63.2 percent.
The researchers concluded that doctors are not paying close enough attention to these other factors that can significantly increase a patient’s risk of bleeding. They are giving drugs like Xarelto and Eliquis, which already carry a risk of excessive bleeding, to patients who are already at an increased risk for bleeding, compounding the danger.
The researchers reported that “[t]he presence or absence of recorded contraindications has little influence on the decision to prescribe anticoagulants for the prevention of stroke in patients with AF”. “The study analysis suggests that nationally, 38,000 patients with AF with contraindications are treated with anticoagulants” and issue which the researchers noted “has implications for patient safety.”
Xarelto Leads the Pack in Reports of Injuries and Deaths
Meanwhile, more than 18,000 Xarelto lawsuits are pending against the manufacturers of the drug. These lawsuits are filed by individuals who took the drugs and then claimed to have suffered excessive bleeding. All federally filed cases have been centralized in the Eastern District of Louisiana, where bellwether trials are currently underway.
Plaintiffs claim that the defendants failed to provide adequate warnings about the drug’s risks. While another issue raised in these cases is that Xarelto had no readily available antidote. Patients taking warfarin, the leading anticoagulant for decades, can receive injections of vitamin K to help stop the bleeding. Patients taking Xarelto, however, must simply wait for the drug to clear from their systems, which can greatly increase the risk of complications and even death.
The QuarterWatch publication released on July 12, 2017, by the Institute for Safe Medicine Practices (ISMP) stated that oral anticoagulant risks of side effects are “unacceptably high” and noted that Xarelto led the pack by accounting for 21,996 reports of severe injuries in the U.S., including 3.018 reported deaths.