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Federal researchers warn that one out of every 250 Americans may end up in the emergency room due to drug side effects, with many older Americans suffering serious bleeding events from Xarelto, Pradaxa, and other blood thinners.
In a report published this week by the U.S. Centers for Disease Control and Prevention (CDC) in the Journal of the American Medical Association (JAMA), researchers indicate that high rates of serious adverse events potentially caused by drugs have hospitalized many Americans in recent years, with antibiotics, blood thinners, diabetes drugs, and powerful pain killers and antipsychotics being responsible for the vast majority.
The study sought to determine the characteristics of adverse drug events that resulted in U.S. patients ending up in the emergency room. It used data from 58 emergency departments across the country which participated in the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project from 2013 and 2014.
According to the findings, four out of every 1,000 emergency room visits in 2013 and 2014 were due to adverse drug events. About 27% of those resulted in hospitalization, with the highest hospitalization rates among adults over age 65 and older.
Antibiotics were the most common cause of adverse events among children and teens, followed by antipsychotics. Among adults ages 65 and older, blood thinners, diabetes drugs and opioids accounted for 60% of their adverse events.
The study specifically identified Xarelto, Pradaxa, warfarin and eonxaparin, a type of heparin, as drugs associated with many of the adverse events affecting older Americans. The study also indicated that insulin and a number of orally-taken diabetes drugs also ranked high.
Blood Thinner Risks
Xarelto and Pradaxa are both new-generation drugs introduced in recent years as alternatives to warfarin, which has been the go-to anticoagulation treatment among individuals with atrial fibrillation for decades.
While these newer medications are marketed as easier to use, concerns have emerged about the potential side effects of Xarelto and Pradaxa as many individuals have reported suffering problems with uncontrollable bleeding.
Unlike warfarin, where the blood thinning effects of the drug can be reversed quickly with vitamin K and fresh frozen plasma if bleeding problems develop, no safe and effective antidote has been approved for use with Xarelto and one has only been recently been approved for Pradaxa.
As a result of the drug makers’ failure to adequately warn about the bleeding risk, or disclose that reversal agents were not available, thousands of Xarelto lawsuits and Pradaxa lawsuits have been filed by individuals nationwide in recent years.
In 2014, following several years of litigation, Boehringer Ingelheim agreed to pay $650 million in Pradaxa settlements to resolve claims over severe injuries and deaths linked to their anticoagulant.
Given the more widespread use of Xarelto, there are already more than 10,000 cases pending nationwide involving this competing blood thinner, and the litigation is expected to continue to grow over the coming months and years, as the manufacturers defend the cases in court.
The CDC researchers said that knowing which drugs cause the most serious adverse events can help make drugs safer.
“The Patient Protection and Affordable Care Act of 2010 brought attention to adverse drug events in national patient safety efforts,” the researchers said. “Updated, detailed, nationally representative data describing adverse drug events can help focus these efforts.”