In July, the Institute for Safe Medication Practices (ISMP) published findings from its analysis of the adverse drug events reported in the U.S. throughout the 2016 calendar year. The group looked at data from the U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS), which includes reports of negative side effects of prescription and over-the-counter drugs. Oral anticoagulants or blood thinners, specifically Xarelto, lead the way in terms of risks for serious adverse events.
There were 21,996 severe injuries reported involving anticoagulant drugs including 3,018 reported deaths, and Xarelto was the top culprit for this class of drugs. The ISMP reports that “practically all these injuries…were from hemorrhages, making bleeding one of the most frequently reported serious adverse drug effects of all types.”
The Centers for Disease Control and Prevention (CDC) echoed these findings in its own Medication Safety Program’s Adverse Event Monitoring report. It found that for older adults, blood thinners such as Xarelto, “accounted for more emergency department (ED) visits for outpatient adverse effects than any other class of drugs,” placing it ahead of diabetes drugs and opioids (non-abuse visits).
Beasley Allen has previously explained that the U.S. Judicial Panel on Multidistrict Litigation (JPML) established a Xarelto multidistrict litigation (MDL), which is centralized in the United States District Court for the Eastern District for Louisiana. The JPML reports there are currently 17,593 actions pending as part of the MDL.
The lawsuits have been filed against Xarelto’s makers, German drug manufacturer Bayer AG and Johnson and Johnson’s Janssen Pharmaceuticals. Plaintiffs claim the companies designed a defective drug when they failed to develop a way to monitor its effect on patients – limiting doctors’ ability to measure a patient’s risk of bleeding and initiate life-saving measures in a timely manner.
The FDA initially approved Xarelto in July 2011 to prevent blood clots following orthopedic surgery and to prevent strokes for patients with atrial fibrillation. The agency expanded its approval in 2012 to treat deep vein thrombosis and pulmonary embolism.
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Lawyers in Beasley Allen’s Mass Torts Section continue to investigate injuries suffered by patients who took Xarelto. Injuries include gastrointestinal, rectal and brain bleeds, and deaths caused by major bleeding events. If you would like more information, contact Joseph VanZandt, a lawyer in the Mass Torts Section. You can reach him at 800-898-2034 or by email at Joseph.Vanzandt@beasleyallen.com.
Institute for Safe Medication Practices
Centers for Disease Control and Prevention
U.S. Judicial Panel on Multidistrict Litigation