Experts have cautioned for years that new-generation oral blood thinners like Xarelto may have similar internal bleeding risks as warfarin, the traditional drug they were designed to replace.
And, recent studies show the risks for gastro-intestinal bleeding in particular may even be higher with Xarelto than warfarin.
Now, a new study out of Duke University provides a possible explanation for the added bleeding risks of drugs like Xarelto and Pradaxa. Researchers found that internal bleeding incidents rose as patients increased the number of medications taken around the same time.
Results Based on 2011 Clinical Trial
The study, published in the December American Heart Association Journal Circulation, re-examined data from the initial ROCKET AF clinical trial conducted on over 14,000 patients taking either Xarelto or warfarin, which was published in September 2011.
That study originally showed that Xarelto was no worse at preventing strokes in patients with atrial fibrillation, and had bleeding rates that weren’t notably higher.
However, the first re-examination of this data last fall revealed that, while Xarelto patients may not have higher overall rates of serious internal bleeding, they did in fact have higher rates of gastrointestinal bleeding.
Higher Average A-Fib Patient Medication Intake
Now, researchers have taken another look at the ROCKET AF data and found that patients taking either warfarin or Xarelto are also often taking several other meds at the same time.
Specifically, 36% of the study patients were taking up to four medications together; 51% were taking between five and nine medications; and 13% were taking 10 or more medications at the same time.
That means almost two-thirds of patients were taking five or more mediations together.
Bleeding Risks Increased With Highest Drug Multiplicity
The practice of polypharmacy, or taking more than four prescription drugs at once, was not linked to a greater risk of stroke among atrial fibrillation patients.
However, researchers found that, among the group of patients taking ten or more drugs at once, the risk of internal bleeding was nearly 50% higher.
Rising Lawsuits and FDA Reports of Xarelto Bleeding
To date, the FDA has received over 7,600 Adverse Event reports of patients suffering internal bleeding complications while taking Xarelto, along with 880 reports of patient death.
While many reports point to the fact that Xarelto does not have an antidote to stop bleeding in emergencies as does warfarin, this current data indicates the manufacturer should also consider adding label warnings against taking the drug with multiple other medications.
Due to the rise in patient bleeding and death reports, the Judicial Panel on Multidistrict Litigation has created a special federal court to expedite lawsuits against the manufacturers, Bayer and Johnson & Johnson.
So far, 2,892 Xarelto lawsuits have been filed in or transferred to this MDL court, with lawyers anticipating many more. Similar bleeding litigation against rival drug Pradaxa in 2014 resulted in more than $650 million in awards to injured patients.
For more information on the recent research regarding Xarelto bleeding, or to speak directly with a lawyer about the pending litigation for patients, contact us today.
Piccini, J. M.D. Polypharmacy and the Efficacy and Safety of Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation. AHA Circulation. (December 16, 2015). Retrieved from www.circ.ahajournals.org
Brauser, D. Less Bleeding on Rivaroxaban for AF if Fewer Concomitant Meds. MedScape. (January 11, 2016). Retrieved from www.medscape.com
Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.
The FDA enacted tough new regulations this week aimed at making sure all women who are considering implantation of the Essure birth control device fully understand all the risks and benefits before moving forward.