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NSAIDs Increase Bleeding Risk with Xarelto—Study

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Patients who take Xarelto at the same time as pain relievers like Motrin, Aleve, and Advil, could be facing an increased risk of excessive bleeding side effects, according to a recent study.

Xarelto (rivaroxaban), which is a blood thinner prescribed after knee and hip replacement surgery and for those with non-valvular atrial fibrillation, can cause excessive bleeding on its own. A number of patients have already filed personal injury lawsuits against manufacturers Bayer and Janssen Pharmaceuticals because, according to their complaints, the companies failed to provide adequate warnings about the risks.

Results of this study, however, suggest that the risks can be compounded when Xarelto and other similar blood thinning drugs like Pradaxa and warfarin are taken together with non-steroidal anti-inflammatory drugs (NSAIDs).

Study Shows Increased Risk of Bleeding with NSAIDs

For the study, published in the Annals of Internal Medicine, Danish researchers looked at data from over 150,000 patients with atrial fibrillation who were prescribed an NSAID during a follow-up period of about six years. They found that 3.5 severe bleeding events per 1,000 patients occurred in those patients taking a blood-thinner and an NSAID, compared to only 1.5 severe bleeding events per 1,000 in patients taking only the blood-thinner.

In addition, those patients who used NSAIDs were also more at risk for serious bleeding and blood clots, no matter which type of blood-thinner or NSAID they were taking. If they took more than the recommended dose of the NSAID, their risk went up even higher, and was “associated with a substantially increase hazard ratio for bleeding.”

The researchers concluded that doctors should “exercise caution” when it comes to prescribing NSAIDs in patients who are taking blood thinners for atrial fibrillation.

Yet Another Xarelto Side Effect

This study adds another concern for those taking anticoagulant drugs, especially “newer generation” brands like Xarelto and Pradaxa. The most common blood-thinning drug prior to the fairly recent release of these newer drugs was warfarin (Coumadin). Warfarin requires dietary restrictions, however, and regular blood monitoring.

When manufacturers released both Pradaxa and Xarelto, they advertised them as more convenient alternatives to warfarin. They required no dietary changes, no blood monitoring, and came in convenient once-daily doses.

Manufacturers failed to emphasize, however, the potential side effects, which can include gastrointestinal bleeding, stroke, hemorrhaging, and death. In addition, they failed to alert patients to the fact that there was no readily available antidote to Xarelto (or Pradaxa) excessive bleeding.

Whereas doctors can administer vitamin K injections to encourage blood clotting during an emergency bleeding event caused by warfarin, there is no such solution to Xarelto severe bleeding, making it much more serious and potentially deadly.

Bayer and Janssen are facing an increasing number of Xarelto lawsuits filed by plaintiffs who have suffered severe bleeding leading to hospitalization and sometimes death allegedly because of Xarelto.