Xarelto Monitoring May Identify Bleeding Risk Among AFib Patients: Study
The findings a new study suggest that many severe injuries or deaths associated with Xarelto bleeding problems may have been avoided if regular blood monitoring had been recommended for patients using the controversial anticoagulant, potentially allowing doctors to identify those who may be at the greatest risk of bleeds.
In a study published in the Journal of Cardiology, researchers found that measuring coagulation function with Xarelto may help doctors understand the effects of the drug on a particular patient and the associated bleeding risk.
The findings raise questions about marketing claims made by the drug makers, which have promoted Xarelto as superior to the decades-old anticoagulant Coumadin (warfarin) by indicating that the newer drug is easier to use because it does not require blood monitoring.
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According to researchers from the Nagoya University Graduate School of Medicine in Japan, the amount of time Xarelto was at its peak in patients, and most likely to cause uncontrollable bleeding events, was highly variable depending on a number of factors that may be identified by measuring coagulation function.
Many patients given Xarelto, particularly women, those given high doses, and those with high levels of brain natriuretic peptides, experienced peak levels, known as prothrombin time (PT), that lasted for prolonged periods of time. It was in these prolonged peak times where patients were most likely to suffer major bleeding events.
Unlike warfarin, which has an approved antidote that doctors can use to reverse the blood thinning effects of the medication, there is no approved Xarelto reversal agent, which has left doctors being unable to stop or control many of these bleeding events. Therefore, the findings of this latest study raise concerns about the way the drug was marketed and suggest that many users may have suffered severe bleeding injury due to the lack of warnings about the importance of blood monitoring on Xarelto.
Xarelto Bleeding Risk
Xarelto (Rivaroxaban) was introduced in late 2011, as a joint development by Bayer and Johnson & Johnson’s Janssen subsidiary. It is part of a new generation of anticoagulants, known as “direct thrombin inhibitors,” which are designed to reduce the risk of blood clots and strokes by thinning the blood.
While the medication has proven to be equally as effective as warfarin, which has been the go-to anticoagulation therapy for years, Bayer and Johnson & Johnson have attempted to capture this lucrative market by promoting their more expensive Xarelto drug as easier to take, indicating that patients can avoid the need for regular blood monitoring during treatment.
Amid aggressive promotion of the medication to doctors and directly to consumers, Xarelto sales have grown quickly, with estimates suggesting that it may soon gain blockbuster status, with more than $1 billion in annual sales.
While the medical community has been quick to adopt use of Xarelto over warfarin, there have increasing reports of severe and uncontrollable bleeding associated with Xarelto. However, it now appears that many of these injuries and deaths may have been avoided if Bayer and Johnson & Johnson had provided warnings about the importance of blood monitoring.
Blood Monitoring on Xarelto
In this latest study, researchers gave Xarelto to 136 patients with non-valvular atrial fibrillation. The mean age of the patients was about 74 years. Out of that group, 46 had never taken an anticoagulant before, and 29 of those experienced prolong PT, which was only discovered by regular blood monitoring.
Bleeding events happened in 25 of the patients, with four suffering major bleeds. Two of the major cases involved intracranial hemorrhage, and there was one case of hypermenorrhea, and one case of upper gastrointestinal tract bleeding.
Patients with prolonged peak times of Xarelto in their blood experienced significantly more bleeding events than other patients, according to the findings
“Treating the patients with rivaroxaban at a fixed dose and without measuring their coagulation function may expose them to the risk of hemorrhage in the future,” the researchers warned. “Measuring PT may help to screen for bleeding risk.”
Researchers concluded that blood monitoring on Xarelto was clinically useful, indicating that measuring PT may help screen for bleeding risk.
The findings of this new study add further support for a mounting number of Xarelto lawsuits being pursued by individuals throughout the U.S., which allege that hundreds of severe bleeding injuries and deaths may have been avoided if the manufacturers had provided stronger warnings about the risks associated with Xarelto.
In addition to claims over the failure to warn about the importance of Xarelto monitoring, the complaints allege that Bayer and Johnson & Johnson failed to adequately disclose the lack of an approved antidote that doctors may be able to use to reverse bleeds that develop while using the medication.
Many of the complaints allege that after identifying the spike in reports of severe bleeding problems, the drug makers should have issued a Xarelto recall until a safe and effective reversal agent can be identified.
In response to the mounting number of cases being filed in U.S. District Courts nationwide, a motion was filed earlier this month seeking to consolidate the federal Xarelto litigation before on judge for centralized pretrial proceedings.
While there are currently 21 cases pending in 10 different federal district courts, many Xarelto injury lawyers reviewing potential claims have suggested that there could soon be hundreds, and possibly even thousands, of claims brought on behalf of individuals hospitalized with severe internal bleeds, brain hemorrhages, hemorrhagic strokes or other bleeding problems while taking Xarelto.
Former users and family members of individuals who have died while taking the medication claim that the injuries may have been avoided if Bayer and Johnson & Johnson had provided proper warnings about the importance of blood monitoring on Xarelto and the lack of an approved reversal agent.
BrianOctober 23, 2014 at 10:25 am
This important article is a must read for any patient who is or may become a candidate for anticoagulation therapy. The article and the number of suits filed to date would suggest that the manufactures claims that the drug is safe and does not require monitoring is greatly exaggerated. Yes there is some minor inconvenience in having ones blood tested while on Heparin or Coumadin. In our estimati[Show More]This important article is a must read for any patient who is or may become a candidate for anticoagulation therapy. The article and the number of suits filed to date would suggest that the manufactures claims that the drug is safe and does not require monitoring is greatly exaggerated. Yes there is some minor inconvenience in having ones blood tested while on Heparin or Coumadin. In our estimation it is a small price to pay given the immediate feedback such monitoring provides. This monitoring allows the dosage of anticoagulants to be adjusted to keep the patient as safe as possible. Fortunately in the event of bleeding complications these drugs can be rapidly reversed. The same cannot be said for Xarelto. Heaven help the Xarelto patient who is bleeding and the drug cannot be reversed.
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