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Australian TGA Questions Need for Pradaxa and Xarelto Blood Monitoring

Xarelto boxA recent review issued by the Australian Therapeutic Goods Administration (TGA) suggests that routine blood monitoring for new oral anticoagulants (NOAC) such as Pradaxa and Xarelto is not recommended at this time. The Aussie agency concluded that there is a lack of substantial manufacturer-conducted data on the effects of such monitoring for enhancing the safety of the drugs.

Both Pradaxa and Xarelto have been linked to uncontrollable bleeding events, including intracranial hemorrhages, gastrointestinal bleeds and bleeding within internal organs.  The TGA’s review contradicts earlier research conducted in Japan and published in the Journal of Cardiology, which determined that blood monitoring for patients taking Xarelto was clinically useful, as it helped doctors screen for patients with increased bleeding risks.

No evidence to support blood monitoring for NOACs

The Australian TGA undertook the review in the wake of studies and published literature that suggested the anticoagulants’ safety might be improved with the addition of regular blood monitoring, which is required for Warfarin (Coumadin) – a blood thinner that has been well-tolerated by patients for more than 50 years.

According to the Australian Therapeutic Goods Administration, “NOAC sponsors have not undertaken dedicated studies to evaluate the effects of routine plasma monitoring on the safety profile of their medicines, as such monitoring is not likely to significantly add to the use of clinical parameters to determine bleeding risk…Therefore, the TGA’s review has found there is no evidence at this time to support a recommendation for routine plasma monitoring in patients being treated with these medicines.”

The findings of this new review may be cold comfort to those who have taken Xarelto to help prevent dangerous blood clots, only to suffer a life-threatening bleed. The main contention among patients who have taken legal action is that unlike Warfarin, which has a viable antidote to stop hemorrhages, there is no reversal agent for Xarelto bleeding, once it begins. Despite blood transfusions and emergency medical treatment, some patients are unable to recover fully, leaving them with serious injuries and a host of financial losses.

Undisclosed Xarelto side effects prompt wave of litigation

Product liability complaints filed by Xarelto patients, and in some instances the relatives of the deceased, have accumulated against Bayer Healthcare and Janssen Pharmaceuticals. Claimants argue that they were not sufficiently warned by the defendant that Xarelto had no proven antidote, and that the companies should be held liable for fraudulent misrepresentation regarding the deceptive promotional claims of its drug, which was advertised as a more convenient and hassle-free alternative to Warfarin.

In light of mounting civil actions alleging GI bleeds, strokes, embolisms and wrongful death caused by Xarelto, cases have been coordinated on the state and federal level. Similar Xarelto lawsuits brought in federal courts have been centralized in the Eastern District of Louisiana under multidistrict litigation No. 2592, while state filings were coordinated as a mass tort in the Philadelphia Court of Common Pleas.

Undeterred by legal action, the defendants continue to stand behind the safety and efficacy of their direct-thrombin inhibitor Xarelto, despite escalating numbers of adverse event reports regarding fatal bleeding events.

Coordinated litigation often proves useful in large numbers of complaints involving similar allegations and issues of fact, as it allows parties to share in discovery processes while reducing chances of inconsistent pretrial rulings. In some cases, MDL and mass tort proceedings may encourage defendants to reach out for settlement negotiations, especially if bellwether trials produce large verdicts on behalf of the plaintiffs.

  1. Australian Government, Department of Health New oral anticoagulants - apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto)

  2. FDA, Xarelto Safety Guide

  3. Journal of Cardiology, Clinical usefulness of measuring prothrombin time and soluble fibrin levels in Japanese patients with atrial fibrillation receiving rivaroxaban