The blood thinner Xarelto (rivaroxban) contributed to the death of a New Zealand man who was using the drug as part of a clinical trial. The victim was a participant in a drug study testing the safety and efficacy of the anticoagulant to prevent strokes in atrial fibrillation patients in order to gain clearance in New Zealand. The drug was approved in the United States in November 2011 for the same indication.

The 59-year-old male victim’s direct cause of death was listed as cardio respiratory arrest, but the coroner says he suffered significant chest injuries and an unusually large blood loss following a crash. The death report identified Xarelto in the man’s system, and found that he died “most probably due to hypovalemic shock – an emergency condition in which severe blood and fluid loss make the heart unable to pump enough blood to the body.”

The deceased was one of 14,200 people taking part in the medical trial led by Bayer Health Care. Participants were randomly assigned to take Xarelto or warfarin, a blood thinner that has been on the market for more than 50 years.

Drug companies have been searching for a safer alternative to warfarin for decades. Warfarin has a proven track record of preventing strokes in patients with atrial fibrillation, but it also has a long list of food and drug interactions and can cause internal bleeds. Thus, patients prescribed the drug must be monitored on a regular basis.

In 2010, the United States Food and Drug Administration (FDA) approved the blood thinner Pradaxa (dabigatran), the first alternative to warfarin for atrial patients. Both Pradaxa and Xarelto are in a class of medications known as direct thrombin inhibitors.

Pradaxa was heralded as a safer alternative to warfarin, but a review of adverse events reported to the FDA’s MedWatch program found that the drug has been associated with hundreds of bleeding events, some of which have been fatal.

Xalerto is also approved for use in the United States to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery. In June, the FDA rejected Bayer’s bid to approve Xarelto for the treatment of patients with acute coronary syndrome, or ACS.

Source: NZ Herald

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