Two recent news stories shed more light on the anticoagulant Xarelto, the risks those who use it face and the problems that arose during a study comparing it to an older drug, warfarin. Xarelto is the subject of lawsuits by some users and surviving family members of users whose deaths may be related to the drug. The legal claims are largely based on incidents of uncontrolled bleeding that caused serious injuries or deaths.
People with an abnormal heartbeat known as atrial fibrillation who use Xarelto may be running a slightly greater chance of serious bleeding compared to those using the competing anticoagulant Pradaxa, according to WebMD. Many patients with atrial fibrillation use an anticoagulant to lessen the chance of suffering a stroke. Their downside is a risk of potentially fatal, uncontrollable bleeding.
Two newer drugs, Pradaxa and Xarelto, are being used instead of warfarin (whose brand name is Coumadin) which can be difficult to monitor and requires frequent blood tests. The problem is, Xarelto has no antidote:
- If you’re using Xarelto and major bleeding occurs (such as due to a vehicle accident) there is no antidote to help your blood clot to stop the bleeding. There have been cases of Xarelto users in that situation who have bled to death.
- A drug reversing the effects of Pradaxa has been approved.
Studies Show Increased Risk of Bleeding with Xarelto
Xarelto also appears to pose an increased risk of death for older patients compared to Pradaxa according to a study published in the journal JAMA Internal Medicine.
- Data was collected on nearly 119,000 Medicare patients with atrial fibrillation treated with either Xarelto or Pradaxa from November 2011 through June 2014.
- The chances of getting a stroke were about the same for users of both drugs.
- There was a small but statistically significant increase in the risk of bleeding in the brain and stomach for those using Xarelto.
- For patients 75 and older Xarelto was linked to a small but statistically significant increased risk of death. There was no proof Xarelto caused the deaths, just that there was, statistically, an association between taking the drug and a higher risk of death.
Defective Blood Testing Device
The circumstances surrounding a previous study does not shed a positive light on Bayer and Janssen Pharmaceuticals, the developers of Xarelto, reports the Pharmaceutical Journal, citing an article in the the BMJ. It reports that:
- Janssen may have kept information from the US Food and Drug Administration (FDA) concerning a defective blood testing device used in a trial of Xarelto according to an investigation by The BMJ.
- The company is accused of failing to disclose problems with an international normalized ratio (INR) device used to monitor warfarin levels in the study, which compared Xarelto and warfarin in preventing strokes in patients with atrial fibrillation.
- Neither Bayer nor the trial data safety monitoring board for the study were aware of the faulty device, though Janssen looked into the accuracy and reliability of the test during the study.
In February The BMJ, citing the problems with the INR, reported the study’s reports were not reliable. Both companies have denied the charge and The European Medicines Agency announced it looked into the issue but decided the INR didn’t impact the results. The FDA stated it is looking into the issue but hasn’t changed its recommendations for Xarelto use.
If you are on Xarelto, Pradaxa, or warfarin, or your physician recommends you start using a blood thinning medication, discuss the pros and cons of each, the risks that each carry and make an informed decision on the right medication for you. You may see advertisements for these drugs with images and language meant to give you peace of mind, but let the buyer beware.