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Xarelto Internal Bleeding

xarelto bottleXarelto is an anticoagulant (or blood thinner) produced by Bayer and marketed by Janssen Pharmaceuticals, part of Johnson & Johnson.

When Xarelto (rivaroxaban) was approved in 2011, it was one of a new generation of blood thinners (along with Pradaxa, Eliquis, and others) that held out the promise of a safer, easier way to treat patients for various heart-related conditions. These drugs, so called “Factor Xa” blood thinners, rose in popularity, with Xarelto netting $1.3 billion for Bayer in 2013 alone.

But while all blood thinners can pose bleeding risks, internal bleeding caused by Xarelto currently has no known antidote. And many critics believe that Bayer provided insufficient warning about the risks associated with the drug.

Xarelto bleeding complications

Prior to the arrival of Pradaxa, Xarelto, and other new anticoagulants on the market, doctors typically treated patients at risk for developing blood clots with warfarin (marketed under the brand name Coumadin). Warfarin could pose bleeding risks; however, doctors were generally able to treat emergencies with Vitamin K. No such antidote exists for Xarelto and the other recently-introduced blood thinners, leaving doctors with few options when a patient is experiencing internal hemorrhaging.

Serious internal bleeding complications reported in connection to Xarelto include:

  • Intracerebral (brain) hemorrhage (ICH)
  • Spinal/epidural hematomas
  • Intestinal/abdominal bleeding
  • Rectal bleeding
  • Bleeding associated with other organs

Though doctors have few tools at their disposal (including blood transfusion or compression of the site of bleeding) to treat serious complications, a patient’s odds improve if he or she gets to the doctor quickly after discerning warning signs.

Certain patients may be at higher risk of bleeding, such as those with kidney or liver problems, patients with a past history of bleeding problems, or pregnant women, all of whom should not take Xarelto.

Studies of Xarelto internal bleeding risk

Recent studies have shed light on bleeding risks associated with Xarelto, especially in three areas:

  1. The actual risk of bleeding events. Researchers from Southlake Regional Health Centre in Ontario, Canada, who studied 901 patients receiving warfarin, Xarelto, or Pradaxa, found that the risk of strokes, bleeding events, or other side effects was equally low for all patients, thus calling into question a supposed benefit of the new drugs. An article published in August, 2014 in the Journal of Neurosurgery suggests that the risk for abdominal bleeding may be higher for Xarelto than for warfarin.
  2. The lack of antidote. The Journal of Neurosurgery article also points out the implications for a lack of reversal agent in the case of intracerebral hemorrhage (ICH): such a lack slows the response time during a situation in which rapid response is crucial for the patient’s survival.
  3. The need for monitoring. One of the main selling points for the new drugs is that they are far more convenient and “user-friendly” than warfarin, which required frequent monitoring and blood tests to be safe. But the Canadian study cited above also found that patients taking Xarelto experienced far fewer dangerous bleeding events when they were monitored much more closely than manufacturers had suggested.

FDA weighs in on Xarelto side effects

The FDA received 2081 serious adverse event (SAE) reports associated with Xarelto during the 2012 fiscal year alone. 151 SAEs involved fatalities, three times the number associated with warfarin that same year. The Institution for Safe Medication Practices reported last spring that Xarelto had surpassed Pradaxa, a drug that was introduced earlier.

Whereas the administration approved 6 different indications for the drug initially, they rejected three different requests to further broaden the drug’s applications starting in 2013, noting dangers associated with bleeding. The FDA sent Bayer a warning letter in June of the same year for downplaying risks of spinal hemorrhage.

And in January of 2014, they required more specific warning labels concerning the lack of a reversal agent for Xarelto.

Bleeding risks listed on the Xarelto warning label

Currently, a “black box” warning (the strongest available) on the Xarelto label cautions doctors and patients about the risks of spinal hematoma and associated paralysis. In January of 2014, the FDA mandated that Bayer add language to the warning label to indicate that a “specific antidote for rivaroxaban is not available” and that vitamin K and other agents do not “affect the anticoagulant activity of rivaroxaban.”

Xarelto injury lawsuits

Patients suffering harm due to bleeding complications sustained while taking Xarelto continue to file civil lawsuits against Bayer, alleging that they were not sufficiently warned about the drug’s risks or its lack of antidote. Enough cases were filed by the end of 2014 to establish a multidistrict litigation (MDL) consolidating over two dozen Xarelto lawsuits in Louisiana and more than 80 cases shortly afterward as part of a mass tort in Pennsylvania.

Many additional cases have been filed since that time; Xarelto bleeding lawsuits now number in the hundreds.


  • FDA, Medication Guide: Xarelto http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280333.pdf

  • FDA, Warning Letter, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM357833.pdf

  • Reuters, Insight: Top heart doctors fret over new blood thinners http://www.reuters.com/article/2012/06/14/us-drugs-bloodthinners-idUSBRE85D06G20120614

  • Reuters, Bayer faces lawsuits in United States over Xarelto: paper http://www.reuters.com/article/2014/06/14/us-bayer-suit-idUSKBN0EP0HW20140614

  • ISMP, Quarterly Report, http://www.ismp.org/quarterwatch/pdfs/2013Q1.pdf

  • Reuters, Reports of side-effects from Bayer's Xarelto grow: Spiegel http://www.reuters.com/article/2013/09/08/us-bayer-xarelto-idUSBRE9870AH20130908

  • Huffington Post, Pradaxa And Xarelto: Top Heart Doctors Concerned Over New Blood Thinners, http://www.huffingtonpost.com/2012/06/14/pradaxa-xarelto-blood-thinner-doctors-heart_n_1595971.html

  • Cleveland Clinic Journal of Medicine, Practical management of bleeding due to the anticoagulants dabigatran, rivaroxaban, and apixaban http://www.ccjm.org/content/80/7/443.full

  • Journal of Neurosurgery, Race against the clock: Overcoming challenges in the management of anticoagulant-associated intracerebral hemorrhage http://thejns.org/doi/pdf/10.3171/2014.8.paradigm

  • PubMed Health, Safety and efficacy of dabigatran compared with warfarin for patients undergoing radiofrequency catheter ablation of atrial fibrillation: a meta-analysis http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0058819/