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In October 2012, the Institute for Safe Medication Practices (ISMP) published a study reviewing the approval of XARELTO® (rivaroxaban) by the U.S. Food and Drug Administration (FDA) for short-term treatment of venous and pulmonary embolisms (blood clots) in patients undergoing joint replacement surgery. Among the findings in the study:

  • During FDA trials, 15 percent of 14,000 patients experienced some form of internal bleeding. (Despite this risk, the FDA approved XARELTO® for both short-term blood clot prevention and long-term use to prevent stroke in patients with abnormal heartbeats.)
  • In the first quarter of 2012, 356 serious injuries occurred in which XARELTO® was believed to be the underlying cause. This number was up 178 percent from 128 cases in the previous quarter.
  • Of the 356 complications in Q1 2012, 44 percent included blood clots, which XARELTO® had been prescribed to prevent.
  • XARELTO® resulted in a significantly higher occurrence of blood clots and strokes compared with similar medications like dabigatran (Pradaxa), warfarin, and enoxaparin.
  • The ISMP concluded that orally ingested blood thinners were “among the riskiest of all outpatient drug treatments” due to high instances of internal bleeding.

In May 2014, the ISMP published another report with new data collected during the first quarter of 2013. This study revealed a positive correlation between the increase of XARELTO® prescriptions and serious adverse health events.  The report also demonstrated that strokes and internal bleeding events increased as XARELTO® prescriptions increased.

Similarly, the FDA also reported thousands of adverse events related to Pradaxa®, including 542 that were fatal. In 2011, the ISMP released a report that linked more deaths and injuries related to Pradaxa® that year than any of the 800 drugs it reviewed.

Bottom line: Pradaxa® and XARELTO® are dangerous drugs. In addition to the conditions described above, Pradaxa® and XARELTO® have been linked to a variety of other serious health risks.

  • Intracranial hemorrhage (bleeding in the brain)
  • Retinal hemorrhages (bleeding in the eye)
  • Spinal and epidural hematoma (blood clots)
  • Gastrointestinal hemorrhage (stomach bleeding)
  • Adrenal bleeding
  • Hemoglobin decrease
  • Blood clots, including deep vein thrombosis and pulmonary embolism
  • Unusual bleeding from the nose or gums or abnormally heavy menstrual bleeding
  • Severe/long-lasting external bleeding
  • Stroke
  • Death

These complications are not rare. Estimates say as many as 3.5 percent of XARELTO® users will suffer internal bleeding, and any of the above-mentioned conditions has the potential to cause extreme discomfort, permanent impairment, and even death.

Granted, most anticoagulant (blood thinner) medications carry these same risks, and in most cases the risks can be managed with reversal agents or antidotes which restore the blood’s ability to clot. For older anticoagulant medications like warfarin, many reversal agents are available, including prothrombin complex concentrates (PCCs), recombinant activated factor VII (rFVIIa), plasma, and vitamin K.

However, there is no known reversal agent for Pradaxa® or XARELTO®, so hemorrhaging will continue until the drug is flushed out of the system, which can take from two to seven days. This is especially dangerous for older people because their metabolism is slower and the drug lingers longer in their systems. By the time the drug is cleared from their bodies, elder patients may have suffered irreversible damage or even death.

If you are taking Pradaxa® or XARELTO®, it is important to maintain heightened awareness of your physical state and seek medical help immediately if you begin to experience unusual symptoms. Some indicators to watch for include:

  • Dizziness/lightheadedness
  • Muscle pain
  • Shortness of breath
  • Hemorrhaging in the eye
  • Fainting
  • Hematoma (bruising)
  • Nausea/vomiting (especially blood in your vomit—looks like coffee grounds)
  • Rectal bleeding or bright red or black stools
  • Chest pain
  • Urogenital bleeding (red, pink, or brown urine, vaginal bleeding, or heavier-than-normal menstrual bleeding)
  • Rapid heartbeat
  • Nose bleeding
  • Headache
  • Unusual bleeding from gums
  • Fever
  • Edema (inflammation or swelling)
  • Pain, swelling or new drainage at wound sites
  • Coughing up blood or blood clots
  • Any bleeding that you cannot control

In addition, if taking Pradaxa® or XARELTO®, you must exercise extreme caution with regard to other medications. lists 334 drugs that are known to interact with XARELTO® and 363 drugs that are known to interact with Pradaxa®. Some common pharmaceuticals to avoid are those that increase the risk of bleeding, including:

  • Aspirin or aspirin-containing products
  • Non-steroidal anti-inflammatory drugs (NSAIDs)
  • Warfarin sodium (Coumadin®, Jantoven®)
  • Any medicine that contains heparin
  • Clopidogrel (Plavix®)
  • Other medicines used to prevent or treat blood clots

If you are taking Pradaxa® or XARELTO® and have experienced any of the above-described complications, call us now at (800) 210-4539 or fill out our online form for a free consultation. Our experienced team of attorneys will listen to your story, assess your chances for a successful claim, advise you on how to move forward, and help you do the legwork. We can assist you in obtaining a just settlement for your pain and suffering.

We Can Help You

If you or a loved one have suffered because of a dangerous drug or device, or have been injured, you may be entitled to financial compensation. Recovery may include compensations for your medical bills, pain and suffering, and loss of wages. Please contact Avram Blair & Associates, P.C. immediately. We will spend time evaluating any potential claims. Call us toll-free (888) 384-5745 or fill out the form below and a Legal Intake Specialist will reach out to you.

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