Severe Bleeding Risk Linked to Xarelto

One of the newest blood thinners on the market, Xarelto, has been added to the list of drugs with dangerous side effects.  Xarelto was approved in 2011 as a potentially safer alternative to Warfarin, as Xarelto does not require regular blood monitoring or frequent doctor follow up.  Unfortunately, Xarelto has now shown to be on the same dangerous path as other blood thinners which have severe and lethal risks.  Xarelto was originally prescribed to prevent stroke or blood clots in patients suffering from atrial fibrillation and to reduce the risk of blood clots in patients undergoing knee or hip replacement surgery.  Xarelto was expanded in 2012 to allow the drug to be used as a treatment for deep vein thrombosis or pulmonary embolism.  The Food and Drug Administration (FDA) has received reports of dangerous blood clots, caused by uncontrollable bleeding.  Patients who have suffered side effects from this drug can experience high medical debt from emergency visits to the hospital and the costs of ongoing care, as well as lost wages from time away from work.

Heart doctors around the country have expressed concern about the safety of Xarelto, as it becomes more apparent that this drug, manufactured by Bayer and Janssen Pharmaceuticals, can cause serious medical problems.  Dr. Kenneth Bauer, head of hematology for the Veterans Administration health system in Boston, stated the FDA should never have approved Xarelto for patients with severe kidney dysfunction, since patients with this affliction were excluded from the pre-market studies regarding the drug.  The FDA, however, routinely approves adjusted doses of medicines and notes patients with severe liver dysfunction were included in smaller studies.   There have been over 2,100 reports made to the FDA regarding adverse side effects, with over 1,800 listing Xarelto as the primary culprit.  In the first three months of 2012, about 130,000 prescriptions were written for Xarelto in the United States, despite concerns that this drug has no known antidote for excessive bleeding.

The Institute for Safe Medication Practices has revealed that blood thinners such as Xarelto are the most dangerous drugs with the highest number of serious side effects reported to the FDA.  Some of the adverse effects of Xarelto include:

  • Intestinal Bleeding
  • Rectal Bleeding
  • Blood Clots
  • Brain Hemorrhaging
  • Uncontrolled Bleeding
  • Pulmonary Embolism
  • Deep Vein Thrombosis
  • Hemoglopin Decrease
  • Cerebrovascular Accidents
  • Hematoma
  • Edema Peripheral
  • Dyspnea
  • Death

Multi-district claims and litigation are now pending against Bayer and Janssen Pharmaceuticals over safety concerns.  Allegations against the manufacturers of Xarelto include failure to adequately test the drug prior to releasing it for purchase, as well as concealing important safety information.  Bayer and Janssen Pharmaceuticals have been attempting to get Xarelto approved for use in acute coronary syndrome (ACS) patients, but the FDA has turned them down on three separate occasions.  Xarelto generated sales of $1.3 billion last year and expects sales to reach $3.5 billion.  If you or a loved one has suffered from bleeding, blood clots, hemorrhaging or other adverse effects while taking Xarelto, please do not hesitate to contact Inserra & Kelley for a free initial evaluation of your claim.