Xarelto Side Effects

Xarelto (rivaroxaban) is an anticoagulant medication indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery. It is also indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It belongs to a distinct class of anticoagulants known as direct factor Xa inhibitors. Through 10/14/2016 there have been 58,627 cases where XARELTO has been reported as the primary suspect drug.

Class

Direct factor Xa inhibitors

Indications

Thromboembolic Events

SPAF (Stroke Prevention in Atrial Fibrillation Patients)

Pulmonary Embolism

Mechanism of Action

Factor Xa Inhibitors

Most Serious Side Effects from Xarelto

Adverse EventLabel StatusReported CasesIncidence Rate
Gastrointestinal haemorrhageLabeled100540.002609000076
HaemorrhageLabeled35780.000918100006
Internal haemorrhageNot Labeled28100.001072000014
Pulmonary embolismLabeled25840.000643000007
Deep vein thrombosisLabeled23700.000586999988
EpistaxisLabeled22160.000565700000
Rectal haemorrhageLabeled21390.000561100023
DeathLabeled16230.000416600000
Cerebral haemorrhageLabeled14150.000370599999

Most Reported Side Effects of Xarelto

Adverse EventLabel StatusReported CasesIncidence Rate
Gastrointestinal haemorrhageLabeled100540.002609000076
HaemorrhageLabeled35780.000918100006
Internal haemorrhageNot Labeled28100.001072000014
Pulmonary embolismLabeled25840.000643000007
Deep vein thrombosisLabeled23700.000586999988
EpistaxisLabeled22160.000565700000
Cerebrovascular accidentLabeled21930.000552600017
Rectal haemorrhageLabeled21390.000561100023
AnaemiaNot Labeled19010.000497600005
HaematuriaLabeled16660.000424200000
DeathLabeled16230.000416600000
Drug ineffectiveNot Labeled15660.000389699999
Cerebral haemorrhageLabeled14150.000370599999
FallNot Labeled12990.000328199996
Haemoglobin decreasedLabeled12910.000327899994
Upper gastrointestinal haemorrhageLabeled12800.000326200010
ThrombosisLabeled12680.000316499994
Off label useNot Labeled11000.000290800002
Haemorrhage intracranialLabeled10790.000276300008
Incorrect dose administeredNot Labeled10480.000280800014
DizzinessNot Labeled10440.000261800014
HaematomaLabeled10400.000262499991
DyspnoeaNot Labeled9830.000247699994
Acute kidney injuryLabeled9660.000244299998
Drug prescribing errorNot Labeled9350.000228999997
Inappropriate schedule of drug administrationNot Labeled9090.000226400007
Drug dose omissionNot Labeled9020.000237600005
HeadacheNot Labeled8690.000218600006
Ischaemic strokeLabeled8100.000205799995
AstheniaLabeled8080.000205499993
FatigueLabeled8000.000199999995
ContusionLabeled7980.000201200004
Lower gastrointestinal haemorrhageLabeled7850.000213199994
Vaginal haemorrhageLabeled7430.000189800005
Haemorrhagic strokeLabeled7210.000190299994
International normalised ratio increasedNot Labeled7190.000182000003
Haemorrhagic anaemiaLabeled6970.000192399995
NauseaNot Labeled6930.000175199995
RashNot Labeled6780.000167200007
HaemoptysisLabeled6700.000172800006
Blood urine presentLabeled6430.000162199998
Subdural haematomaLabeled6240.000173099994
Pain in extremityLabeled6230.000157100003
HaematocheziaLabeled6150.000160700001
MalaiseNot Labeled5670.000143700003
MenorrhagiaLabeled5480.000137199997
Cerebral infarctionLabeled5400.000144399994
PruritusLabeled5290.000130400003
MelaenaLabeled5250.000132600006
DiarrhoeaNot Labeled5180.000131399996

Lawsuits are currently being filed on behalf of individuals who experienced Xarelto Side Effects as well as Pradaxa Side Effects.

The FDA approved Xarelto in 2011 for use in reducing the risk of blood clots in patients undergoing knee and hip replacement surgery. Later that same year, approval was extended for reducing the risk of blood clots and stroke in patients with non-valvular atrial fibrillation.  Xarelto’s manufacturers marketed the medication as a more convenient alternative to the popular warfarin (brand name Coumadin), which requires frequent blood monitoring.

FDA Warns of Xarelto Side Effects

All drugs have side effects, it is only when patients are not warned of side effects that TruLaw takes action to get information out to the public.  In the case of Xarelto, bleeding while on anticoagulants is not unusual, but many patients are not aware that bleeding events while on Xarelto cant be easily controlled because there is no reversal agent.

In January 2014, the FDA added a section to the Warnings and Precautions portion of the Xarelto medication insert.  It warned Xarelto has no antidote and advises patients to watch for signs of excessive bleeding.

Mayo Clinic Study Warns of Dangers of Xarelto Side Effects

Recent findings regarding dangerous side effects now question the safety of Xarelto’s one-size-fits-all approach, which does not require frequent follow-up. Some of these side effects include:

A study conducted by the Mayo Clinic and published in the medical journal Gastroenterology concluded that the direct oral anticoagulant (DOAC) Xarelto was associated with more gastrointestinal bleeding events than competitors Eliquis and Pradaxa, although all three medications are associated with increased GI bleeding.

Mayo Clinic researchers examined data from approximately 57,000 patients with non-valve atrial fibrillation who were prescribed Xarelto, Eliquis, or Pradaxa between October 1, 2010, and February 28, 2015, and experienced gastrointestinal bleeding.

The study findings included:

Manufacturers of direct oral anticoagulants (DOAC) claim that the drugs are a better replacement for warfarin because of ease of use and a reduction in the amount of blood monitoring required to maintain a proper dosage.

JAMA Study Warns of Dangers of Xarelto Side Effects

A new study published in the November 2016 of JAMA Internal Medicine associated Xarelto (rivaroxaban) use with increased bleeding around or within the brain and major hematoma events as compared with Pradaxa (dabigatran) use.

The researchers found that treatment with Xarelto 20 mg once a day led to significant increases in intracranial hemorrhage, major extracranial bleeding, and major gastrointestinal bleeding, compared with Pradaxa 150 mg taken twice daily. Both Xarelto and Pradaxa are non-vitamin K anticoagulants that have been approved by the U.S. Food and Drug Administration (FDA) for use as stroke prevention in patients with nonvalvular atrial fibrillation (AF).

 

References


  1. FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa. (2015, October 16). Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm
  2. In Re:Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, http://www.ilsd.uscourts.gov/mdl/mdl2385.aspx
  3. In Re:Xarelto Products Liability Litigation, MDL. No. 2592, http://www.laed.uscourts.gov/xarelto
  4. A patient's guide to taking warfarin. (n.d.). Retrieved from http://www.heart.org/HEARTORG/Conditions/Arrhythmia/PreventionTreatmentofArrhythmia/A-Patients-Guide-to-Taking-Warfarin_UCM_444996_Article.jsp#.WCyRKeErI_U

  5. Cerebral & intracerebral hemorrhage | cleveland clinic. (2013). Retrieved from http://my.clevelandclinic.org/services/neurological_institute/cerebrovascular-center/diseases-conditions/hic-intracranial-hemorrhage

  6. Definition of extracranial hematoma. (2012, June 14). Retrieved from http://www.medicinenet.com/script/main/art.asp?articlekey=32328

  7. FDA approves Xarelto to prevent stroke in people with common type of abnormal heart rhythm. (2011, November 11). Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278646.htm

  8. Idarucizumab. (2015, October 16). Retrieved from http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm467396.htm