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Serious Bleeding Side Effects
Xarelto® is the name under which Janssen Pharmaceuticals, Inc. markets a prescription anticoagulant medication generically called rivaroxaban.
Xarelto is a blood-thinning drug used to reduce the risk of ischemic stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem as well as treatments for deep vein thrombosis (DVT) and pulmonary embolism (PE).
Since coming on the market in 2011 the FDA has received numerous Adverse Event Reports involving the following Xarelto bleeding side effects:
- Serious bleeding side effects such as gastrointestinal (GI) bleeds and rectal bleeding
- Irreversible life-threatening bleeding events
- Trauma-induced atypical bleeding incidents due to lack of effective reversal agent
- Hemorrhages such as brain hemorrhage, intracranial hemorrhage, and hemorrhagic stroke
- Death as a result of excessive bleeding
Symptoms of these major bleeding complications include:
Coughing up blood
We point out that these two important facts about these bleeding events:
- Xarelto is associated with an increase in the rate of major gastrointestinal (GI) bleeding despite the lower rates of bleeding at other sites; and,
- A trend of higher bleeding risk was seen with advancing age.
Other Xarelto Side Effects
In addition, some medical studies have associated Xarelto with an increased risk of these other various side effects:
- Drug-induced liver injury (DILI)
- Thromboembolic complications such as cerebrovascular accident (CVA)
- Heart attack
- Myocardial infarction (MI)
- Acute coronary syndrome (ACS)
- Cardiac bleeds
We are handling personal injury and wrongful death lawsuits involving these Xarelto-related bleeding events as well as the other serious side effects.
We encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible drug injury case. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, nor some other lawyer — about your case based on his many years of experience.
In March 2017 the British Journal of Clinical Pharmacology published this article, “Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants”, which reports on the first retrospective cohort study to compare the risk of acute myocardial infarction (AMI), or heart attack, with use of direct-acting oral anticoagulants (DOACs) with that associated with vitamin K antagonists (VKAs), e.g., warfarin.
The bottom line is that the medical researchers conducting this study found a two-fold increase in the risk of heart attacks with use of Pradaxa (dabigatran) and Xarelto (rivaroxaban) in comparison with warfarin in patients using those drugs for atrial fibrillation (AF) therapy.
Specifically, from the Results section of the Abstract for this March 2017 medical journal article: “The risk of AMI was doubled when we compared current use of DOACs with current use of VKAs [adjusted HR 2.11; 95% confidence interval (CI) 1.08, 4.12]….”
And from the Discussion part of the full article:
In conclusion, our cohort study identified a twofold increase in the risk of AMI when using DOACs, [Xarelto (rivaroxaban)] or [Pradaxa (dabigatran)], in comparison with VKAs, in AF therapy in real-world patients. In addition, our results showed that in AF patients, the risk of AMI with current use of aspirin as monotherapy is higher than with current use of VKAs. VKAs probably have greater beneficial effects on AMI than DOACs. Ongoing research is needed as the use of DOACs increases in the population.
While this observational study reports that there is a correlation between the use of Xarelto (rivaroxaban) or Pradaxa (dabigatran) with an increased risk for myocardial infarction (MI), or heart attack, it is important to keep in mind that correlation does not prove causation.
Rather, in order to definitively answer the question “Do direct oral anticoagulants (DOACs) increase the risk for myocardial infarction (MI), or heart attack”, we will need a well-designed study. One hopes that Boehringer Ingelheim Pharmaceuticals (Pradaxa) or Janssen Pharmaceuticals (Xarelto), as the responsible drug companies, have such a drug-safety study currently underway or planned to begin soon.
Earlier articles by attorney Tom Lamb on the Side Effects Blog:
- No Clinical Trials Comparing The Safety Of Eliquis To Xarelto Done Yet
- Antidote Drug For Xarelto / Savaysa / Eliquis Is Denied FDA Approval
- Eliquis, Savaysa, And Xarelto Worry Doctors Because No Antidote, Still
- Eliquis Might Be Safer Than Xarelto, But Neither Has Approved Antidote
- Xarelto / Savaysa / Pradaxa / Eliquis: Effect Of Platelet Inhibitors
- No Antidotes For Eliquis, Savaysa, And Xarelto To Stop Acute Bleeding
- Xarelto – Liver Side Effects: Will New Warning Be Added To Drug Label?
- Xarelto: Drug-Induced Liver Injury Warning Should Be Added To Drug Label Prescribing Information For Xarelto Say Medical Researchers
- Eliquis And Xarelto, Like Pradaxa, Linked To Serious Bleeding Events Due To Fact No Antidote Available
- Drug Safety Significance Of Adverse Reactions Reports For Xarelto Blood Thinner Pill Is Uncertain, At Best
All content by attorney Tom Lamb