COVID-19 Update >> We Are Open 24/7
The Product Lawyers Defective Products Lawyers Logo
A National Alliance Of Products Lawyers
Handling Complex Injury Cases
(877) 671-6480
INTERNAL BLEEDING AFTER XARELTO?

Xarelto Recalls & FDA Warnings

With no recall in sight, the blockbuster anticoagulant drug Xarelto remains on the market today. But a number of FDA warnings have alerted patients to several of the drug’s most prominent risks:

  • Internal and external bleeding
  • No available antidote
  • Thrombocytopenia

While this litigation has now closed, compensation may be available for similar cases. If you or a loved one suffered injury, contact our lawyers today for a free consultation. Learn more about Breast Implant Cancer TV Commercials: What Women Need To Know.

Litigation Status: Inactive
Accepting Clients: No
Content Author: Laurence Banville
Edited By: Emily Smith
Published: 0707/0202/15151515
Fact checked on: 0707/0202/15151515Resources Cited in this Article
"The lawyers that form this alliance truly work on these cases and often take leadership positions on the steering committees that litigate them." - Laurence Banville

At this point in time, Xarelto has not been recalled by the Food and Drug Administration, but since its release in 2011 the agency has issued several important safety warnings, including two “black box warnings”. These black box warnings are the strictest warnings that the FDA can issue to a drug short of recalling it.  These warnings usually mean that there is “reasonable evidence” of a hazard associated with taking the drug.

Related Reading: Miralax Side Effects: Are Children At Risk Of Seizures?

Timeline of Xarelto Warnings

In August 2013, the FDA announced its first black box warning for Xarelto.  The black box warning stated that patients who prematurely discontinued Xarelto usage were at a higher risk for blood clots, deep vein thrombosis, and epidural/spinal hematoma.

Bleeding Risks Highlighted In FDA Safety Announcement

A few months later in January 2014, a “warning/precaution” was issued by the FDA in regards to Xarelto and Rivaroxaban, the generic form of the drug, stating that they were aware of the bleeding risk associated with these medications.  The warning went on to recommend blood transfusions or replacement if a patient experienced blood loss while taking Xarelto.

This warning also discussed that there is no reversal agent or antidote for Xarelto.  With most other blood thinners, a doctor can administer vitamin K or protamine sulfate to counteract the anticoagulant properties of a blood thinner in an emergency situation.  Neither of these antidotes will work with Xarelto though because Xarelto blocks Thrombin.

Epidural & Spinal Puncture Patients

Not too long after that, in March 2014 the FDA issued their second black box warning for Xarelto.  This warning was in regard to patients who were undergoing an epidural (spinal anesthesia/analgesia) or spinal puncture.  The warning directed that if a person taking Xarelto needed to undergo this procedure that they wait until Xarelto has been flushed from their system.

Thrombocytopenia

The next warning for Xarelto came in December 2014 when the FDA issued an “Adverse Reaction” report on Xarelto. This report was in regards to a condition called thrombocytopenia and warned that Xarelto may be a cause of it.  Thrombocytopenia is when the body suffers from low blood platelet counts and can result in internal bleeding because blood platelets are crucial in the formation of blood clots.

This FDA report also changed the description of an adverse reaction from “cytolytic hepatitis” to “hepatitis”, including hepatocellular injury, a major liver injury.

Dangerous Drug Interactions

The FDA issued another warning in December 2014 regarding drug interactions with Xarelto.  The warning listed several drugs that should not be taken with Xarelto.  The complete list of drugs is below:

  • Itraconazole – Sporanox and Onmel
  • lopinavir – Kaletra
  • Ritonavir – Norvir
  • Indinavir – Crixivan
  • Conivaptan – Vaprisol
  • Carbamazepine – Tegretol, Tegretol-XR, Equetro, Carbatrol, Epitol, and Teril
  • Phenytoin – Dilantin
  • Rifampin – Rifater, Rifamate, Rimactane, and Rifadin
  • St. John’s wort – Hypericum Perforatum

In addition, the FDA warned that Xarelto has not been tested in patients who have a prosthetic heart valve, and warned that as a result, Xarelto should not be taken by such patients.

Elmiron Lawsuit For Macular Degeneration
  • Contact Info
  • Case Details

Free Case Evaluation

Medical Researcher In Lab
Contact Our Consumer Advocates Today
Call Our 24/7 Recalled Products Helpline Now
(877) 671-6480
© 2020 TheProductLawyers.com. All rights reserved.

TheProductLawyers.com is primarily sponsored by Banville Law, PLLC, a New York-based law firm, with attorneys licensed to practice law in the state of New York. and the District of Columbia. TheProductLawyers.com is an alliance of attorneys across the United States who dedicate their professional careers to representing individuals who were seriously injured by defective products, drugs and medical devices. This website is to be considered ATTORNEY ADVERTISING. Past settlement and verdict values are no guarantee of similar future outcomes. TheProductLawyers.com is not a law firm. TheProductsLawyers.com has a team of consumer advocates who can help connect consumers or patients to members of the TheProductLawyers.com alliance who are experienced in a specific type of case for a free legal consultation.

SitemapDisclaimer / Terms Of Service & Privacy Policy