Xarelto: Drug-Induced Liver Injury Warning Should Be Added To Drug Label Prescribing Information For Xarelto Say Medical Researchers

November 10, 2014

Medical Journal Article Reports On Two Patients Who Experienced Severe Liver Damage Onset During Xarelto Treatment

(Posted by Tom Lamb at DrugInjuryWatch.com)

Most adverse drug reaction case reports associated with the still relatively new anticoagulant Xarelto (rivaroxaban) involve serious bleeding side effects such as gastrointestinal (GI) bleeds and rectal bleeding as well as irreversible life-threatening trauma-induced atypical bleeding incidents.

A recent article, however, published by the medical journal JAMA Internal Medicine, "Symptomatic Hepatocellular Liver Injury With Hyperbilirubinemia in Two Patients Treated With Rivaroxaban", discusses a different serious Xarelto side effect: drug-induced liver injury / liver damage.

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From a medical site summary about this recent Xarelto liver safety study, "Rivaroxaban and Liver Injury: Case Studies Add to Safety Questions", we get these facts:

A case study in JAMA Internal Medicine reports on two patients that experienced severe liver injury onset during treatment with the oral anticoagulant [Xarelto (rivaroxaban)]. The first patient was a 52-year-old man who developed severe lobular hepatitis two months after initiation of [Xarelto (rivaroxaban)] 10mg/day for the prevention of deep vein thrombosis (DVT) after internal fixation of a tibia fracture. The preserved lobular architecture and lack of fibrosis of portal tract were consistent with a drug-related liver injury…. The second patient, a 73-year-old woman prescribed 10mg/day of [Xarelto (rivaroxaban)] after a total knee replacement for the prevention of DVT, experienced mixed liver injury but liver enzyme levels and bilirubin concentration restored to normal levels after 14 days of [Xarelto (rivaroxaban)] cessation…. The authors speculate that [Xarelto (rivaroxaban)] was most likely the cause of drug-induced liver injury (DILI) in both patients and that physicians should be aware of this potentially severe adverse drug reaction. They also emphasize that a warning regarding symptomatic liver injury should be included in the drug label.

We will continue to watch for liver failure, drug-induced hepatitis, and liver damage drug injury cases possibly associated with Xarelto blood thinner treatment.

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10 responses to “Xarelto: Drug-Induced Liver Injury Warning Should Be Added To Drug Label Prescribing Information For Xarelto Say Medical Researchers”

Kristin

February 21, 2016

I am a healthy 36 year old female and also developed the aforementioned condition after being treated with xarelto. Thank you for addressing this information.

Reply
6547palms@gmail.com

February 27, 2016

My husband was prescribed Xarelto 20mg two years ago. All his liver enzymes have come back normal. He now has cancerous lesions on his liver, with a large lesion between the esophagus and the stomach. Biopsy came back positive for cancer. He has Afib a contributing cause to 17 TIA’s and two strokes between 2010 and 2011 with 100% blockage of the vertebral artery. His initial oncology consult is March 1st. I am suspicious of the Xarelto. He was recovering from what we thought was a virus since December 2015 and treated by his primary care. The symptoms persisted. To complicate the issue he is a military veteran who served during in the Navy from 1965-1969 on three ship exposed to asbestos and Agent Orange. I have done a lot of research on veteran connection to cancer. There is little available on Xarelto except it can cause liver damage. I am retired from being in healthcare 47 years to care for my husband. I need some help in presenting my questions to the oncologist March 1, 2016. My sincere thanks for any help you can give me.
Gratefully,
Carol [last name removed]

Reply
Tom Lamb

February 29, 2016

Thank you for your Comment.
Please understand, however, that because I am not a physician but only an attorney I am not in a position to give any medical opinion as regards your husband’s situation.
I wish your husband and you the best in all aspects going forward.
Tom Lamb

Reply
alkhat

November 12, 2018

My primary doctor discovered few problems in my liver and kidneys and asked me to see specialist, he described Xarelto for me to use for life since 4 years a go after 15 years of using comedienne or warfarin ,
My question is why the doctors don’t tell their patients that the new problems start popping up because of the medications they proscribed ?
How we as a patients can prove that ? Do you think the doctors cover each other’s backs ?
Thanks

Reply
Jessica Arseneault-Garsch

July 7, 2019

I was on xeralto for 6 years. I am a healthy young 37 year old who played two varsity sports in university. I kept saying i had pain in my liver and drs ignored me. Until this feb when i had liver enzymes so high i was about to have a liver transplant. I went off blood thinners (my own thinking) and slowing have been healing. Its been 8 weeks since and I am healing but do have scar tissue and other problems from damage to my liver.

Reply
Steve Donahue

July 27, 2019

My Dad died in 2018 due to what I think was side effect of Xarelto. He has a pacemaker put in in 2017 and was given Xarelto to thin blood. In the Spring/summer of 2018 he complained of pain in liver region went in for doc. visit and testing. Tests showed almost complete necrosis of the liver. He was scheduled for biopsy and was taken of Xarelto and had two massive strokes and died.

Reply
Teresa Beam

August 20, 2019

I am a 43 year old who had a P.E. diagnosis in 2017 and been on 20mg of Xarelto since and a few weeks ago I had an untra sound done and my liver measured 18 cm that fatty liver disease so I do believe the Xarelto caused this problem my diet is not that bad.

Reply
Aimed jones

October 3, 2019

I am 49 and have been on xarelto for a year due to a fib. I had routine labs drawn recently and everything was perfect except my alt and ast were grossly elevated. The only change in the past year were new meds xarelto And metoprolol. After researching, there seems to be a connection between hepatic function and Xarelto. I have an ultrasound next week. I am hoping it’s an easy fix such as changing anticoagulant.

Reply
Herman Beach

December 12, 2021

I am a 75 year old who was prescribed Xarelto apx. 4 years ago after my initial treatment for Atrial fibrillation. Over the past approximately 18 months my liver enzymes have climbed and I began experiencing ongoing pain in the area of my liver that has worsened over time. After being referred to various specialist and numerous blood test I have been scheduled for a liver biopsy in December 2021.
I have been a vegan for the past fifteen years. I consume no meat, dairy, alcohol, gluten or caffeine and have exercised consistently over the entire period.
Now I am concerned that I have a serious liver issue that could disable me or worse.

Reply
Harriet Millheisler

August 17, 2022

Hello Herman, I stumbled upon these comments while trying to do research on Xarelto. I was diagnosed with Afib a year ago and just had my liver enzymes checked for the first time. 234! I have alwats had a range of 10-18. I’m pretty freaked out and waiting to see my doctor next week. I’m wondering how it all turned out for you. I’ve taken myself off the Xarelto but now I’m concerned about the possibility of blood clots. Thank you, Harriet

Reply

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Xarelto: Drug-Induced Liver Injury Warning Should Be Added To Drug Label Prescribing Information For Xarelto Say Medical Researchers

Medical Journal Article Reports On Two Patients Who Experienced Severe Liver Damage Onset During Xarelto Treatment

10 responses to “Xarelto: Drug-Induced Liver Injury Warning Should Be Added To Drug Label Prescribing Information For Xarelto Say Medical Researchers”

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