Xarelto Bleeding Risks

Am I at risk for dangerous bleeding if I take Xarelto?

Some users have had uncontrolled bleeding when using the anti-coagulant drug Xarelto (rivaroxaban).

Xarelto is a blood thinner used to reduce the risk for blood clots. It is given to people who have had hip or knee replacement surgery. After these surgeries, there is a higher risk for health problems related to blood clots. The drug is also used by people at risk for stroke.

About Xarelto

Xarelto is made by Bayer and sold in the United States by Janssen, a partner of drug giant Johnson & Johnson.

The drug works by blocking the process the body uses to make blood clot and stop bleeding. All patients are given the same dosage of Xarelto, no matter their differences in weight and health needs. There is also no antidote for Xarelto, which means users can have severe bleeding events for which there is no cure. Older anti-clotting drugs like warfarin do have an antidote and are given in patient-specific doses.

Bleeding Risks and Xarelto

It’s possible for someone to be given too much Xarelto or for another event to trigger an uncontrolled bleeding event. When this occurs, patients must wait at least 24 hours after their last dose for the drug to be flushed from their body. It’s possible that a bleeding event lasting this long could be fatal.

Users of Xarelto do not need to undergo testing, which means there are no regular check-ins with doctors. If there is a problem with the drug, a great deal of time could pass before the issue is brought to a doctor’s attention.

Xarelto puts users at risk for serious internal bleeding. If you are taking Xarelto, you should be aware of the symptoms of internal bleeding, which include:

  • Fatigue
  • Blood in stool
  • Easy bruising
  • Pale skin
  • Low blood cell count
  • Swelling in the stomach area
  • Dizzy feeling
  • “Stroke-like” symptoms

It is possible to have a bleeding event without any symptoms. Users of this drug should report anything strange to their doctor as soon as something is noticed.

FDA’s Stand on Xarelto

The US Food and Drug Administration (FDA) received nearly 700 adverse event reports during the first three months of 2013. Some of the events were fatal.

As a result of the dangers of Xarelto, the FDA forced the drug’s maker to include a black box warning on the package. This warning also addressed the danger of stopping Xarelto use and about the drug’s potential to cause a blood pool following an epidural or spinal surgery. This can lead to long-term or permanent disability.

Other than bleeding events and other black box-level side effects, Xarelto can also trigger a number of mild to moderate side effects, such as:

  • Low blood pressure
  • Headache
  • Muscle plain
  • Nausea and vomiting
  • Nose bleeding
  • Swelling

Xarelto Dose Information Wrong

In June 2014, Janssen Pharmaceuticals was forced to alert doctors that the website had wrong information. The information was related to the dosage amount of the drug.

Xarelto Lawsuits

The first Xarelto lawsuits filed against Bayer were made public in June of 2014. There were nine claims filed after users had bleeding events. Adverse events linked to Xarelto might happen at a rate of two thousand per year.

One of the original lawsuits filed against makers of Xarelto was from a Vermont family who lost a loved one to an uncontrolled brain hemorrhage after using Xarelto for only 10 days. The family claims Xarelto makers were aware of the risks and the lack of antidote for bleeding events, but failed to warn doctors and consumers.

If you or a loved one suffered a bleeding event or other side effect after taking Xarelto, you might be able to get money to pay for your medical costs.

View Sources

  1. Chang, P. (June 2014) Healthcare professionals letter: Correction of Dosing Information for Xarelto Tablets, Janssen Pharmaceuticals, Accessed on 01 August 2014, www.xareltohcp.com/sites/default/files/pdf/HCP-Dosing-Correction-Letter.pdf
  2. Food and Drug Administration (01 July 2011) FDA Approves Xarelto (rivaroxaban) to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery. [Press release] U.S. Food and Drug Administration.. Accessed on 01 August 2014 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261839.htm
  3. Food and Drug Administration (04 November 2011). FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm [Press release] U.S. Food and Drug Administration.. Accessed on 01 August 2014 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278646.htm
  4. Food and Drug Administration (02 November 2012). FDA expands use of Xarelto to treat, reduce recurrence of blood clots. [Press release] U.S. Food and Drug Administration.. Accessed on 01 August 2014 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm326654.htm
  5. Institute for Safe Medicine Practices, (May 2014) QuarterWatch 2013 Q1, ISMP, Accessed on 01 August 2014, http://www.ismp.org/quarterwatch/
  6. Pierson, R. (14 June 2012) Insight: Top heart doctors fret over new blood thinners. Reuters. Accessed on 01 August 2014 http://www.reuters.com/article/2012/06/14/us-drugs-bloodthinners-idUSBRE85D06G20120614
  7. Palmer, E. (16 June 2014) Sources: Bayer, J&J’s Xarelto faces first U.S. lawsuits, FiercePharma, Accessed on 01 August 2014 http://www.fiercepharma.com/story/sources-bayer-jjs-xarelto-faces-first-us-lawsuits/2014-06-16
  8. PR Web, (27 July 2014) Xarelto Lawsuit News: Report Finds Adverse Events For Xarelto Bleeding Side-Effects Outnumber Those For Pradaxa, Accessed on 01 August 2014 http://www.12newsnow.com/story/26122518/xarelto-lawsuit-news-report-finds-adverse-events-for-xarelto-bleeding-side-effects-outnumber-those-for-pradaxa
  9. PRWeb.com, (30 July 2014),Xarelto Lawsuit Alleges Man’s Death from Uncontrollable Brain Bleeding Was Caused by Xarelto, Digital Journal, Accessed on 01 August 2014 http://www.digitaljournal.com/pr/2090599
  10. Reuters (14 June 2014)Bayer faces law suits in United States over Xarelto: paper, Reuters Frankfurt, Accessed on 01 August 2014 http://www.reuters.com/article/2014/06/14/us-bayer-suit-idUSKBN0EP0HW20140614
  11. Xarelto Consumer Information (2014). Janssen Pharmaceuticals, Accessed on 01 August 2014 https://www.xarelto-us.com/
  12. Xarelto Professionals (2014), Janssen Pharmaceuticals, Accessed on 01 August 2014, http://www.xareltohcp.com/
  13. Xarelto Prescribing Information, (2014), Janssen Pharmaceuticals, Accessed on 01 August 2014 www.xareltohcp.com/prescribing-information.pdf
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