What is Xarelto?

Xarelto (Rivaroxaban) is a relatively new anticoagulant (blood thinner). The FDA first approved Xarelto in 2011. It is distributed in the United States by Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer Healthcare. Xarelto was released as a replacement for Coumadin (Warfarin), a blood thinner effectively used for decades.

Xarelto is used to treat or prevent deep vein thrombosis which can lead to blood clots in the lungs (pulmonary embolism). It is also used to treat atrial fibrillation (heart rhythm disorder) to lower the risk of stroke due a blood clot. A Huffington Post article in 2012 detailed concerns of top heart doctors related to new blood thinners Xarelto and Pradaxa.

Were the Clinical Trials Tainted?

Slate article asks the important question — Are Your Medications Safe? It’s a question I’ve raised about several drugs and medical devices allowed by the FDA. According to Slate:

We didn’t have to search very hard to find FDA burying evidence of research misconduct.

The Slate article details two large clinical trials used to support FDA approval of Xarelto. According to the article, the studies were tainted by falsified data and the discarding of medical records.

What Problems Are Potentially Related to Xarelto?

Since its inception, Xarelto has been the subject of many adverse event reports to the FDA. Numerous claims have been filed as a result of personal injuries and deaths by patients taking the medication. Primary problems associated with the medication are:

  • Deaths Due To Uncontrolled Bleeding
  • Gastrointestinal Bleeding
  • Hemorrhaging
  • Strokes

Our FDA should protect patients from dangerous drugs and defective medical devices. Too often it does not. It’s all too common for dangerous and defective drugs to be approved for use. I’ve written past posts about the failed FDA approval process as well as research bias for drugs and medical devices. We are investigating Xarelto and potential injuries or deaths from it. In the future, the FDA should act first so needless injuries and deaths can be prevented.