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FDA Asks If Faulty Blood Monitor Tainted Xarelto Approval

Posted on May 12, 2016

The U.S. Food and Drug Administration (FDA) has launched an investigation into whether a faulty blood monitor used in clinical trials lead to the approval of a widely prescribed anticoagulant medication. Xarelto (rivaroxaban), Johnson and Johnson’s popular blood thinning medication, was designed to compete with the long used warfarin, an anti clotting drug that has been in use for over 60 years. Anticoagulants are used to prevent blood clots, such as deep vein thrombosis and pulmonary embolism, strokes, and to treat atrial fibrillation, a heart rhythm disorder. What many patients don’t like about warfarin is that it requires adherence to a strict diet and constant blood monitoring. Xarelto, on the other hand, doesn’t have dietary restrictions or require blood monitoring.

Xarelto’s safety and effectiveness were tested in medical studies several times between 2006 and 2010, in a study involving over 14,000 patients. Rates of blood clots and strokes in patients taking Xarelto were compared to those patients being treated with warfarin. Those being treated with Xarelto had their blood monitored with a device known as an INRatio to determine whether or not they were getting the proper dosage. In 2014, after the FDA approved Xarelto, Alere (the company that manufactured the INRatio) recalled the blood monitoring device because they determined it routinely gave inaccurate readings. The FDA now wonders if the Xarelto patients may have had a higher incidence of blood clots and strokes because they weren’t getting the proper amount of their medication. This is just one more problem that Xarelto has faced. Dangerous side effects such as excessive bleeding have also plagued the medication.

If you or a family member has suffered side effects while being treated with Xarelto, you may be able to pursue compensation for your injuries. A dedicated pharmaceutical liability attorney can help. Farah & Farah is currently investigating injuries related to Xarelto use nationwide. Call us at (800) 533-3555 today, for a free consultation.