Doctors prescribe Bayer’s billion-dollar blood thinner Xarelto to prevent blood clots and protect patients from strokes, deep vein thrombosis and pulmonary embolism. Xarelto may cause irreversible internal bleeding that can lead to hospitalization and death.
Institute of Safe Medication Practices Report
The Institute of Safe Medication Practices (ISMP) noted that the number of serious adverse events with Xarelto bleeding side-effects is significant and worse that for another new blood thinner, Pradaxa.
Xarelto prescriptions increased to nearly 1 million prescriptions per quarter, according to ISMP. ISMP monitors and analyzes serious adverse drug events reported to the U.S. Food & Drug Administration (FDA).
Xarelto Increasing Adverse Reports
As the usage of Xarelto increases in the United States, many Xarelto uncontrollable bleeding lawsuits are being filed against Bayer AG, the Germany-based company which manufacturers Xarelto.
In the first quarter of 2013, ISMP found 680 serious adverse event reports associated with rivaroxaban, the generic name for Xarelto, compared to 528 complaints for dabigatran, the generic name for Pradaxa.
The ISMP suggests that the trend is mostly due to doctors changing prescriptions for their patients from Pradaxa to Xarelto.
Xarelto and Pradaxa No Antidote
Xarelto and Pradaxa are both newer blood thinners compared to warfarin, a blood thinner approved by the FDA in 1954 and marketed under the brand names of Coumadin.
There is no approved antidote for oral anticoagulants, such as Xarelto and Pradaxa, if significant bleeding should occur in patients taking the blood thinners.
Xarelto was initially approved by the FDA in July 2011 to reduce deep vein thrombosis and pulmonary embolism in patients who had knee or hip replacement surgery.
Xarelto use was expanded in November 2011 to reduce stroke and blood clot risks in patients with atrial fibrillation (irregular heart rhythms).
Xarelto received FDA approval again in November 2013 to treat deep vein thrombosis. According to Dr. Ellis Unger, a director in the FDAs Center for Drug Evaluation and Research, In contrast, Dr. Unger said that vitamin K is a reversal agent for people taking warfarin.
Xarelto Lawsuit Due to Subdural Hemorrhage
A Florida woman filed a Xarelto side effects lawsuit in June that alleges her husband died after suffering a subdural hemorrhage. According to the Xarelto lawsuit, the womans husband was prescribed Xarelto in January 2012 to treat atrial fibrillation and suffered the subdural hemorrhage in June 2013.
The Xarelto lawsuit states that he died five days later, despite medical treatment. According to the complaint the defendants, Janssen Research & Development and Bayer, concealed their knowledge to patients and the doctors that Xarelto allegedly causes deadly irreversible bleeds.
UPDATE: Xarelto Wrongful Death Lawsuit Filed in New York
August 21, 2014 — A Wrongful Death lawsuit has been filed against Janssen Pharmaceuticals and Bayer alleging that Xarelto caused a 92 year-old man to bleed to death.
August 12, 2014 — A lawsuit has been filed in federal court in New York by a Texas woman who developed severe bleeding after taking Xarelto for a few months.
July 29, 2014 — A Wrongful Death lawsuit has been filed by a Vermont man who died of uncontrollable bleeding in his brain after taking Xarelto.
June 26, 2014 — A Wrongful Death lawsuit has been filed on behalf of a man who took Xarelto for atrial fibrillation and died six month later from uncontrollable bleeding in the brain.
June 17, 2014 – The Frankfurter Allgemeine Zeitung, a newspaper in Germany, cited company sources as saying there were fewer than 10 lawsuits pending against Bayer. Bayer declined to comment except to say that Xarelto’s safety profile is consistent with clinical trials involving more than 75,000 patients.
May 7, 2014 – A Wrongful Death lawsuit has been filed in Pennsylvania by a woman who died after taking Xarelto.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.