Xarelto® Lawsuit Update: Bayer/Johnson & Johnson Plan to Further Expand Indications for Xarelto®
Yahoo! Finance reports that Bayer and its partner Johnson & Johnson plan to potentially expand Xarelto®’s use for the prevention of potentially deadly blood clots in patients at risk of arterial thromboembolism. The companies plan to evaluate Xarelto® for such a new indication in three clinical studies: (1) In a global phase III study (NAVIGATE ESUS), Xarelto® will be evaluated in patients suffering from embolic stroke of undetermined source; (2) In another phase III study (VOYAGER PAD), Xarelto® will be studied within the context of reducing thrombotic vascular complications in patients suffering from peripheral artery disease undergoing peripheral artery interventions; (3) In the phase II study (GEMINI ACS 1), Xarelto® will be studied for long-term prevention in patients who have suffered an acute coronary syndrome.
The anti-clotting medication Xarelto®, which is marketed by Johnson & Johnson in the United States and by Bayer outside the United States, was approved by the Food and Drug Administration (FDA) in July 2011 for use in patients who recently underwent hip or knee replacement surgery to reduce the risk of blood clots. According to a press release issued by the FDA, in November 2011 the FDA approved another indication of Xarelto® for patients with atrial fibrillation (AF) to reduce the risk of stroke. Then in 2012, the FDA notes that the use of Xarelto® was again expanded for the general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
According to Bloomberg, earlier this year Johnson & Johnson and Bayer AG failed to win approval for expanded use of Xarelto® from the U.S. Food and Drug Administration (FDA). Johnson & Johnson sought expanded approval to prevent heart attacks and strokes 90 days after patients experience serious chest pain or cardiac illnesses, a condition referred to as acute coronary syndrome. The FDA determined that the effectiveness of the drug was not strong enough to outweigh the serious risk of bleeding, which increases the longer the patient ingests the drug. This denial by the FDA comes after recent reports on the drug’s adverse events, including serious and uncontrolled bleeding.
According to the Institute for Safe Medication Practices’ (ISMP) most recent Quarter Watch Report compiling data from 2013, Xarelto® (rivaroxaban) has overtaken Pradaxa® (dabigatran) in the number of reported adverse events, including serious bleeding events. The ISMP QuarterWatch reports that in 2013, the U.S. Food and Drug Administration (FDA) reported receiving 680 serious adverse event reports from individuals who alleged to have suffered adverse events while taking the anticoagulant drug Xarelto® (rivaroxaban), while only 528 serious adverse events were reported for Pradaxa® (dabigatran). The FDA’s Adverse Event Reporting System (FAERS) remains the cornerstone of postmarket safety surveillance, the mechanism through which most significant drug risks are detected once a drug has been approved and is available on the market.
If you or a loved one has suffered serious injuries after using Xarelto®, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.
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