Xarelto® Lawsuit Update: Bayer & Johnson & Johnson Aim to Expand Uses for Xarelto
The Wall Street Journal reports that Johnson & Johnson and Bayer AG recently announced plans to launch clinical trials of Xarelto® against new diseases in order to double the number of indications and widen the market for Xarelto®, which is already poised to exceed $1 billion in sales for 2014.
In particular, 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).
The ISMP 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). The FDA’s Adverse Event Reporting System (FAERS) remains the cornerstone of post-market safety surveillance, the mechanism through which most significant drug risks are detected once a drug has been approved and is available on the market. A new study published in the August issue of the Journal of Neurosurgery found that internal bleeding associated with certain anticoagulants – including Xarelto® – is more difficult to stop in comparison to other blood thinning medications. The study discussed new guidelines on how to treat uncontrolled bleeding in the brain and pointed out that surgeons are faced with an extreme difficulty of treating brain hemorrhage patients who are taking certain direct Factor Xa inhibitor anticoagulant medications, such as Xarelto®. The study authors emphasize that when a patient suffers a bleed while taking warfarin, another blood thinning medication, the bleeding can be reversed by quickly administering vitamin K; however, direct Factor Xa inhibitors – such as Xarelto® – are within a newer class of anticoagulants that do not have a reversal agent.
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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