Ford & Associates Nationwide Legal Services, A.P.C., Comments on Xarelto Lawsuits Upon FDA Revisions
San Diego, CA (PRWEB) March 02, 2015 -- In light of the FDA's approved revisions to the safety label of anticoagulant Xarelto (rivaroxaban) tablets, Ford & Associates Nationwide Legal Services notes that these cautionary revisions may be helpful for future users, but may come too late for individuals who have already allegedly suffered injuries from taking the drug. The FDA has now included the term “thrombocytopenia,” a low blood platelet disorder, under Adverse Reactions on Xarelto's label. The term “cytolytic hepatitis” has also been replaced with “hepatitis (including hepatocellular injury).” *
Lawsuits against Xarelto allege that Janssen Pharmaceuticals, Inc., the manufacturer of Xarelto, knew of the possibility of internal bleeding and other Xarelto side effects, but didn't adequately warn of such events. According to case documents, individuals who took Xarelto have allegedly experienced severe bleeding, strokes, and fatal injuries leading to death.
“We acknowledge the FDA's Adverse Reactions revisions to Xarelto's labeling, and are interested in talking with people who took Xarelto prior to these revisions, and may have suffered injuries as a result. We are committed to helping people find the best legal representation possible, and encourage them to contact us.” – Mateo Martinez, Ford & Associates Case Manager
Xarelto (rivaroxaban) was on FDA’s 2011 Innovative Drug Approval List as a new anticoagulant used to prevent the formation of blood clots in patients who suffer from deep vein thrombosis (DVT), atrial fibrillation (irregular heart rhythms), pulmonary embolism (PE), and are at high risk of stroke. Xarelto is marketed as superior and easier to use than other anticoagulants, as the drug doesn't require dietary restriction, or tests to monitor the patients’ blood plasma levels.**
Although the FDA notes that Xarelto doesn't at present have an antidote to stop severe bleeding if it should occur, Ford & Associates has learned of studies, as reported by Reuters, that an intravenous antidote, andexanet alfa, has been developed, and is being tested for accuracy to reverse the anticoagulation activity associated with Xarelto use. Current trial data indicates that the Portola Pharmaceuticals anti-clotting drug has already experienced a high success rate of reversing internal bleeding associated with Xarelto in healthy patients aged 50-75. More testing details are suspected to be released within the coming year.***
Ford & Associates also comments that there are currently 21 Xarelto lawsuits filed and pending against the manufacturers of Xarelto (Case MDL No. 2592). In December of 2014, the U.S. Judicial Panel on Multidistrict Litigation centralized all federally-filed Xarelto lawsuits to the U.S. District Court, Eastern District of Louisiana. The U.S. Judicial Panel stated there were common issues in all Xarelto cases that allowed for centralization, such as “the adequacy of Xarelto’s warning label with respect to the risk of severe bleeding and other injuries, the results of certain clinical studies, and the alleged need for blood monitoring.” (Case MDL No. 2592).
*fda.gov/Safety/MedWatch/SafetyInformation/ucm367392.htm, FDA, December 2014
** fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM278358.pdf, FDA, February 2011
*** reuters.com/article/2015/01/09/us-portola-pharma-study-idUSKBN0KI1DR20150109, Reuters, January 2015
About Ford & Associates Nationwide Legal Services, A.P.C.
Ford & Associates Nationwide Legal Services, A.P.C., is a San Diego based law firm that fights aggressively for the rights of those who cannot fight for themselves. Each case is treated with unparalleled dedication, compassion, and skill, and pursued to the fullest extent as allowed by law until a favorable outcome has been reached.
If you or a loved one believe that you have suffered adverse health conditions from using Xarelto, and are seeking answers to Xarelto lawsuit and/or rivaroxaban lawsuit questions, contact Ford & Associates today at 1-866-242-0905 for a free, no-obligation case review.
Ford & Associates Nationwide Legal Services, A.P.C.
3555 4th Ave
San Diego, CA 92103
866-242-0905
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Contact Information:
Mateo Martinez, Case Manager
Ford & Associates Nationwide Legal Services, A.P.C.
3555 4th Ave
San Diego, CA 92103
866-242-0905
drug-lawsuits.com
Mateo Martinez, Ford & Associates Nationwide Legal Services, A.P.C., http://drug-lawsuits.com, +1 866-242-0905, [email protected]
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