December 11, 2015
December 11, 2015 - PRESSADVANTAGE -
Hundreds of patients or their families have filed lawsuits against the makers of Xarelto after suffering severe, and sometimes fatal, bleeding. Plaintiffs claim that Xarelto manufacturers Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and Bayer did not provide adequate warnings concerning the risk of uncontrolled bleeding, and may have put thousands of people at risk.
In 2011, US Food and Drugs Administration (FDA) approved Xarelto to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism in patients undergoing knee or hip replacement surgery, but also to reduce the risk of stroke in patients with irregular heartbeat called atrial fibrillation.
Xarelto is a new type of anticoagulant – a medication that prevents blood from clotting. Blood clots that form inside veins or arteries may be dangerous, especially when they travel to the heart, lungs, or brain. For patients with a high risk of blood clots, treatment with blood thinners may be appropriate. Unfortunately, blood thinners can have serious side effects. Too high doses put patients at risk of bleeding to death. While the older blood thinners have antidotes or they can be removed from the blood by dialysis, Xarelto has no antidote and is not affected by dialysis. Therefore, bleeding can not be controlled and may be fatal for patients who take Xarelto.
In 2013, the FDA issued a warning letter (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM357833.pdf) to Janssen Pharmaceuticals stating that a print advertisement for Xarelto is false because it minimizes the risks associated with the drug and makes a misleading claim suggesting that dosage adjustments are not necessary with Xarelto. Now, more and more patients injured by Xarelto side effects are filing lawsuits. Victims of Xarelto say they were not adequately warned about the risk of side effects, nor about the fact that Xarelto does not have an antidote and can cause uncontrolled bleeding.
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