Invented and manufactured by the pharmaceutical giant Bayer, Xarelto is an oral anticoagulant designed to prevent blood clots by inhibiting factor Xa. It is marketed by Janssen Pharmaceutical as Xarelto, and it is the first orally active direct factor Xa inhibitor.
On July 1, 2011, the FDA approved the use of Xarelto for prophylaxis of deep vein thrombosis (DVT) in adults having knee or hip replacement surgery. In November of the same year, the FDA also approved Xarelto for stroke prophylaxis in certain patients.
Researchers quickly discovered one of the most serious adverse effects of Xarelto: internal bleeding. Although this is a common side effect of anticoagulant medications, Xarelto poses a more serious threat, because there is currently no antidote that can reverse its blood-thinning effects. In an emergency situation, patients can be at risk of irreversible bleeding complications that can be life-threatening.
According to a document compiled by the Institute for Safe Medication Practices, 356 reports of "serious, disabling, or fatal injuries" as a result of Xarelto were filed to the FDA in the first quarter of 2012 alone. In an ironic twist, this same document noted that one of the most common side effects of Xarelto was pulmonary embolism; a blockage problem that the medication is actually designed to treat and prevent! Most of the patients who suffered a pulmonary embolism had only taken the drug for short-term, post-surgery treatment.
Although the exact number of lawsuits filed against Janssen Pharmaceutical and Bayer Healthcare is unknown, the charges raised include the following:
- Janssen and Bayer failed to properly warn patients of the risk of dangerous and potentially life-threatening internal bleeding when taking Xarelto.
- The makers of Xarelto did not advise medical professionals on how to act and stabilize patients in the event of bleeding.
- Janssen and Bayer marketed the medication as a superior alternative to warfarin, despite having knowledge that Xarelto caused more frequent instances of gastrointestinal bleeding and transfusions than its competitors.
- The manufacturers of the drug exhibited bias for maximizing profits rather than minimizing the dangerous effects of the drug.
For more information regarding the harm of Xarelto, download a copy of our free E-book, The Xarelto Disaster: How Johnson & Johnson Failed to Warn Consumers of Deadly Internal Bleeding Risks or call our experienced legal team to discuss your particular issue with Xarelto by calling 855-423-3666.