In July of 2011, Bayer, in conjunction with Janssen Pharmaceuticals, began marketing Xarelto, a prescription anticoagulant (often called a blood thinner) used to prevent blood clots. Blood clots have the ability to prevent blood flow to patients’ organs such as the heart, lungs, and kidneys. Xarelto was initially approved by the FDA for prevention of deep vein thrombosis following knee and hip surgeries. Further approval was given in November of 2011 for the prevention of stroke in patients with atrial fibrillation, and later in 2012 for prophylactic prevention of reoccurring clots.
Uses and Effects
Bayer and Janssen have marketed Xarelto as a more convenient alternative to Warfarin, the industry standard for the past 60 years. Whereas Warfarin patients must observe a strict diet regimen and submit to frequent blood tests, Xarelto is promoted as the only once a day blood thinner with no dietary restrictions and no blood monitoring. However, there is also no antidote for Xarelto, while there is an antidote for Warfarin. As a result, internal bleeding in patients taking Xarelto cannot be controlled. Bayer and Janssen were cited by the FDA in June of 2013 for “misleadingly minimiz[ing] the risks associated with Xarelto.” Click here to view the letter.
In May of 2013, the Institute for Safe Medication Practices released a report stating that Xarelto had surpassed market competitor Pradaxa in the number of serious adverse events associated with the drug, making it the most dangerous drug in the Anticoagulant market. Hundreds of the adverse events associated with the consumption of Xarelto have involved bleeding in the form of brain hemorrhaging, rectal bleeding, intestinal bleeding, and death caused by the former. Further, in 2012, FDA reports showed that in comparison with those of Warfarin, adverse effects of Xarelto resulted in three times as many deaths.
As a result of these serious adverse events, many lawsuits have been filed against both Bayer and Jansen Pharmaceuticals claiming that the companies were negligent in providing accurate information about the serious side effects of the drug. This negligence also pertains to the marketing of the drug as patients and their families maintain they were not adequately warned of the medication’s risks. The lawsuits depict a range of serious adverse events leading to wrongful death and injury, including instances of brain hemorrhaging after use of the medication for only one month. Families of deceased patients seek restitution for financial and emotional hardship, loss and distress, as well as the burden of lost wages and funeral expenses for loved ones. They maintain that Janssen Pharmaceuticals and Bayer should have been more vigilant in testing Xarelto and that the companies should be held accountable for introducing a dangerous drug to the market.
If you or a loved one were prescribed the blood thinner Xarelto® and have suffered a serious bleeding complication, you may be able to seek compensation. The Law Offices of Peter Angelos, P.C. is currently reviewing claims of internal bleeding in regards to a potential Xarelto® lawsuit. Contact our attorneys for a no charge consultation.