The famous blood thinner Xarelto has been targeted with increased critical observation over the past several years. It was approved by the U.S. Food and Drug Administration in 2011 for the prevention of blood clots and deep vein thrombosis in patients undergoing knee and hip replacements, atrial fibrillation, patients with acute coronary syndrome. The drug is generally prescribed as an alternative to Warfarin (coumadin), a blood thinner that began to be used in 1954. The most serious potential side effects, complications and risks caused by Xarelto are severe internal bleeding, hemorrhaging and wrongful death, with no antidote available for doctors to control Xarelto bleeding events.
A woman from Florida filed a lawsuit against Johnson & Johnson (J&J) subsidiary, Janssen Pharmaceuticals. The lawsuit was filed on behalf of her deceased husband in United States District court for Florida. As per the plaintiff her husband suffered from a condition called Atrial Fibrillation (AFib), which is an irregular heartbeat. Patients with Atrial Fibrillation are at an increased risk of suffering from a stroke, so he was prescribed Xarelto to lower the risk. Subsequently he was presented to the emergency department with a pronounced subdural hemorrhage – between the brain and its outermost covering. He was immediately admitted to the Intensive Care Unit, and was thereafter transferred to a skilled nursing facility while recovering from the sudden onset of brain bleeding. Despite medical interventions, the decedent passed.
The Florida couple is not only suffering from the life threatening side effects of Xarelto, more than 7,000 Xarelto lawsuit alleging similar xarelto claim are currently pending against the company. Plaintiffs allege that there is no antidote to stop uncontrolled bleeding, which can lead Xarelto to cause someone to bleed to death. Anticoagulation is needed due to life-threatening or uncontrolled bleeding cause by the drugs. A major reason for the increased risk of bleeding to death on Xarelto appears to be linked to the lack of an approved reversal agent, as there is no safe and effective antidote available that doctors can use to quickly stop hemorrhaging that may develop. The only antidote made was recently rejected by the US Food and Drug Administration (FDA).
Earlier this year, in February 2016, researchers from the Duke Institute have performed the ROCKET-AF trial, provided a new in-depth analysis of the new blood thinner’s efficacy and safety outcomes after five years of use. The test results reveal that the previous findings of rivaroxaban superiority over Warfarin were false. The Duke researchers were hiding valuable information as they were conspirator with Bayer and J&J. According to the studies done by researchers, the drug makers may have reduced the risk of patients dying on Xarelto uncontrollable bleeding if they had provided stronger warnings and recommended blood monitoring during treatment.
Xarelto received two black box warnings from the FDA. These warnings are the strictest warning a product can receive before being pulled completely from the market. The most serious potential xaretlo side effects, complication and risk caused by Xarelto are severe internal bleeding that can result in death. Plaintiffs like the Florida woman will have to wait just a little longer for their day in court with the drug manufacturer. Bellwether trials are scheduled to begin in early 2017. The manufacturers placed their desire for profits before consumer safety by failing to fully explore all potential reversal agents before introducing the medication.