Xarelto is a drug prescribed to lower the risk of deep vein thrombosis, or blood clots that typically occur in the leg, after joint replacement surgery. Bayer is the drug manufacturer and is distributed by Johnson & Johnson, a subsidiary Janssen Pharmaceuticals.
In 2011, the Federal Drug Administration (FDA) approved Xarelto, and in 2012, the FDA approved Xarelto for a greater range of indications of deep vein thrombosis and pulmonary embolism, a condition in which a blood clot from a vein breaks off, travels to an artery in the lungs and blocks blood flow.
The FDA also approved Xarelto to reduce the risk of stroke in people with a type of irregular heartbeat called nonvalvular atrial fibrillation. This condition is present in an estimated 14 percent of the 80-and-older population.
What are the problems with Xarelto?
Bayer has been marketing Xarelto as an alternative to warfarin, a blood thinner approved by the FDA in 1954 for preventing thrombosis. All blood thinners carry a risk of excess bleeding, but warfarin patients can take Vitamin K to stanch the flow of blood. There is no known antidote for extreme bleeding in patients taking Xarelto.
Soon after Xarelto’s approval, complaints of problems as serious as death arose, and some U.S. doctors hesitated to prescribe the drug. People taking Xarelto do not need to visit the doctor frequently because of it or have their blood monitored, and some of the side effects physicians fear if patients take Xarelto incorrectly are:
These problems are of particular concern in people with impaired kidney function.
Reports of adverse effects to the FDA bore fears out. In 2012, its first full year on the market, Xarelto gave rise to 2,081 reports of “serious, disabling and fatal” incidents, including 151 deaths, according to the Institute for Safe Medication Practices. Reviewing the data from 2013, the institute found reports of adverse effects were rising, with the FDA having received 680 reports in the first quarter of the year alone.
Bayer and Janssen face lawsuits over Xarelto
Know that legal action over is Xarelto is not unprecedented. Nearly two dozen lawsuits have been filed in federal court saying Bayer and Janssen knew or should have known of the risks of severe internal bleeding related to Xarelto, but did not tell people about them. These suits have come on top of litigation filed in state courts.
Complications that occurred due to serious bleeding among the Xarelto patients involved in the lawsuits have included multiple deaths, brain hemorrhaging and severe, permanent injuries.
The FDA seemed to take notice of these tragedies. Every member rejected the use of Xarelto for treatment of patients with acute coronary syndrome, in which sudden reduced blood flow to the heart causes heart attacks and chest pain. The agency, making its third decision against Bayer over expanded use of Xarelto, even said the some data from Bayer’s clinical trial was missing.
What should you do?
If you or someone you know on Xarelto has experienced gastrointestinal bleeding, hemorrhaging, stroke or death, you should immediately contact the attorneys at Hodes Milman Liebeck, LLP to find out about your rights. It is important your matter is immediately investigated.
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