If you have questions regarding the risks vs effectiveness of Xarelto, reach out to an experienced injury attorney to learn more about the case history regarding this drug. Since its introduction to the market, there have been hundreds of lawsuits filed by patients or their families because they suffered severe or fatal internal bleeding while on Xarelto. Read on to learn more about the risks vs effectiveness of Xarelto, as well as the ways a professional lawyer could potentially make a difference in your life.
In July 2011, the Food and Drug Administration granted approval to Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, for production of Xarelto. Janssen touted the drug, an anticoagulant, as an effective treatment for deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as a way to reduce the recurrence of these conditions.
However, during the application process, medical professionals from the FDA declined to recommend the approval of the drug, citing concerns about how effective the drug actually was compared to other available working medications. Despite these concerns, the FDA approved Xarelto. Four months later, in November 2011, the FDA extended its approval to allow Janssen to market Xarelto as a way to reduce stroke risks for patients suffering from atrial fibrillation.
Since 2011, the FDA has issued multiple warning about the possible dangers associated with Xarelto, and has also required the company to include the government’s most serious type of advisory—the black box warning—to its packaging and marketing to address Xarelto’s many dangerous risks.
The FDA also raised questions about one of the clinical trials Janssen provided to the agency in its quest for approval. Specifically, the company used a questionable device to measure a competitor’s product when testing for effectiveness of stroke prevention. Previously, that device had been the subject of two warning letters from the FDA regarding inaccurate readings, and the device was subsequently recalled. The drug in question was one of the drugs that the FDA’s medical experts had cited as being more effective than Xarelto.
In October 2017, Janssen announced they were stopping another clinical study which was addressing the safety and effectiveness of Xarelto for stroke and systemic embolism prevention. The early results revealed that Xarelto had little chance of showing overall benefit compared to treatment with low-dose aspirin.
If you suffered internal bleeding after being prescribed Xarelto, contact a dangerous drug attorney to discuss what civil options may be available to you. Your attorney could go over all the details of your case, including the extent of the injury you suffered, any long-lasting or permanent damage, and the amount of pain the injury caused or continues to cause. Your medical expenses, loss of income, and any other losses could help determine what financial compensation you may be entitled to. Because of this drug. If you have more inquiries regarding the risks vs effectiveness of Xarelto, reach out to an experienced lawyer today to learn more.
Charles E. Boyk Law Offices, LLC