Xarelto was approved by the FDA in 2009 for the prevention of blood clots in those undergoing knee or hip surgery. In 2011, Xarelto gained approval to treat those with atrial fibrillation and for stroke prevention in patients. Xarelto has also been approved to treat and reduce recurring blood clots. Johnson & Johnson, the maker of Xarelto, has spent millions of dollars touting the benefits of Xarelto while denouncing the benefits of Warfarin and Coumadin. Unfortunately, Xarelto has been tied to uncontrolled bleeding events, which can lead to hospitalization, serious injury, and even death.
There are currently more than 400 Xarelto lawsuits filed under a federal MDL, and more are expected in the coming months. If you have suffered injury after being prescribed Xarelto, and are considering filing a lawsuit, the following points could be useful:
- Xarelto inhibits the Xa direct factor which interferes with the normal blood clotting abilities of the body. Some people experience an overabundance of clotting including patients with atrial fibrillation, characterized by blood pooling in the heart and clotting. Blood clots which develop in the legs or the lungs can lead to serious complications if not treated promptly.
- The manufacturers of Xarelto are Bayer AG, Janssen and Johnson & Johnson. More than seven million people across the globe have been prescribed Xarelto.
- Unlike older blood thinners such as Warfarin and Coumadin, there is no known antidote to uncontrolled bleeding events triggered by Xarelto. If a patient experiences uncontrolled bleeding while taking Warfarin or Coumadin, Vitamin K can be administered, which will restore the body’s blood clotting. Doctors can do nothing for patients taking Xarelto who experience uncontrolled bleeding.
- Many doctors prescribe Xarelto rather than Warfarin because Xarelto does not require frequent blood testing and, according to the manufacturers, there are no known drug or food interactions.
- There are reports that another company has developed a reversal agent for Xarelto and drugs like it, however there has been no approval of the agent.
- One Xarelto study found that more than 73% of the subjects in the study developed at least one adverse side effect.
- In 2013, sales of Xarelto topped $1.4 billion, making the drug a resounding financial success for Bayer, Janssen and J & J.
- Among the lawsuits currently filed, the injuries include gastrointestinal bleeding, rectal and vaginal bleeding, brain hemorrhage, stroke, heart attack, pulmonary embolism and epidural hematoma.
- Many of these lawsuits allege the manufacturers concealed important safety information and failed to conduct adequate testing of Xarelto prior to marketing.
- There are two black box warnings on Xarelto; the first warns patients undergoing spinal procedures or receiving spinal anesthesia of the risk of paralysis and the second informs those with non-valvularatrial fibrillation that when Xarelto is abruptly discontinued, an increased risk of blood clots or stroke exists.
Xarelto Adverse Events
More than 1,800 adverse event reports have been associated with Xarelto since its release, with the most frequent issues being gastrointestinal bleeding, deep vein thrombosis, pulmonary embolisms and an increase in hematomas. During the first eight months of 2013 alone, there were 72 reports of Xarelto deaths. Despite claims to the contrary, Xarelto has been found to react adversely with anti-inflammatory medications, some herbal remedies, antivirals and antibiotics.
A report from the Institute for Safe Medication Practices identified 356 reports of serious, disabling or fatal injury associated with Xarelto. Patients who are taking Xarelto while undergoing spinal or epidural anesthesia may potentially experience paralysis. While the FDA has not require uncontrolled bleeding to be a black box warning on Xarelto, it is listed under the adverse reactions section. Those who have experienced injury after taking Xarelto should speak to an experienced Xarelto attorney to determine whether they could be eligible for compensation.
Contact Our National Dangerous Drug Lawyers
If you have suffered medical complications, pain, or excessive bleeding after using Xarelto, your injuries may be the result of a drug manufacturer's negligence. To learn more about your legal options or to schedule a free consultation call the Philadelphia class action lawyers at Golomb Legal today at 215-985-9177 or fill out our confidential contact form.