FDA Delays Xarelto Antidote

Xarelto is a popular anticoagulant (blood thinner) used by thousands of patients at risk of blood clots, atrial fibrillation, and stroke. Marketed as a lower-maintenance alternative to predecessor Coumadin, the relatively new drug grew quickly in popularity. Although Xarelto doesn’t require the regular patient monitoring required by Coumadin, it does have at least one significant drawback – there is no antidote to hemorrhaging or excessive bleeding caused by Xarelto. To be fair, this is much more than a drawback; patients have died.

More than 7,000 lawsuits directed at Xarelto manufacturer, Janssen Pharmaceuticals, have been reported as of this date. Many of these lawsuits claim harm due to uncontrolled bleeding following Xarelto use and failure to warn patients of life-threatening side effects. All anticoagulants have a risk of excessive bleeding. But there’s one major difference. Excessive bleeding linked to Coumadin can be stopped. If a patient begins to hemorrhage after being treated with Coumadin, the bleeding can be halted with relative ease by administering an antidote. Basically, the patient is injected with a combination of vitamin K and fresh blood plasma to reverse excessive bleeding. No such antidote exists for Xarelto.

The first Xarelto-related lawsuit was a wrongful death suit filed against Janssen Pharmaceuticals in 2014. Since then, thousands more have joined, resulting in the formation of a Xarelto multidistrict litigation (MDL). Massachusetts Xarelto patients who have experienced uncontrolled bleeding after using the drug should contact a MA drug injury lawyer today.

Xarelto Patients Twice as Likely to Suffer from Stomach Bleeding

In response, Portola Pharmaceuticals has manufactured a possible antidote called AndexXa. However, the FDA has requested more information before it will allow AndexXa to be released to the public. It may be wise of the FDA to prevent AndexXa’s release until they are sure it is safe, but physicians and patients hope a safe option hits the shelves soon. Too many patients have been seriously injured, or have died, as a result of Xarelto use. In fact, studies show that patients taking Xarelto have double the risk of developing stomach bleeding as patients taking a different medication.

Potentially Life-Threatening Risks Linked Associated with Xarelto

Xarelto isn’t the only drug of its type linked to these serious health complications. Pradaxa and Eliquis, two newer drugs belonging to the same category, also have no antidote. Risks associated with Xarelto, Pradaxa and Eliquis include:

  • Internal bleeding
  • Hemorrhage of the brain
  • Rectal Bleeding
  • Ischemic Stroke
  • Embolism
  • Death

Lawsuits allege that Janssen knew about the risks associated with its drug but failed to adequately warn patients and physicians. They also claim the manufacturer continued to market Xarelto even though they knew it was unsafe. If you have been harmed due to the use of any of the above mentioned anticoagulant drugs, contact a Boston Drug Injury Lawyer Today.

Altman & Altman, LLP – Drug Injury Lawyers Serving All of Massachusetts for More than 50 Years

If you have been injured due to the negligence of a pharmaceutical company, we can help. When big drug companies put profits above the safety and wellbeing of the general public, we believe they should be held accountable for their actions. You may be entitled to compensation for your pain and suffering, medical expenses, lost wages, and other associated costs. At Altman & Altman, LLP, our attorneys are as skilled as we are compassionate. We will fight tirelessly to get you the compensation you deserve so that you can get on with your life. Contact Altman & Altman, LLP today for a free and confidential consultation about your case.


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