blood test during approval process for xarelto

FDA Still Stands Behind Xarelto Approval After Review

Since 2014, many have questioned if the Food & Drug Administration (FDA) made a good decision when they approved the blood thinner Xarelto. So many in fact, that the FDA reviewed the study which resulted in the approval.


Known at the FDA as Rocket-AF, the study specifically addressed if the blood thinner was a safe and blood test during approval process for xareltoeffective treatment for patients suffering from atrial fibrillation. Throughout the study, the device used to monitor the clotting properties in the blood was the Alere Inc INRatio device – a machine that was later found to give faulty results.

On October 11th, 2016, the FDA announced that despite the issues with the device, they believe that the results of the study were still accurate. This announcement has frustrated the thousands of plaintiffs involved in the ongoing litigation against the manufacturers.

Why Are Lawsuits Being Filed Against The Manufacturers?

Xarelto, which was first approved in 2011, was initially named a “wonder drug” by the medical community. Prior to its release, most patients with a clotting disorder had to be put on Warfarin. While Warfarin is effective, it isn’t a convenient drug for a patient to take. Any small change to diet, weight, or exercise level could impact the dosage. Therefore, patients need to visit their doctors regularly for blood testing, in some cases, as often as once a week.

Xarelto, however, is a one size fits all type of drug, and patients don’t have to check in as frequently. When doctors and the public learned this, it didn’t take long for the drug to become the number one prescribed blood thinner on the market. But as many patients discovered, Xarelto comes with some very serious side effects.

Possible Side Effects

Plaintiffs who have filed Xarelto lawsuits have claimed that the drug caused:

GI Bleeds

Patients have experienced vomiting or coughing up blood or noticing blood when the go to the bathroom due to internal bleeding in the GI tract. These bleeds can occur in either the upper or lower tract.

Brain Bleeds

If a bleed occurs in the veins that carry oxygen to the brain, the result is typically a stroke, which can leave the patient with delayed motor function, paralysis, slurred speech, memory loss, and loss of vision. A stroke can also be fatal.

Pulmonary Embolism

The veins that carry oxygen-rich blood to the lungs get smaller and smaller as they travel down a lung. If a clot is traveling through, it will eventually become lodged and block off the vein. This is called a pulmonary embolism.blood thinner pills

Spinal Bleeds

A fall or surgical procedure can cause a spinal bleed. This is dangerous for someone who is perfectly healthy, let alone a patient who is on blood thinners. Due to the presence of the drug, the body is unable to form a healthy clot to stop the bleeding, which can lead to pooling around the spinal cord and possible paralysis.

Unstoppable Bleeding

Arguably the most dangerous issue with Xarelto is that once bleeding starts in any part of the body, either internal or external, it is almost impossible to stop the bleeding. Older blood thinners have an antidote, Vitamin K, that can be administered if a patient is in danger of exsanguinating. Xarelto has no antidote which means that doctors have to perform a blood transfusion, a procedure that doesn’t work in time to save the patient’s life.

It is these side effects that have caused serious harm to a patient or even ended their life which led to the filing of thousands of personal injury lawsuits and wrongful death lawsuits against Bayer AG and Janssen Pharmaceuticals. Plaintiffs are hoping not only to obtain compensation for their medical expenses, lost earnings, pain and suffering, funeral expenses, and loss of enjoyment in life, but they are hoping to bring enough national attention to Xarelto that the drug is recalled by the FDA.


Thanks to our friends at Rome, Arata, Baxley LLC, 18 Wheeler Wreck Attorneys, for their contributions to this post.

Leave a Reply

Call Now Button