Excessive bleeding is the common but life-threatening side effect of the Xarelto drug. Such bleeding can cause various problems including bruising and excessive blood loss might result in death also. Taking Xarelto in combination with other drugs might result in worst cases of bleeding. One of the reasons why this is such a risk is because there is no antidote at present at the moment for these drugs. Sometimes taking Xarelto can also result in blood clots and especially patients who have undergone spinal cord tapping are at high risk when consuming Xarelto. There have been Xarelto lawsuits that have been heard of. In case any catheter patient has to be administered Xarelto, the catheter must be removed says https://www.ucdmc.ucdavis.edu/anticoag/pdf/AnticoagulationNeuraxialAnesthesia.pdf the guide for using antithrombotic agents.
There are many cases pending against Xarelto with the manufacturers Johnson & Johnson and Bayer. A division of Johnson & Johnson called as Janssen Pharmaceuticals submitted an application for approving the drug during the year 2011. The FDA has approved the drug to prevent deep vein thrombosis. It is also approved to be used to prevent pulmonary embolism after a knee or hip surgery. The ROCKET trials raised serious concerns on using Xarelto and the kind of effect it can have on the liver. FDA was not able to characterize this based on the information that was provided during the trial. There were also some issues related to the authenticity of the data that was gathered.
Lots of studies were also conducted in many areas to check for patient safety and any other potential breaches. The adverse effects of the drug have been underreported in many cases. Even though there were so many problems and FDA has been conducting many inquiries and suggesting action points, the results or the effect of the regulations were not published in any journals so far. These issues make people think how true the clinical trial results are and if the violations are not required. One of the most common trails for Xarelto is the use of Xarelto for orthopedic surgery. This had serious accusations such as discarded medical records and false reports. Due to this, FDA was not able to come to a conclusion as the proofs were unreliable.
During the year 2014, FDA informed the makers of Xarelto to add warnings and precautions before using the drug. This has to be black box warning which is the strongest type of warning that the FDA issues. The additional information that is added to the drug must include potential side effects of using the drug. Some of the side effects that has to be mentioned are using Xarelto in cases of neuraxial procedures, risks of using Xarelto for spinal puncture and epidural anesthesia, the effect of the drug on renal functions and lack of antidote in case the drug results in excessive bleeding. Another additional warning that appears is that discontinuation can lead to side effects as well.
Although FDA has been taking lots of measures to make sure that the drug is used safely, it is the responsibility of both the patient and the doctor to ensure that their body conditions allow for the drug to be used.