The FDA has announced that there will still be no approved antidote for the blood thinning medication, Xarelto, which is manufactured by Bayer. They have stated they will be unable to approve the recently developed antidote, called AndexXa, until they receive more information from the drug’s manufacturer.
What is Xarelto?
Xarelto is an anticoagulant, also known as a blood thinning medication, which was approved for use in elevated risk patients in 2011. It is used to reduce the risk of certain diseases such as strokes, deep vein thrombosis, pulmonary embolism, and, obviously, blood clots.
With no antidote currently on the market, however, it could be the most dangerous available option. Patients needing the use of blood clotting medications are strongly urged to seek alternatives to its use until an antidote is available.
The Serious Dangers Presented from Excessive Bleeding
Excessive bleeding caused by Xarelto does NOT have a cure. While blood thinning medications are viable treatment options for people suffering from disease such as atrial fibrillation (A-Fib), blood which is unable to clot poses serious risks. A person could potentially die from a papercut were there blood to be unable to clot. Therefore, antidotes were created which will reverse these effects when necessary.
Xarelto users are the unlucky ones. Without an antidote, doctors and surgeons have little to no options in treating emergency situations.
AndexXa: A Possible Antidote to Xarelto
AndexXa is the first possible antidote to the blood thinning effects of Xarelto. It is developed by Portola and was first placed for approval before the FDA in August 2016. Prior to approval, however, the FDA stated they would like more information on the company’s manufacturing practices. They also wanted more data to further include two extra anticoagulants along with Xarelto: enoxaparin, and edoxaban.
What Is Happening Without an Antidote: The Statistics
Last year alone, Xarelto was linked by the FDA to cause over 15,000 side effects. This was an increase of 41% from the previous year. Xarelto causes more emergency room trips than any other prescription medication and accounted for nearly three-quarters of all drug-related adverse effects in 2016.
Thousands of people prescribed Xarelto have been speaking out against the drug and taking a stand against what they believe is a company profiting on their pain. These people are seeking compensation for their injuries, or for the death of their loved ones. Thousands of lawsuits have already been filed, and the number continues to grow rapidly.
To further complicate matters, the drug must be appropriately administered and there is a very small window of time to do so. Taking too much or too little of the drug has dire consequences, thus leading to even more injuries or deaths as a result.
If you believe you may be among those eligible to file a lawsuit against the company due to injuries or death of a loved one, Drugwatcher offers free consultations. They can provide additional information which will help you decide what your next step should be.