Published on:

FDA Rejects Approval of Xarelto Antidote

The makes of Xarelto (Bayer and Johnson & Johnson) took a major hit this week in terms of the future of there flagship drug.  Xarelto is a member of a relatively new class of drugs called New Oral Anticoagulants (NOACs).  NOACs are used for patients who suffer from a series of medical conditions including deep vein thrombosis (DVT) and atrial fibrillation (Afib).  Afib is a serious medical condition that causes an irregular heartbeat when the patient does not have a heart valve defect.

whitepillsIn addition to Xarelto, Pradaxa, Eliquis and Savaysa are members of this new class of NOACs.  Traditionally, before these medications were on the market, patients would take Warfarin (Coumadin) as a blood thinner.  Warfarin is known to work and is relatively safe as long as patients do what they are told to do by their doctors.  However, since patients do not always do what they are told, the drug is not always so convenient to take and may result in a serious internal bleeding disorder.  However, if a patient does suffer from internal bleeding, a doctor can prescribe a reversal agent (antidote) to allow the patient to clot normally so the bleeding will stop. What a patient must do to prevent this is make sure he or she watches his or her diet and avoids green leafy vegetables such as kale.  The reason for this is because these vegetables can cause a chemical imbalance and that can lead to bleeding.  They must also undergo routine blood testing to make sure the absorption rate is okay for the given dose.

Xarelto, on the other hand, is not supposed to need constant monitoring, as there is only one dose.  This is supposed to be a lot more convenient and lot safer than Coumadin.  The truth, as our Boston Xarelto injury lawyers have seen, is that patients on Xarelto may develop a serious internal bleeding disorder, including intracranial bleeding, and there is nothing doctors can do to stop the bleeding, as there is no antidote.  Pradaxa, which has also been shown to cause them same internal bleeding now has an approved antidote called Praxbind.  The makers of Xarelto were hoping to get a drug known as AndexXa on the market as an antidote to Xarelto.  This drug, made by a company called Portola was supposed to stop Eliquis patients form bleeding as well.

Unfortunately, according to a recent news feature from Drug Watch, the FDA has rejected this new Xarelto reversal agent, so the drug remains potentially deadly, as there is, once again, no way to stop the bleeding in patients who present with a Xarelto bleeding disorder.

The hope is that with these new antidotes for NOACs, sales would stay strong, as Xarelto alone has already turned revenue totals of over a billion dollars since it was first on the market in 2014.  It should be noted that the FDA left the door open for the company to refile the application with certain additional testing documents to show that not only is it effective, but also that it is safe.

Call the Boston Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

Additional Resources:

FDA Rejects Xarelto Uncontrolled Bleeding Antidote, August 28, 2016, Drug Watch

More Blog Entries:
FDA Announces Testosterone Meds Must Carry Broader Warning, July 7, 2014, Boston Products Liability Lawyers Blog