FDA announced that Bayer’s popular blood thinner, Xarelto, will still not have an approved antidote. The government agency will not approve the antidote, AndexXa, without additional information from the manufacturer, Portola. This pushes back the possible approval date to May 2018.
About Xarelto
Approved by the FDA in 2011, Xarelto is used to reduce the risk of deep vein thrombosis (DVT), pulmonary embolism (PE), and blood clots. Manufacturers Bayer and Janssen promote the drug has the gold standard for anticoagulants. However, it may be more dangerous than other medications on the market since there is no antidote.
No Way to Stop Xarelto’s Bleeding
By stopping the blood from clotting, blood-thinners can prevent blood clots in people suffering from conditions such as atrial fibrillation. Due to the risk of unstoppable bleeding, researchers developed an “antidote” to stop this effect in the case of emergency in users of warfarin, the most popular anticoagulant for decades.
Xarelto users aren’t so lucky. There is no antidote to reverse the anti-clotting effect of Xarelto in an emergency. This means doctors and surgeons may have limited options. It means that what could be a treatable injury for most people can be a fatal one for Xarelto users. Additionally, unlike other anticoagulants, Xarelto doesn’t push regular blood monitoring. With regular blood monitoring, doctors can adjust the dosage to ensure patients aren’t at risk.
AndexXa
Portola, the developer of AndexXa first asked the FDA for approval in August of 2016. The FDA wanted to know more information about Portola’s manufacturing practices along with additional data for inclusion of two other anticoagulants in the label, edoxaban, and enoxaparin.
Pfizer and Bristol-Myers, the makers of Eliquis another blood thinner wanted AndexXa on the market so desperately they provided Portola with $25 million in unsecured loans to help cover the costs of additional development and clinical studies of AndexXa. Plus, there are marketing agreements in place post-approval.
Dangers of No Antidote
Without an antidote, blood thinners like Eliquis and Xarelto harm thousands. Last year, the FDA linked Xarelto to over 15,000 adverse events from using the anticoagulant. This is a 41% increase from 2015. Plus, the drug caused more emergency room visits than any other medication. In fact, Xarelto accounted for almost 70% of all adverse events in 2016. Internal bleeding caused nearly all of the injuries. Internal bleeding that could have been avoided if Bayer insisted Xarelto had an antidote before it went to market.
Xarelto Lawsuit
Thousands of patients are speaking out against Xarelto. They decided to take a stand and ask for compensation from the manufacturers Bayer and Janssen. They feel these companies are profiting from their pains and their loved ones’ deaths. The drug is dangerous because the administration can be difficult, and it can complicate the healing of wounds. There is a tiny window of time between a safe Xarelto dose and a dangerous one. Overdose or not enough of the medication is a grim reality.
Xarelto lawsuits are similar to lawsuits over Pradaxa, another newer-generation anticoagulant. Michael Brady Lynch, the founder of The Michael Brady Lynch Firm is leading the country in Pradaxa lawsuits. Michael was a member of the Plaintiff’s Steering Committee in the Pradaxa Multi-District Litigation and was instrumental in securing the $650 million settlement for those injured by Pradaxa’s uncontrollable bleeding. Mr. Lynch continues to be a leader in Pradaxa litigation nationwide in representing those who continue to suffer uncontrollable bleeding events from Pradaxa.
Attorney Lynch has said, “The U.S. numbers for Pradaxa bleeding events are truly staggering. It is on the verge of a national health disaster.”