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 those who use this medication. Additionally, unlike other anticoagulants, this blood thinner doesn’t push regular blood monitoring. With regular blood monitoring, doctors can adjust the dosage to ensure patients aren’t at risk.
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.
Without an antidote, blood thinners like 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.
Many Xarelto Deaths
Despite its short time on the market, Xarelto may already be responsible for hundreds of patient deaths. The FDA has linked the anticoagulant to:
- 22,000 serious complications in 2016
- 3,018 deaths reported to the FDA
- Responsible for 68.4% of all adverse events in 2016
Media reports also indicate that Xarelto may also be involved in 130 deaths in Germany.
ISMP 2015 Study on Rivaroxaban
Institute For Safe Medication Practices (ISMP) examined all the adverse events submitted to the FDA after patients took Xarelto. They also examined all the adverse events reported to the FDA after patients took the coagulant. Then, they determined that the blood thinner failed to prevent pulmonary embolism, caused uncontrollable bleeding, and wasn’t very efficient.
They also determined that:
- There were 1,121 patient deaths
- 10,674 reported fatal, disabling or serious injuries
- 9% involved bleeding cases
- 9% embolic thrombotic or blood clot events
Xarelto As Effective As Aspirin
In October 2017, Bayer and Janssen stopped phase III of the NAVIGATE ESUS study early, when researchers showed the drug did not prevent stroke or increased bleeding better than over the counter aspirin. This screams an attempt by the manufacturers trying to get FDA approval for another use of the medication. Bayer and Janssen are trying to regain control of the anticoagulant market. They don’t care if more people have uncontrollable bleeding events from their medication in the process.
Xarelto Loses Lead and Consumers Suffer
Xarelto was a huge financial success. It made $642 million in the US in the second quarter of this year alone, but it used to dominate the anticoagulant market. Now, another equally dangerous anticoagulant, Eliquis has edged out the medication from being in the top spot.
This pushed Bayer and Janssen to try to get more people to try the dangerous medication. In 2011, the FDA approved the medication to help deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery. Since then, the FDA approved Xarelto for several other reasons such as the general treatment of DVT in adults.
Now, the manufacturers set their eyes on stroke victims. The NAVIGATE ESUS trial included 7,214 patients from 31 countries. Researchers randomly gave patients once daily either 15 mg of rivaroxaban or 100 mg of aspirin. There was not a difference in stroke prevention from those taking either Xarelto or aspirin.This study was a failed attempt to push the hazardous drug on a new group of people. It is unclear if the manufactures will continue the study at a later date. An Eliquis study of the same nature is set to complete in December 2018.
Dangerous Drug Interactions
According to a paper published in the Journal of American Medical Association (JAMA), researchers from Taiwan analyzed data on 91,000 patients who were using anticoagulants, including Xarelto, Eliquis, and Pradaxa, either alone or with other medications. Their findings indicated that patients who took the anti-fungal medication Diflucan in combination with Xarelto were 25% more likely to suffer a major bleeding event.
Xarelto is a dangerous medication that continues to become even more dangerous as we learn different medication combinations. When will the FDA take a stand a recall this harmful drug?
As of October 2017, the FDA has not recalled Xarelto despite its potential to cause harm. In 2011, some FDA scientists did not even want to approve the drug in the first place. They felt patients were at a greater risk of stroke or bleeding when using the blood thinner than the trusted warfarin. In one clinical trial, 30 days after the study ended Xarelto subjects had experienced 22 strokes while warfarin users had experienced just six.
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 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.”
Speak to an Attorney Today
If you or a loved one has been harmed by Xarelto, you need an attorney with experience helping people who have been harmed by pharmaceutical drugs. The attorneys at the Michael Brady Lynch Firm know what it takes to go up against drug manufacturers to get clients what they need.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If the conduct of a drug company in manufacturing and selling drug is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you had a bleeding event after taking Xarelto, please speak to us to learn more about your rights.
Case evaluations are free of cost and without obligation. Call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.