NAVIGATE ESUS Study Says Xarelto No More Effective Than Aspirin
The manufacturers of Xarelto (rivaroxaban), 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.
Anticoagulants or blood-thinners work by stopping the blood from clotting. This helps 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.
Some of the potentially fatal conditions Xarelto users have suffered include gastrointestinal bleeding, brain hemorrhaging, kidney bleeding, rectal bleeding, and other internal bleeding events.
NAVIGATE ESUS Study
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.
Thousands of injured people are demanding justice from Bayer and Janssen Pharmaceuticals. They feel that the company failed to provide adequate warnings about the risks of their drug. They didn’t have the chance to make an educated decision based on their health.
The Michael Brady Lynch Firm is still accepting cases in all 50 states. If you or a loved one experienced a serious bleeding event after taking Xarelto, let our decades of experience help you. We know exactly how to go up against large companies and get you the justice you deserve. Contact us today to speak with a knowledgeable attorney for a free consultation.