Recently, Bayer and Johnson & Johnson announced new clinical trials for their anticoagulant drug Xarelto (rivaroxaban). The studies, NAVIGATE ESUS, VOYAGER PAD and GEMINI 1 and 2 ACS, address three potential additional indications for Xarelto:
- Acute Coronary Syndrome (ACS),
- Strokes caused by clots of unknown origin, and
- Peripheral artery disease (PAD).
Xarelto is currently prescribed in the U.S. to prevent and treat deep vein thrombosis and pulmonary embolism and prevent strokes in people with non-valvular atrial fibrillation.
Xarelto is a Factor Xa inhibitor. It is considered to be in a “new generation” of anticoagulants which also includes Pradaxa (Boehringer Ingelheim GmbH) and Eliquis (Pfizer Inc. and Bristol-Myers Squibb Co.). These medications are meant to contrast vitamin K antagonists such as warfarin. One difference is that the newer anticoagulants do not require continual monitoring via blood testing, which warfarin does. An important difference, however, is that while the negative effects warfarin can be reversed the effects of Xarelto cannot.
Additional indications would mean an increase in prescriptions written for Xarelto, which would mean an increased profit for Johnson & Johnson, the manufacturer of Xarelto. However, it would also mean an increased risk of bleeding to numerous people who receive those prescriptions. The side effects of Xarelto include severe internal bleeding, including gastrointestinal bleeds and intracranial hemorrhages. There is currently no reversal agent for bleeding caused by Xarelto. As a result, these bleeds can cause hospitalization and sometimes even death.
Development of a potential antidote for Factor Xa inhibitors
A California-based company, Portola Pharmaceuticals, is developing a potential antidote for Factor Xa inhibitors, which would include Xarelto and Eliquis. The potential antidote is called andexanet alfa, and is currently being testing in a Phase 3 study called ANNEXA. The results of the ANNEXA-A study, which involved the drug Eliquis, will be presented in November at the American Heart Association Scientific Sessions. The company announced recently that ANNEXA-A showed positive results for efficacy and safety when tested on the effects of Eliquis, meaning it reversed the effects of Eliquis without serious adverse events being reported. Portola has also tested andexanet alfa on the effects of Xarelto in Phase 1 and 2 studies. If an antidote such as andexanet alfa were to be approved by the FDA and made available for use, then it could be used to treat those who develop serious bleeds while using Xarelto.
Ashcraft & Gerel, LLP is investigating possible lawsuits against the makers of Xarelto. Our experienced dangerous pharmaceutical and medical device attorneys have successfully handled many similar cases in the past. If you or someone you know has experienced any of the symptoms listed above as a result of taking Xarelto, you may be entitled to compensation. Please contact us online or call us at (800) 674-9725 to speak with an attorney today. All consultations are free and completely confidential.