Xarelto: Drug Can Cause Dangerous Bleeding, Injury or DeathDecember 1, 2014 | Category: Prescription Errors | Share
In 2011, Xarelto (generic name - rivaroxoaban) was introduced into the United States market by Johnson & Johnson's Janssen Pharmaceuticals subsidiary, and their Bayer Healthcare AG division. The manufacturer heralded it as a blood anti-coagulant and as a replacement for the blood thinners, Warfarin and Coumadin, which had been the standard prescription for over 50 years. Even though Coumadin (generic name - warfarin) can cause bleeding, there are FDA-approved ways of stopping this bleeding in emergency situations. In addition, patients on these medications have been required to take monthly blood tests to monitor the side-effects in relationship to the drugs' dosages.
Since Xarelto's introduction to the market, physicians have been writing prescriptions for this drug to reduce the risk of pulmonary embolism (PE), stroke, deep vein thrombosis (DVT), and other blood clot injuries. It is now also the drug being used by many surgeons following knee and hip replacement surgery and is a way of preventing the re-occurrence of blood clots. On the manufacturer's website for Xarelto (www.xarelto-us.com), it says that more than 9 million people worldwide have been prescribed Xarelto to date. This information is also confirmed by www.drugs.com, which is widely-used by physicians' as an information source.
Although all blood thinners have the risk of internal bleeding, it appears that the manufacturer of Xarelto has failed to adequately advise physicians that Xarelto can cause excessive bleeding problems, and that there is no approved FDA reversal agent. Data collected by the FDA (Food and Drug Administration) since Xarelto's introduction points to a much greater risk than the manufacturer indicated in the warnings provided to the medical community and consumers.
Through September 2014, over 3,000 cases of adverse side-effects have been reported to the FDA from patients using Xarelto or the prescribing physicians. These reports have covered the increased risks of bleeding, potential and actual deaths associated with taking Xarelto, and the failure of Johnson & Johnson and Bayer Healthcare AG to adequately warn of these risks.
Specific side-effects, including reports of wrongful death from bleeding problems, which have been reported to the FDA have included:
- Extensive internal bleeding
- Brain hemorrhaging
- Severe and frequent nose bleeds
- Gastrointestinal bleeding
- Pulmonary embolisms
- Kidney bleeding
As the result of the drug maker's failure to adequately warn about the risks associated with the anti-coagulant, Xarelto, financial compensation may be available through a lawsuit. If stronger warnings had been provided by Johnson & Johnson and Bayer Healthcare AG about the bleeding risks and the fact that there is currently no Xarelto reversal agent available to doctors to quickly stop hemorrhages, many patients and physicians may have elected not to use this newer medication instead of Warfarin and Coumadin. When a physician is unable to stop bleeding, the side-effects of Xarelto can increase in severity.
Rather than delaying the marketing of Xarelto until a suitable reversal agent was found, or issuing a Xarelto recall despite the large number of severe injuries and deaths reported to the FDA, the drug makers to date have decided to continue to aggressively market the drug with the confusing and misleading information. At the barest minimum a Xarelto FDA-acceptable "black box" warning should have been placed on the label to make sure the risks associated with the medication are understood. Xarelto has reached block-buster status generating in the last twelve months over $2 million in sales for the manufacturers.
"If you or anyone you know has suffered from internal bleeding, brain hemorrhaging or died while taking Xarelto, you, or they, may be entitled to financial compensation. Time for claims may be limited, so call Spivey Law, Personal Injury Attorneys, P.A. today for a free consultation," says Fort Myers Defective Drug Attorney, Randall Spivey.
Fort Myers Defective Drug Attorney, Randall L. Spivey is a Board Certified Trial Attorney – the highest recognition for competence bestowed by the Florida Bar and a distinction earned by just one (1%) percent of Florida attorneys. He has handled over 2,000 personal injury and wrongful death cases throughout Florida. For a free and confidential consultation to discuss your legal rights, contact the Spivey Law Firm, Personal Injury Attorneys, P.A., in Lee County at 239.337.7483 or toll free at 1.888.477.4839,or by email to Randall@SpiveyLaw.com. Visit SpiveyLaw.com for more information. You can contact Spivey Law Firm, Personal Injury Attorneys, P.A.in Charlotte County at 941.764.7748 and in Collier County 239.793.7748.