Institute for Safe Medication Practices
The Institute for Safe Medication Practices (ISMP) is a nonprofit organization. It provides lists of legal drugs responsible for most injury and adverse event reports. In 2016, ISMP reported that blood thinners – or anticoagulants – were linked to 21,996 adverse events and 3,018 deaths.
Xarelto Bleeding Lawsuits
Xarelto was responsible for most adverse event reports among blood thinning drugs. Xarelto is linked with thousands of blood thinner lawsuits.
Patients who are at risk of developing blood clots are often prescribed anticoagulants or blood thinners. Each blood thinner targets a particular blood clotting factor to prevent or reduce the formation of blood clots.
Blood Clotting 101
Blood clotting isn’t always bad, of course. In most cases, blood clotting is vital for preventing small bumps or cuts from becoming severe bleeding events. Preventing this natural healing process from occurring, especially when a blood thinning drug’s concentration is too strong or improperly balanced, may cause some to suffer uncontrollable bleeding.
Blood Thinners like Xarelto linked with Most Emergency Room visits
In 2016, internal hemorrhages made up most blood thinner injuries reported to the FDA:
• 17,218 anticoagulant-related hemorrhages
• 8,495 gastrointestinal hemorrhages
• 1,019 cerebral hemorrhages
Some of these adverse events were serious enough to require an emergency room visit. The ISMP authors warned that 6.3% of patients on blood thinners will require an E.R. visit, and half those visits will require hospitalizations. Patients on blood thinners, were, in fact, 2.4 times more likely to need an E.R. visit than patients prescribed opioids, which are prominently in today’s news due to a nationwide epidemic.
Anticoagulants were responsible for 17.6% of all FDA-reported hospitalizations, more than opioids or any other type of drug.
Xarelto Lawsuits over Unacceptably High Safety Risk
Drug injury attorneys filing Xarelto blood thinning lawsuits believe that Xarelto’s maker and marketer, Bayer and Janssen (part of Johnson & Johnson) have created an unacceptably high safety risk for many patients placed on the blood thinner. Thousands of claims have now been filed in the Xarelto multidistrict litigation (MDL) set in the federal Eastern District of Louisiana.
Xarelto’s Dosage Problem
Monitoring blood thinner concentration level is important because Xarelto can create “peaks and troughs” in the drug’s severity for some patients. This creates a particular problem for Xarelto’s once-daily dosing. Bayer and J&J have used the once-daily routine to market Xarelto as a more convenient alternative to its cheaper generic competition – Warfarin – which requires a dosing twice daily.
A once-daily dosing may seem more convenient, but it may leave a patient more vulnerable to strokes or bleeding events. A once-daily schedule can create inconsistencies in the drug’s concentration. It may be too weak at times and hence present a stroke risk; or it may be too strong at other times and present an uncontrollable bleeding risk.
Xarelto also poses potentially greater health risks than Warfarin because it does not require regular patient monitoring. Regular medical visits, by contrast, could help patients receive an accurate dosage, and prevent dangerous fluctuations in the blood thinner’s concentration. According to a 2017 Mayo Clinic study, one in six patients on newer blood thinners may be prescribed the wrong dosage.
Xarelto Still Lacks an Antidote
Of the more than 17,000 patients who suffered a blood thinner-related hemorrhage in 2017, those on Xarelto (rivaroxaban) had no access to an antidote to help stop the bleeding. Without a reversal agent to stop bleeding, these events could quickly become life-threatening.
Pradaxa allegedly caused 1,000 deaths
An antidote for Pradaxa (dabigatran) was not approved until 2015; that was not soon enough to prevent more than 1,000 casualties allegedly caused by the blood thinner.
An antidote, ISMP researchers said, could significantly reduce the number of fatalities and serious injuries. Warfarin has had a simple vitamin K antidote available for years, but despite this major difference, Xarelto and Pradaxa were marketed as superior alternatives.
Xarelto, Pradaxa Lawsuits Nationwide
This dangerous risk of bleeding, combined with misleading advertising, inadequate warnings and a lack of antidote, has resulted in thousands of lawsuits against Xarelto and Pradaxa makers.
New Orleands MDL: 14,000 Xarelto Lawsuits
Some 14,000 Xarelto lawsuits are consolidated in New Orleans. Thousands more have been filed in state courts against Bayer and Janssen, the Johnson & Johnson subsidiary that markets Xarelto in the U.S.
Pradaxa Lawsuit Settlement
In 2014, Boehringer Ingelheim (Pradaxa’s manufacturer) settled 4,000 of its lawsuits for $650 million. This was before an antidote was available, however, so some patients were still suffering from Pradaxa-related injuries. Therefore, Pradaxa litigation is likely far from finished for Boehringer Ingelheim.
Blood Thinner Injury Lawsuit Help
Our experienced drug injury attorneys are handling lawsuits against the makers of Xarelto and other blood thinner drugs. If you or someone you love was injured by Xarelto, email us for a free legal consultation or call 888-520-520. You may be entitled to significant compensation.
Time limits apply to filing lawsuits, so we urge anyone with a potential case to call us immediately for a free, no obligation consultation.