Drug injuries have increased twofold in the last decade, according to the Food and Drug Administration’s adverse event database. Out of the more than one million adverse events reported to the FDA just last year, patients complained of their blood thinners the most.
The Institute for Safe Medication Practices (ISMP), a nonprofit organization, provided a breakdown of the pharmaceutical drugs that received the most injury and adverse event reports in their recently released 2016 annual report. Blood thinners, or anticoagulants, were connected to 21,996 adverse events and 3,018 deaths.
This group of pharmaceutical drugs includes Xarelto, Pradaxa, Eliquis, Warfarin, Coumadin, and Savaysa. Xarelto, a drug which is linked to thousands of lawsuits, was responsible for the bulk of adverse event reports.
Blood Thinner Risks Are “Unacceptably High”
Patients who are at risk of developing blood clots—which can potentially stop blood flow to vital organs—are often prescribed anticoagulants. Each blood thinner targets a particular blood clotting factor to prevent or reduce the formation of blood clots.
Blood clotting isn’t always bad though; in fact, in most cases, it’s vital in preventing small bumps and cuts from turning into severe bleeding events. By preventing this natural healing process from occurring, especially when the drug’s concentration is too strong, some patients may suffer from uncontrollable bleeding.
In 2016, internal hemorrhages made up the bulk of blood thinner injuries reported to the FDA:
- 17,218 reported anticoagulant-related hemorrhages
- 8,495 reported gastrointestinal hemorrhages
- 1,019 reported cerebral hemorrhages
Some of these events were serious enough to require an emergency room visit. Overall, the ISMP authors warn, 6.3% of patients on blood thinners will require an E.R. visit, and half of those visits will require hospitalizations.
These numbers surpass any other type of drug. Altogether, anticoagulants were responsible for 17.6% of all FDA-reported hospitalizations.
“The manufacturer has created an unacceptably high safety risk for many patient’s prescribed this drug.”
It’s a statistic that should raise alarms in the medical community. Patients on blood thinners were 2.4 times more likely to require an E.R. visit than patients who were prescribed opioids—a drug type currently responsible for the nation’s worst drug epidemic.
ClassAction.com attorney Michael Goetz is part of the Plaintiffs’ Steering Committee for the Xarelto multidistrict litigation (MDL), filed in the federal Eastern District of Louisiana. The MDL includes thousands of claims alleging injuries caused by Xarelto.
“These new results are not surprising and confirm what we’ve said from the beginning: that certain members of the patient population are at heightened risk for major bleeding events while on Xarelto,” he told us. “In the absence of stronger warnings or a way to monitor a patient’s Xarelto concentration level or an antidote, the manufacturer has created an unacceptably high safety risk for many patient’s prescribed this drug.”
Xarelto’s Once-Daily Dosage Problem
Monitoring blood thinner concentration level is important in that the medication can create “peaks and troughs” in the drug’s severity for some patients.
It’s a particular problem for Xarelto’s once-daily dosing, which has been marketed as a more convenient alternative to the generic warfarin, which requires twice-daily dosing.
But while a once-daily dosing may seem easier for the patient, it may leave them more vulnerable to strokes or bleeding events. Taking anticoagulants only once a day can create inconsistencies in the drug’s concentration—too weak at times (presenting a stroke risk) and too strong at others (making patients vulnerable to bleeding).
Xarelto also poses potentially greater health risks than Warfarin in that it does not require regular patient monitoring. Regular medical visits could help ensure patients receive an accurate dosage, one that prevents 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 17,000-plus patients who suffered a blood thinner-related hemorrhage last year, those who were on Xarelto (rivaroxaban) did not have access to an antidote to help stop the bleeding. Without a reversal agent to stop blood flow, these events could quickly become life-threatening.
Pradaxa allegedly caused 1,000 deaths.
An antidote for Pradaxa (dabigatran) was only recently approved in 2015. Unfortunately, this was not soon enough to prevent the more than 1,000 casualties allegedly caused by the blood thinner.
An antidote, ISMP researchers stated, could reduce the amount of fatalities and serious injuries in patients significantly. Warfarin has had a simple vitamin K antidote available for years, but despite this major difference, Xarelto and Pradaxa were marketed as superior alternatives.
Thousands File Lawsuits Against Xarelto, Pradaxa
This dangerous risk of bleeding, combined with misleading advertising and an absence of warnings and antidotes, has resulted in thousands of lawsuits against Xarelto and Pradaxa manufacturers.
There are currently 14,000 Xarelto lawsuits consolidated in New Orleans. Thousands more have been filed in state courts against manufacturer Bayer and Janssen, the Johnson & Johnson subsidiary who markets the drug in the U.S.
In 2014, Boehringer Ingelheim (Pradaxa’s manufacturer) settled 4,000 of its lawsuits for $650 million. This was before an antidote was available, though, so some patients were still suffering from Pradaxa-related injuries. Because of this, litigation is likely far from over for Boehringer Ingelheim.
Blood Thinner Injury? We Can Help
ClassAction.com attorneys are filing lawsuits against Xarelto and Pradaxa manufacturers. If you or a loved one suffered uncontrollable bleeding while taking either blood thinner, contact us today for a no-obligation case evaluation. It costs nothing unless we win a jury award or settlement for you.