Xarelto Side Effects & Health Complications
Xarelto® (rivaroxaban) helps prevent stroke and blood clots in pulmonary embolism and deep vein thrombosis patients. Unlike warfarin, Xarelto blood thinner patients don’t need monthly blood monitoring. However, many Xarelto patients risk uncontrolled internal bleeding episodes. Unfortunately, some Xarelto patients require hospitalization and even bleed out. Now, injured patients are suing the manufacturer for failing to warn consumers about serious Xarelto side effects. In addition, plaintiffs say the drug’s manufacturers didn’t properly warn doctors that no Xarelto antidote exists to reverse uncontrolled or internal bleeding. In December 2017, a jury awarded the first Xarelto settlement totaling $27.8 million to an Indiana couple.
How Xarelto Side Effects Compare to Other New Wave Blood Thinners
The Food and Drug Administration approved rivaroxaban (Xarelto) in 2011 to reduce stroke risk in atrial fibrillation patients. Xarelto’s closest rival is another newer anticoagulant, Pradaxa® (dabigatran), which also has severe bleeding episode risks. A 2012 report from the Institute for Safe Medication Practices found that Xarelto’s adverse events surpassed those reported with Pradaxa. The report attributes the rise in adverse events to doctors writing more Xarelto prescriptions.
“Total dispensed outpatient prescriptions for rivaroxaban have rapidly increased to nearly one million prescriptions per quarter, while dabigatran utilization has steadily declined since a peak in early 2012,” said IMSP. In fact, doctors prescribed Xarelto blood thinner almost twice as often as Pradaxa in 2013. Both anticoagulants are supposedly easier to use and require less blood monitoring than Coumadin, making them warfarin’s most likely successors. And while Vitamin K is an effective Coumadin antidote to stop uncontrolled internal bleeding, no Xarelto reversal agent currently exists. This means any internal bleeding episode or minor injury could be fatal. As a result, many wrongful death lawsuits are now pending against manufacturer Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals.
Xarelto Side Effects During Pregnancy
A Canadian study published in the American Journal of Obstetrics and Gynecology observed rivaroxaban (Xarelto) use among pregnant women. According to Everyday Health, pregnancy makes women six times more likely to develop deep vein thrombosis. Often, physicians prescribe blood-thinning medication to women fighting this health issue. However, researchers now say that Xarelto may not be the best anticoagulant for pregnant women.
The study reported that rivaroxaban rapidly crossed the placental barrier in both maternal-to-fetal and fetal-to-maternal directions over three hours. In other words, taking Xarelto while pregnant may potentially harm your baby. But the study also notes that since rivaroxaban is highly bound to plasma proteins, it could significantly reduce the unbound drug amount reaching the fetus. In conclusion, researchers recommend additional studies on Xarelto use during pregnancy to understand all risks.
The drug’s warning label says Janssen didn’t conduct any Xarelto safety studies on pregnant women. Still, it does say patients can use the drug if potential benefits outweigh any risks. Therefore, pregnant women unwilling to risk serious Xarelto side effects (like uncontrolled bleeding) can choose a different anticoagulant medication.
Lawsuit Cites Insufficient Warnings About Xarelto Side Effects
In July 2014, 71-year-old Jeanne Jeffcoat sued Janssen for failing to adequately warn consumers about dangerous Xarelto side effects. Jeffcoat took Xarelto for only four months before she was hospitalized with uncontrollable hemorrhaging in July 2012. Her lawyers say complications from Jeffcoat’s bleeding episode caused permanent injuries, pain, suffering, and a need for ongoing medical care.
Jeffcoat’s claim says that Janssen markets Xarelto as a superior anticoagulant despite the fact that no antidote currently exists. Warfarin, a different blood thinner medication, can be countered with vitamin K to keep patients from bleeding out. Jeffcoat’s lawyers say that Xarelto’s label did not have sufficient warnings regarding the lack of available reversal agent. Her lawsuit also cites a 2013 FDA warning letter about advertising “false or misleading” Xarelto side effects and efficacy claims.
In 2015, the FDA received 10,674 adverse event reports due to Xarelto side effects, including 1,121 deaths. According to ISMP’s QuarterWatch, Xarelto is linked to more fatal, disabling or serious injuries in the U.S. than any other drug. Unfortunately, many rivaroxaban patients die during severe or internal bleeding episodes.
If you or a loved one took Xarelto and required hospitalization for internal bleeding, you may qualify for compensation. Victims’ family members may also wish to file a wrongful death lawsuit due to fatal Xarelto side effects.
Check eligibility for compensation.
If you or a loved one experienced blood clots, uncontrolled bleeding or death while taking Xarelto, you may qualify for financial compensation from the manufacturer. Request your free case evaluation now to see if you may qualify.