XARELTO® (or rivaroxaban) and Pradaxa® (or dabigatran) are both prescription medications classified as a one of the newest anticoagulants, more commonly known as blood thinners. XARELTO® is developed by Johnson & Johnson’s New Jersey-based Janssen Pharmaceuticals and Bayer Health Care, while Pradaxa® is manufactured by a competing company called Boehringer-Ingelheim. Both medications are used to reduce the risk of stroke and of dangerous blood clots that can obstruct the flow of blood to the vital organs. They are prescribed in a variety of situations:
- To reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem.
- To treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.
- To reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.
Boehringer-Ingelheim, Johnson & Johnson and Bayer promoted Pradaxa® and XARELTO® as a superior alternative to warfarin (Coumadin, Jantoven), which had been the go-to anticoagulation therapy for the past 60 years. Both Pradaxa® and XARELTO® were more appealing to the anticoagulant therapy market because these drugs were said to have fewer contraindications and require less frequent monitoring than warfarin. The older anticoagulants require doctors to prescribe specific doses for each individual, and doses may change over time based on the patient’s blood chemistry, overall health and other factors. The patient must make many visits to the doctor daily at the outset of treatment, and frequently thereafter. Warfarin also interacts negatively with several other medications and foods (primarily green, leafy vegetables), making it a complex drug to manage. Pradaxa® and XARELTO® belong to a new type of oral anticoagulant that purports to offer advantages in that it is prescribed in one uniform, once-a-day dose and has fewer negative interactions, making it easier to cope with and less time consuming for both doctors and patients.
When the drug causes harm
Naturally, with a drug of this sort, there are expected risks and complications. For example, patients taking anticoagulants, or blood thinners, are likely to bruise more easily and take longer to stop bleeding from a cut. This is because the medication interferes with the blood’s normal ability to form clots. As a consequence, anyone on anticoagulation drug therapy must take extra precautions in daily life and must carefully consider surgical procedures in consultation with their doctor.
In most cases, the normal consequences of blood thinners are easily managed; however, in some cases, more serious side effects occur. One of the most severe side effects is uncontrolled bleeding. When bleeding occurs near a major organ, such as the brain, lungs, or kidneys, blood flow to that organ is interrupted, causing it to lose some or all of its functionality. This is known as a full or partial shut-down. If a vital organ shuts down due to lost blood supply, death is almost certain to follow. Another potential consequence of uncontrolled bleeding is that pools of blood may form within the body. The pressure from these pools of blood can exert stress on nearby organs, nerves, and blood vessels, causing pain and possible system failure. Clots can also break free from these pools of excess blood, travel to the heart or brain, and precipitate a heart attack or stroke.
With older anticoagulant medications, internal bleeding complications can be managed by administering a reversal agent or antidote drug which restores the blood’s ability to clot. For warfarin, many reversal agents are available, including prothrombin complex concentrates (PCCs), recombinant activated factor VII (rFVIIa), plasma, and vitamin K. However, there is no known reversal agent for Pradaxa® or XARELTO®, so hemorrhaging will continue until the drug is flushed out of the system. This is especially dangerous for older people because their metabolism is slower and the drug lingers longer in their systems. By the time the drug is cleared from their bodies, these patients may have suffered irreversible damage or even death.
Two of a kind
Pradaxa® is similar to XARELTO®, but it has a slightly different mechanism for thinning the blood. XARELTO® inhibits a protein involved in the coagulation process called Factor Xa, which interrupts the blood-clotting process and prevents another protein, thrombin, from forming. Pradaxa® works directly on the thrombin to inhibit its formation. Interestingly, the newer anticoagulants are more costly than the old standard medication, warfarin—Pradaxa® and XARELTO® both cost about $3,000 a year compared with $200 for warfarin. However, because these drugs do not require frequent doctor checkups, offer a uniform, “one-size-fits-all” dose, and involve fewer negative interactions with other drugs and foods, they are very popular among doctors and patients despite the cost.
Unfortunately, both XARELTO® and Pradaxa® are known to cause serious side effects, including death, and have come under investigation by the FDA, but XARELTO® seems to be the worst of the two. In 2014, a report showed that the number of complaints involving XARELTO® has surpassed Pradaxa®, which had at one time generated more severe or fatal health problems than any other drug monitored by the reporting group. Patients using XARELTO® experienced 20 percent more serious adverse events than those using Pradaxa®. Since the two drugs were introduced, the FDA has received almost 50 percent more complaints about serious injuries related to XARELTO® than Pradaxa®. In total, since XARELTO® was introduced to the market, a stunning 21,000 adverse event reports have been submitted.
Although XARELTO® and Pradaxa® are still on the market, federal judges have ruled that those injured by these medications can file lawsuits against the manufacturers for their losses.
If you or a family member have experienced a serious bleeding complication after taking XARELTO® or Pradaxa®, call us now toll-free at (800) 210-4539 or fill our online form for a free consultation. Our experienced team of personal injury attorneys will listen to your story, assess your chances for a successful claim, advise you on how to move forward, and help you do the legwork. We can help you obtain a just settlement for your pain and suffering.