Xarelto, Pradaxa, and Eliquis: Blood Thinners & the Risk of Internal Bleeding
UPDATED: October 28, 2014
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Anticoagulants (sometimes referred to as blood thinners) prevent strokes caused by blood clots. They are also used to treat conditions like deep vein thrombosis and pulmonary embolisms. While anticoagulants are an important part of patient care for those who need them, they are also potentially deadly. In recent years, concerns have surfaced about the three newest drugs in the anticoagulant family: Xarelto, Pradaxa, and Eliquis. Some of those concerns have motivated injured patients to consult with personal injury lawyers who help them obtain compensation for their losses.
For many years, Warfarin was the medication that doctors most commonly prescribed for patients who needed an anticoagulant. But Warfarin is a difficult drug to administer. Finding the right dose for each patient is tricky. Giving the wrong dose can lead to health problems, including internal bleeding. Patients must submit frequent blood samples and the use of Warfarin must be rigorously monitored.
Drug manufacturers have worked to develop medications that are as effective as Warfarin but less difficult to administer. They have concentrated on creating single dose, “one size fits all” anticoagulants that do not require constant monitoring of the patient.
Pradaxa: The Leader in Lawsuits
The first replacement drug to hit the market was Pradaxa (dabigatran). Developed by Boehringer Ingelheim and approved by the Food and Drug Administration in 2010 for the prevention of strokes in patients with irregular heartbeats, Pradaxa initially appeared to be a successful drug, producing billions of dollars in revenues for the German drug manufacturer.
It soon became apparent that patients who take Pradaxa, like those who take Warfarin, experience a significant risk of internal bleeding. When patients bleed after taking Warfarin, however, doctors can give them an antidote that reverses Warfarin’s anticoagulant effects. There is no effective antidote to Pradaxa. As a consequence, thousands of patients have been hospitalized for uncontrolled bleeding after taking Pradaxa. Hundreds of those have died.
Injured patients, as well as the surviving family members of patients who died after taking Pradaxa, turned to personal injury lawyers to help them make claims for compensation. Thousands of lawsuits have been filed against Boehringer Ingelheim. Those lawsuits are generally based on evidence that the drug company failed to give patients adequate warnings about the risk of taking Pradaxa, including information about the lack of an effective antidote. Those claims have been bolstered by evidence that Boehringer Ingelheim concealed information about patient deaths from the FDA.
Boehringer Ingelheim agreed this year to settle many of those lawsuits. Since patients who did not receive adequate warnings continue to use the drug and to suffer from internal bleeding, additional lawsuits will likely be filed as the injured patients become aware of their opportunity to seek compensation.
Xarelto: The Replacement for Pradaxa
The German drug manufacturer Bayer developed the anticoagulant Xarelto (rivaroxaban) and licensed its distribution in the United States to Janssen Pharmaceuticals, a part of Johnson & Johnson. It won the FDA’s approval in 2011 to market Xarelto as a drug that could be used to prevent clotting in patients who had undergone knee surgery or hip replacements. It later persuaded the FDA to grant fast-track approval of Xarelto as a medication for treatment of deep vein thrombosis and pulmonary embolisms.
Sales of Pradaxa began to decline as lawsuits highlighting its adverse effects came to the public’s attention. At the same time, sales of Xarelto began to soar. Yet Xarelto creates the same concerns as Pradaxa. Patients who take it may experience uncontrollable internal bleeding. Janssen Pharmaceuticals acknowledges that no antidote to Xarelto’s anticoagulant effect has been developed and that dialysis will not remove the drug form a patient’s system.
According to the Institute for Safe Medication Practices, Pradaxa was the drug most frequently identified as causing adverse patient reactions until sales of Pradaxa slowed. Now Xarelto is the drug most often associated with safety concerns.
Since injuries and deaths associated with Xarelto have only recently been identified, only a few lawsuits against Bayer and Janssen Pharmaceuticals have been filed to date. Claims for compensation are expected to increase as injuries and deaths related to the drug continue to mount.
Eliquis: The Newest Anticoagulant
The most recent anticoagulant to enter the market is Eliquis (apixaban). The drug was developed jointly by Pfizer and Bristol-Myers Squibb. The FDA was expected to approve Eliquis in 2012 but it delayed its approval until this year. The drug is approved for the treatment of pulmonary embolisms and deep vein thrombosis.
Like all anticoagulants, there is a risk that Eliquis will produce internal bleeding. Since Eliquis is just entering the market, there is no way to know whether Eliquis will cause fewer problems than Pradaxa and Xarelto. Patients should bear in mind, however, that Eliquis shares the most serious problem associated with the other two drugs: the lack of an antidote that will reverse its anticoagulant effects. An article in the Cleveland Clinic Journal of Medicine places Eliquis in the same risk category as Pradaxa and Xarelto, noting that doctors have serious difficulty managing the internal bleeding that the three drugs produce.
What Patients Should Do
If you have been prescribed one of the new anticoagulants, discuss the risks and benefits with your doctor. Make sure you understand why the doctor is prescribing the new drug rather than Warfarin. Ask how the doctor plans to manage your condition if you experience uncontrollable bleeding. If you are not satisfied with your doctor’s answers, it never hurts to get a second opinion.
If you have experienced internal bleeding and have been hospitalized, or if internal bleeding caused a family member to die, and if the bleeding was caused by Pradaxa, Xarelto, or Eliquis, you may be entitled to compensation for your losses, including medical expenses, pain, emotional anguish, and disability. A personal injury attorney who represents individuals injured by medications can evaluate your case and tell you whether you can pursue a claim. You should act promptly, however, to avoid losing your right to seek compensation due to the passage of time.