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Pradaxa and Warfarin and are both anticoagulants that inhibit the blood´s ability to clot. However, Pradaxa and Warfarin perform this job in different ways. Warfarin interferes with chemical reactions that are dependent on vitamin K. Pradaxa on the other hand, works by attaching to thrombin (a clotting agent) so that it cannot attach to anything else.
While the end result of both Pradaxa and warfarin is decreased clotting, warfarin has the significant advantage of being reversible. If a patient starts bleeding or warfarin´s effects need to be reversed for any other reason, doctors have many options to do so. One common approach is administering vitamin K. The vitamin K overrides the effects of warfarin, and blood clots as it normally would.
In contrast, Pradaxa has no readily available reversal agent. Instead, patients must wait for the drug´s effects to naturally wear off as the body processes it. This leaves patients in danger of bleeding out even in an emergency situation.
Further complicating the lack of a reversal agent is that the kidneys mostly process Pradaxa. This means that many patients, including those with impaired kidney function, may take even longer to fully remove Pradaxa from their bodies.
The FDA approved Pradaxa in October 2010 to prevent strokes and blood clots in people with atrial fibrillation, or irregular heartbeat. Boehringer Ingelheim, the Pradaxa manufacturer, marketed the medication as performing better than anticoagulant warfarin, which has been used since 1954 but requires frequent blood tests and imposes other restrictions on patients’ lives. Warfarin is prescribed to 50% of the Americans with atrial fibrillation on anticoagulation therapy, while 30% of patients use Aspirin.
Warfarin is decidedly inconvenient, requiring dietary restrictions, frequent blood sampling, and overall regular monitoring and dose adjustments. However, it is also both effective and reversible. Meaning that if a patient begins to bleed out or their blood levels dip into a dangerous range, physicians can use Vitamin K, plasma, and blood factors to reverse the anticoagulation of warfarin.
In direct contrast, Pradaxa is extremely convenient. Boehringer Ingelheim marketed its blood-thinner as not requiring any medical monitoring, including a lack of pesky blood draws. The problems with this are two-fold. First, the levels of Pradaxa cannot be adequately monitored with blood testing, so doctors will generally have an incomplete picture of a patient’s health while on the medication. Second, per its own label, a specific reversal agent for Pradaxa is not available. This means that if a patient starts to bleed out or suffer from another dangerous medical problem, the effects of Pradaxa in their system cannot be timely reversed. The only reversal option for Pradaxa is emergency dialysis, a very unrealistic option for most patients, especially those suffering from acute trauma or in the process of bleeding out.
Roughly 2 million people take blood thinners to prevent blood clots from forming and causing a heart attack or stroke. Warfarin is the most commonly prescribed anticoagulant, and 31 million prescriptions were written for the drug in 2004. With over 50 years of patient use, warfarin is by far the safer choice. Starting very soon after its release, Pradaxa caused a statistically significant number of life-threatening adverse events to be reported worldwide.
Moreover, trauma is the fourth-leading cause of death in the United States. When a trauma patient is on a blood thinner, their treatment must be modified. The degree of warfarin anticoagulation can be easily assessed, allowing for such modification in treatment. No such tests exist for Pradaxa. Furthermore, there are strategies to rapidly reverse the anticoagulation effect of warfarin using Vitamin K, plasma factor VIIa, and factor concentrates. Coagulation is largely irreversible in patients taking Pradaxa. While Boehringer Ingelheim may be working on an antidote to reverse Pradaxa’s effects, for now if a trauma patient comes in, their blood levels cannot be adequately assessed and real harm will often result.
If you or a loved one took Pradaxa and suffered adverse effects, you may be entitled to compensation. Talk to an attorney from Raizner Slania today. Our attorneys have extensive experience handling complex injury litigation, and can help evaluate your options.