The introduction of new drugs into the marketplace is common. In recent years, however, new blood thinners have entered the marketplace, which is rare. It has been decades since a new anti-coagulant gained approval for widespread use. Two popular drugs, Xarelto, and Pradaxa were introduced to consumers. Their manufacturers aggressively marketed them as easier and safer anti-coagulants than warfarin (often called by the brand name Coumadin), which has been the blood thinner of choice since the mid 1900s. Coumadin has been far from controversial, although taking the medication is not without inconvenience. Janssen pharmaceuticals, a division of Johnson & Johnson that manufactures Xarelto, claims that Xarelto is a much better alternative to Coumadin.
There has been a new Canadian study, however, that calls these claims into question. The study challenges the notion that these new medications have any safety advantages over warfarin. The study also suggests that, although Pradaxa and Xarelto are marketed as requiring less strict monitoring, this hands-off approach may not be the safest one. The safety of Xarelto is at the center of several lawsuits currently pending against the manufacturer. If you have been injured by Xarelto, call our Birmingham, Alabama attorneys for help. Farris Riley & Pitt have the experience you need to receive compensation for your injuries.
The study conducted by Southlake Regional Health Centre in Ontario, utilized data from over 900 patients. The patients received Xarelto, Pradaxa or warfarin after a heart procedure. Researchers looked at the number of side effects including strokes and bleeds. The Canadian Journal of Cardiology published the results. The study showed that the risks of side effects were the same for each drug. The risks of the new drugs like Xarelto were the same as the risks of warfarin.
Xarelto Marketing Claims to Lower Bleeding Risks
Xarelto has been aggressively marketed as being safer than warfarin. One of its most significant selling points has been that patients, who take Xarelto to treat atrial fibrillation, are less likely to suffer from a bleeding event. Manufacturers claim that the new drugs posed less of a risk of a hemorrhage or other bleeding complication than warfarin. This study certainly challenges this claim. There is additional research questioning this as well. It is unclear that Xarelto provides and additional safety to a patient than its predecessor warfarin, the less expensive choice.
Xarelto Safety May Improve With Close Patient Monitoring
Xarelto and Pradaxa were both also marketed as being significantly more convenient to take than warfarin. Warfarin always demanded that the patient stick to a careful diet, submit to frequent blood monitoring and more. The new anti-coagulants claim that there is no such monitoring or dietary restriction requirement. Some say that this “convenience” factor was aggressively marketed to doctors and patients alike. Supposedly, Xarelto is much easier for health care professionals and consumers alike. Research suggests, however that for people who take these anti-coagulants, patient monitoring may reduce the risk of potential bleeding problems.
There is No Stopping a Xarelto Bleed
The risk of bleeding associated with Xarelto, Pradaxa and warfarin was essentially the same according to the study. All blood thinners, however, present at least some risk of bleeding or hemorrhage. Their very nature alone contributes to that risk. With warfarin, if a patient experiences a bleed, even a life-threatening one, the bleed could be stopped with a dose of vitamin K. Vitamin K quickly and easily reverses the “thinning” effects of warfarin. As of January 2015, there is no such approved reversal agent to help patients taking Xarelto. In the event of a life threatening bleed, where time is of the essence, there is no way to stop the effects of the drug.
The results of the Canadian study do call into question whether the benefits of the “new generation” of blood thinners can be substantiated. Even if there were some benefits to choosing medications like Xarelto over warfarin, we must ask whether those benefits are outweighed by the fact that there is no antidote if needed.
That there is no reversal agent for Xarelto and Pradaxa is one of the subjects of several lawsuits that have been filed over the drugs. In fact, BoehringerIngelheim Pharmaceuticals, Inc., who manufacture Pradaxa, recently settled approximately 4 thousand lawsuits that were filed against them based on complications patients experienced while taking the drug-some of which resulted in death. They agreed to pay $650 million dollars to settle the cases.
Bayer and Janssen, the makers of Xarelto, face similar lawsuits. The numbers are growing, and they contain claims similar to those in the Pradaxa cases. In December 2014, an order was issued establishing a Xarelto MDL and consolidating the cases in the U.S. District Court for the Eastern District of Louisiana. If you think you have a claim against the manufacturer of Xarelto, it is important that you contact experienced attorneys in Birmingham, Alabama. Farris Riley & Pitt will work hard to help you obtain compensation for your injuries.