The controversy over the popular blood-thinning drug Pradaxa is reaching new heights after a slew of negative articles and editorials. The highly-esteemed British Medical Journal (BMJ) recently published reports criticizing the data used to support the safety and efficacy of the drug, along with the suspect behavior of those who were apart of the approval process.Pradaxa attorneys at Pintas & Mullins Law Firm are happy to see critics finally speaking out.
Pradaxa is an oral tablet commonly prescribed to patients at risk of heart attack and stroke, and is manufactured by Boehringer-Ingelheim. It is intended to thin the blood to reduce the risk of blood clots, which is known as anticoagulation. Pradaxa is a new type of anticoagulant (in the same class as drugs like Eliquis and Xarelto), and was thought to eventually replace warfarin, the original anticoagulant that has been used for more than 60 years.
The problem with warfarin is how strictly patients must be monitored while on it; patients prescribed to Pradaxa, on the other hand, do not need to be monitored as closely, making it seem like a simpler treatment. It is becoming increasingly clear, however, that the “simpler treatment” strategy is actually a red herring.
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As the investigative editor for the BMJ points out, Boehringer-Ingelheim failed to disclose all of the information it had on Pradaxa and its risks to the FDA. Among the undisclosed finding included the actual amount of life-threatening bleeding situations, and the dose that could prevent such an accident from occurring.
Other information not previously released by the drugmaker related to the amount of monitoring that would be necessary to achieve the right doses in patients. The main reason doctors would prescribe Pradaxa over warfarin is because the company promised that the same anticoagulating effects could be safely achieved in patients without routine monitoring. As it is turning out, this does not seem to be the case.
No Antidote for Pradaxa
Despite all of this, the worst and most dangerous side effect of Pradaxa is the likelihood of suffering a major bleeding event, as there is no reversing agent for the drug’s blood-thinning effects. For patients on warfarin, a dose of vitamin K can quickly and safely reverse the drug, giving blood the ability to clot and stop bleeding. If a patient on Pradaxa starts to bleed, even if they are immediately hospitalized, there is no way for doctors to stop the bleeding. Too many patients have died on hospital beds while doctors and nurses stood helplessly by.
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Pradaxa is also a brand-name drug, and much more expensive than warfarin. The evidence against the drug continues to pile on, and doctors throughout the country are beginning to see this. Particularly doctors in emergency and trauma departments, who have been opposed and skeptical of the drug from the start after seeing many bad bleeds in Pradaxa patients. As information against Pradaxa slowly leaks out, it becomes increasingly clear that Boehringer-Ingelheim knew about the risks and simply hid them to gain approval.
This is the basis of the recent lawsuits filed against the drugmaker, who marketed the drug as a “one size fits all” for all patients. In reality, the elderly and those with compromised kidney functions are actually have higher risks of major bleeding. Boehringer-Ingelheim recently announced that it would pay $650 million to settle the 4,000 lawsuits currently pending against it, which averages out to about $162,000 for each claimant.
If you have any questions about Pradaxa bleeding and this recent major settlement, contact our firm immediately. Our Pradaxa lawyers offer free, confidential case reviews, and we help clients in all 50 states. Do not let companies like Boehringer get away with this kind of malicious behavior; it must be held accountable for the deaths and serious injuries caused by Pradaxa.