Pradaxa, also known by its generic name dabigatran, is used as a preventative treatment to reduce the risk of stroke and blood clots in people who have atrial fibrillation. Atrial fibrillation is the most common type of arrhythmia, or irregular heartbeat. Pradaxa helps to prevent blood platelets from clotting together, which, if occurs, can create a blockage in the vein. Pradaxa can also be used to treat blood clots in the veins found in legs or lungs and can reduce the risk of their reoccurrence. Pradaxa was approved in October 2010 and immediately proved strong competition to the popular blood thinner already on the market, warfarin. Pradaxa began gaining popularity as it was found that it requires less maintenance than warfarin, which requires regular trips to the doctor, blood tests and diet restrictions. Additionally, Pradaxa was advertised to have fewer, less severe side effects than warfarin, whose negative effects include brain hemorrhages and internal bleeding. In clinical trials, Pradaxa did in fact outperform warfarin. More and more patients with atrial fibrillation began to fill prescriptions for Pradaxa partially accredited to the promotion of the drug by Boehringer Ingelheim, its German manufacturer. In 2011, Boehringer Ingelheim put $464 million into promoting Pradaxa, and in the first quarter of the next year, sales had already reached $209 million. The anticoagulant drug was growing rapidly, with minimal negative feedback initially. However, a few short years after its entrance into the pharmaceutical market, patients began reporting numerous cases of hemorrhaging and uncontrollable bleeding which contributed to more than 500 deaths. Both Pradaxa and warfarin have positive and negative side effects, but recently Pradaxa has been highlighted in the news for several of its lethal side effects. In March 2012, a Cleveland Clinic study found that Pradaxa causes a 33 percent increased risk of heart attack or severe symptoms of heart attack when compared with warfarin. Bleeding is always a risk factor to be conscious of when taking blood thinners. However, Pradaxa is especially risky because once excessive bleeding stops, it cannot be controlled. Because warfarin functions differently from Pradaxa, excessive bleeding can be controlled for patients taking warfarin by administering vitamin K. Pradaxa does not have an antidote like warfarin does, which makes fatal hemorrhaging more likely on Pradaxa.
With these reports of negative side effects while taking Pradaxa came over 4,000 state and federal lawsuits, to which Boehringer Ingelheim responded by compensating $650 million to patients and families. This is an average of about $162,500 for each claimant. 2011 was a notorious year for the drug in which 540 patients died from the side effects of Pradaxa and thousands of others experienced serious side effects. The drug manufacturer was forced to provide some sort of physical compensation for the consequences of its drug. However, the company still lacked much moral concern for the issue. Although Boehringer Ingelheim awarded a decent some to all of its customers, the company failed to take any responsibility for the injuries and deaths that were caused by its drug. In a statement made by Andreas Neumann, head of the Legal Department and general counsel for the manufacturer, he states, “We continue to stand resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked any merit”.
If you or a loved one has taken Pradaxa and has suffered from some of the debilitating side effects of the drug, call the drug injury lawyer of Altman & Altman LLP, for a confidential case evaluation.
“Boehringer Ingelheim to Settle 4,000 Pradaxa Lawsuits for $650 Million.” DrugWatch. N.p., 1 Oct. 2015. Web. 03 June 2016.
“Pradaxa – Uses, Bleeding Side Effects, Lawsuit Payout & Settlement.” DrugWatch. N.p., 16 Oct. 2015. Web. 03 June 2016.