Pradaxa presents a risk of excessive bleeding, but so does every blood thinner. Anticoagulants work by inhibiting blood’s ability to clot; even a minor bleed can cause irreversible damage when the body has lost its capacity to staunch the flow.
But unlike warfarin, an effective anticoagulant in use for more than 60 years, Pradaxa’s approval was not accompanied by an antidote. In fact, it was not until October 2015 that a reversal agent for the drug was released for emergency bleeding situations.
Pradaxa Bleeding Risks
Early clinical trials, including the RE-LY study upon which Pradaxa was approved, suggested that the new blood thinner’s risks were lower than those presented by warfarin.
But only two years after the drug’s approval, almost 1,000 deaths were being blamed on Pradaxa, and the cause was clear: irreversible bleeding.
Recent research has only substantiated the link between Pradaxa and increased bleed risks, and rigorous analyses have called RE-LY’s initial results into question.
Real-World Research Finds Higher Risks Than Warfarin
Some critics have noted that RE-LY’s findings may have come from an “artificial setting”: most patients included in the clinical trial were younger than actual Pradaxa users, and had fewer additional conditions that increase the risk of bleeding.
As a result, they argue, the trial tended to minimize Pradaxa’s true bleeding risks. Even so, and despite its “artificial” patient population, the RE-LY study still found a significant increase in the rate of excessive gastrointestinal (GI) bleeds over warfarin. Among RE-LY’s 19,113 patients with atrial fibrillation, 1.1% of the people taking warfarin suffered major GI bleeds. 1.6% of the patients on Pradaxa did.
A new University of Pittsburgh study, published by the Journal of the American Medical Association in early 2015, attempted to look head-on at the “real world” clinical use of Pradaxa.
Researchers took a random sample of Medicare patients, 5% of the national total. Then the team identified patients with atrial fibrillation, the primary condition Pradaxa is approved for and monitored the progress of two groups: people on Pradaxa and people on warfarin.
Patients taking Pradaxa were 30% more likely to suffer a bleeding event of any kind and 58% more likely to suffer a major bleeding event.
But the 2015 study identified an even higher risk in relation to gastrointestinal bleeding: patients on Pradaxa were 85% more likely to suffer GI bleeds than those on warfarin.
Bleeding in the esophagus, intestines, stomach, rectum and anus: the new wave of oral anticoagulant drugs has been repeatedly shown to increase a patient’s risk for severe gastrointestinal bleeds.
A 2013 meta-analysis of four Pradaxa studies found the drug increased patients’ risk of GI bleeding by 41%, in contrast to an FDA review of insurance records that found no such increase.
More recently, a Mayo Clinic study completed in January 2015 found that under the age of 75, patients on warfarin experienced a similar rate of gastrointestinal bleeding as those on Pradaxa. But after turning 75, the rate of GI bleeding among Pradaxa patients shot skyward, while warfarin’s risk actually decreased slightly.
While any bleeding event, whether external or internal, may be exacerbated by Pradaxa’s anticoagulant effects, researchers have identified another particular area of concern in addition to the gastrointestinal tract: the brain.
Pradaxa is intended to decrease the risk of stroke, but only a particular kind: ischemic stroke, when a blood clot blocks a blood vessel supplying the brain with oxygen. With its only source of vital nutrients stopped up, brain tissues can quickly die, leading to irreversible damage or death.
But new anticoagulants may present an increased risk of hemorrhagic stroke, in which uncontrolled bleeding within the brain damages brain tissue. This form of stroke is also called intracerebral hemorrhage.
Who Is Most At Risk?
Age is a primary risk factor for atrial fibrillation; generally, the older a person is, the more at risk they are for developing Afib. Pradaxa’s bleeding risks also seem to increase with patient age.
With impaired kidney function and lower weight, the aging body finds it more difficult to flush Pradaxa out, potentially increasing the drug’s anticoagulant effects and thus the risk of an excessive bleed.
Until October 2015 the only way to reverse Pradaxa’s effects is through dialysis, by mechanically filtering the drug out of a patient’s blood. Inhibited renal function makes this more difficult, meaning older patients may be left to bleed, even under a physician’s expert care.
Risks Lead To Legal Action
Pradaxa had no antidote, no reversal mechanism other than dialysis, which can take up to 2 or 3 hours to flush just 60% of accumulated Pradaxa from the blood stream. Those 2 or 3 hours become particularly precious in the event of excessive bleeding.
Between 2012 and 2014, thousands of patients filed Pradaxa lawsuits, claiming Boehringer Ingelheim had failed to adequately notify patients and healthcare professionals that Pradaxa lacked a reversal agent.
Those legal claims have now been settled. In May of 2014, Boehringer Ingelheim agreed to settle most of the lawsuits for a total of $650 million.
But there are patients, harmed by Pradaxa, who have yet to be compensated.
Patients May Still Be Able To File Lawsuits
Banville Law has joined an alliance of distinguished attorneys to investigate new Pradaxa claims. Our experienced lawyers are devoted to protecting patient rights and have turned their full attention to holding large drug companies accountable for potentially dangerous products.
If you were prescribed Pradaxa and experienced a major bleeding event, contact Banville Law today for a free consultation. Speak with one of our lawyers to learn more about your own case eligibility. It’s free and comes with no obligation.
We believe no one should go without experienced legal counsel. That’s why our attorneys offer their services on a contingency-fee basis: you pay nothing until we win compensation in your claim.