Pradaxa patients exposed to higher cardiac risks, uncontrollable bleeding
Boehringer Ingelheim’s anti-clotting drug Pradaxa has been widely hailed in the medical community as a long-anticipated alternative to the 54-year-old drug warfarin, but recent studies confirm the newcomer drug may put patients at higher risk of heart attack and other adverse events.
In 2009, a Pradaxa study called RE-LY found that while the drug lowered the stroke risk by 34 percent in patients with atrial fibrillation compared to patients taking warfarin, the chances of having a heart attack for those patients went up slightly.
To understand whether this heart attack risk was real, Cleveland Clinic doctors combined the data from six other Pradaxa studies and looked for red flags. This collective data showed that across the board, Pradaxa patients do indeed face greater probability of having a heart attack over warfarin patients.
Out of 20,000 Pradaxa patients in the combined trials, 237 suffered coronary events, compared to 83 out 10,514 warfarin patients.
But slightly higher risk of heart attack may not be the most troubling side effect that has come to light since the drug became available in 2010. Pradaxa has also been linked to unstoppable hemorrhaging in some patients, a risk that could turn ordinary falls and other accidents into potentially fatal events.
For example, University of Utah physicians published a report about an 83-year-old man who checked into the emergency room after falling from standing level. The man, who had started a Pradaxa regimen for an irregular heartbeat one month prior, was bruised and shaken up but perfectly coherent and oriented. His condition, however, steadily declined and he died within hours.
Scans revealed bleeding in his brain, which doctors were unable to stop because there is no known agent that can reverse Pradaxa’s blood-thinning effects. The only known treatment for out-of-control bleeding in Pradaxa patients is kidney dialysis, which takes several hours and can strain the heart, making it ineffective and even dangerous for Pradaxa patients experiencing hemorrhaging.
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