Despite recent advances in heart patient medications, research has been shown that those prescribed Pradaxa are at greater risk of deadly side effects than risks posed by its predecessor, Warfarin. Intended to prevent strokes in patients with an irregular heartbeat called atrial fibrillation, Pradaxa was designed to circumvent the possibility of brain hemorrhages and other dangerous bleeding, risks heavily associated with Warfarin. However, several doctors have expressed similar concern with Pradaxa side effects. They say its real world use raises concern about the risk of Pradaxa stroke and serious bleeding if not taken properly, particularly in patients with poor kidney function. Nearly two dozen U.S. federal Pradaxa lawsuits have been filed against Boehringer Ingelheim, the drugs maker, alleging such harm. In the worst cases, Pradaxa patients showed up with minor puncture wounds at emergency rooms and bled to death because Pradaxa has no antidote to stop the bleeding. Warfarin, on the other hand, does have an antidote. Vitamin K will stop bleeding in Warfarin patients.
Doctors face several challenges when administering Pradaxa outside the control of clinical trials, as physicians have to determine themselves what the follow – up plan will be following its prescription. Failure to test patient kidney function can compound the problem even further, as 80 percent of the drug is excreted in the organ. Weak kidneys allow the medicine to build to unsafe levels in the bloodstream, often resulting in severe internal bleeding. Given that no specific antidote exists to reverse such pradaxa bleeding, overlooking patient kidney function is potentially life – threatening. According to Dr. Kenneth Bauer, head of hematology for the Veterans Administration health system in Boston, the FDA should have never approved Pradaxa for patients with severe kidney dysfunction, as such patients were excluded from large studies. In light of such findings, doctors have been hesitant to switch their patients from Warfarin to Pradaxa.