The prescription drug Pradaxa, an anticoagulant (or blood thinner), has reportedly been linked to internal bleeding that, in some cases has allegedly caused hospitalization and even death. Lawsuits have been filed by Kentucky Pradaxa Attorneys based on injury and death of patients that have also been prescribed dabigatran, known as Pradaxa.
Pradaxa was approved by the US Food and Drug Administration (FDA) in October 2010, in hopes that it would replace another blood thinner with severe side effects, warfarin, also known as Coumadin. The drug is prescribed to prevent strokes and blood clots in patients with atrial fibrillation. In November 2012, despite evidence to the contrary and the many Pradaxa lawsuits, the FDA claimed that Pradaxa was “no more likely to cause bleeding than other anti-coagulants.” However, in December 2012, the FDA issued a warning that Pradaxa should not be used in patients with mechanical prosthetic heart valves as a clinical trial in Europe discovered those patients were at a higher risk of stroke, heart attack and blood clots than patients taking warfarin.
No Antidote After Bleeding Begins
One of the biggest alleged problems with Pradaxa is that if a patient develops internal bleeding, there is no way to reverse the blood-thinning affects like there is with warfarin. Some patients who begin to bleed internally have reportedly bled to death in emergency rooms and hospitals, as there is no way for physicians to stop the bleeding. The drug has been linked to over 500 deaths throughout the United States, as well as many more injuries as patients can attest. In one Pradaxa lawsuit, at least one woman was alleged to have suffered severe gastrointestinal bleeding. In January 2013, another Kentucky woman filed a lawsuit in US District for the Southern District of Illinois after she suffered a cerebral hemorrhage after taking the drug. The lawsuit was filed in Illinois, despite the fact that the victim lived in Kentucky, due to a multidistrict litigation transfer order by a US District Court Judge. Because Pradaxa has no antidote, typical treatments for bleeding such as intravenous fluids and a protein known as recombinant factor are often useless in treating patients taking the blood thinner.
The main differences between Pradaxa and warfarin are that patients on warfarin have strict dietary and lifestyle changes that must be followed while on the drug. In addition, patients require close monitoring and blood tests, while Pradaxa requires none of those. Many doctors are claiming that Pradaxa may work well in the clinical setting, but in a real world setting, they are finding that the drug causes significant risk in patients who may not recognize internal bleeding, or who may develop serious bleeding after a minor injury.
Mechanical Prosthetic Heart Patients
In a Canadian study, doctors reported that mechanical prosthetic heart patients who were successful on warfarin suffered from valve thrombosis after being switched to Pradaxa. There was no warning on Pradaxa that it could not be used in patients with such heart valves, further indicating the possible dangers of the drug. Even though the drug is not approved for use in the United States in patients with such conditions, doctors may prescribe the drug, unaware that there is the increased risk of heart attack, stroke and blood clots.
More Deaths Reported From Pradaxa Than Warfarin
According to the Institute for Safe Medication Practices, 542 reports of death from Pradaxa were reported to the FDA in 2011, more than any other medication. The FDA only received 72 reports of deaths for patients who were taking warfarin, yet the agency reportedly continues to insist that the benefits of the drug far outweigh the risks, increasing the possibility of further Pradaxa lawsuits.
At this time Boehringer Ingelheim Pharmaceuticals, the manufacturer of Pradaxa, insists that the drug is no more dangerous than warfarin and no requirements have been issued by the FDA to include the fact that there is no antidote for the drug should bleeding occur. Families of patients who have died and those who have been injured after taking the drug claim that there was no warning about the possibility of extreme internal bleeding before they suffered their injury. Kentucky Pradaxa Attorneys have also noted that doctors have expressed concern at the lack of monitoring required for a drug with such significant and dangerous side effects, believing that Pradaxa may need further study to determine if the effectiveness of the drug truly outweighs the risk of patients who take it.
Kentucky Pradaxa Attorneys Can Help
If you or a loved one has suffered injury, or if a loved one has died, after taking Pradaxa, contact Kentucky Pradaxa Attorneys at Attorney Group for Kentucky. We can answer any questions you may have at no cost to you, and can help clarify what legal rights you may have. We will also connect you with Kentucky Pradaxa Attorneys that can handle your case and help you pursue compensation for damages you may have suffered possibly due to Pradaxa. So contact Attorney Group for Kentucky today for your free consultation.
For more information, see our Pradaxa Lawsuit Help Center