Pradaxa Bleeding Reports Raise Doubts on FDA Drug Approvals
Pradaxa, a blockbuster blood thinner marketed by Boehringer Ingelheim, has been linked to more than 500 deaths, most of which resulted from serious episodes of Pradaxa bleeding. According to a report from The New York Times, some doctors and patient advocates are now complaining that the U.S. Food & Drug Administration (FDA) approval process is not sufficiently rigorous because it allowed Pradaxa to come to market, even though it lacked a reversal agent for the serious, life-threatening bleeding that can be a side effect of any blood thinner.
According to the Times, Pradaxa was launched on the U.S. market in October 2010, and was supposed to replace warfarin, a 60-year-old blood thinner, as the first line treatment for preventing blood clots in people who suffer from atrial fibrillation. As the Times points out, warfarin requires patients to follow strict dietary restrictions and undergo frequent blood tests to ensure it’s working right. While Pradaxa requires neither, there’s no way to easily reverse Pradaxa bleeding. Warfarin bleeding, on the other hand, can be reversed via the administration of vitamin k.
Despite this lack of a reversal agent, Pradaxa took off, and by the end of 2011, 17% of atrial fibrillation patients in the U.S. were being treated with the new drug, according to the Times. But during the same time, Pradaxa was the main suspect in 542 patient deaths reported to the FDA, and was linked to more reports of injury or death than any other drug monitored by the Institute for Safe Medication Practices. Emergency room doctors interviewed by the Times also said they were starting to see Pradaxa patients suffering from life-threatening hemorrhaging during the same time period.
“You feel helpless,” Dr. Bryan A. Cotton, a trauma surgeon in Houston, told the Times. “And that’s a very bad feeling for us.” According to Dr. Cotton, Pradaxa has contributed to the bleeding deaths of at least eight patients at his hospital.
The FDA, which launched a Pradaxa safety review in December 2011, recently reported that it had not found a higher risk of bleeding for patients taking Pradaxa compared to those treated with warfarin. But the FDA did not address the lack of a reversal agent for Pradaxa bleeding. Critics told The New York Times that the problems we’re now seeing with Pradaxa are a good illustration of what can happen when a drug at that performs well in tightly controlled trials is put to real-world use. They expressed shock that the FDA decided to unleash Pradaxa on the public, even though there is no effective reversal agent for internal bleeding.
“The practical experience is that once hemorrhagic complications occur in this drug, it is much more likely to be a catastrophe than with Coumadin,” said Dr. Richard H. Schmidt, an associate professor of neurosurgery at the University of Utah, who treated an 83-year-old Pradaxa patient last year who died from internal bleeding following a bump to the head.
Boehringer Ingelheim, which said it was working on an antidote for Pradaxa bleeding, has recommended dialysis in such patients to flush the drug from their body. But according to Dr. Cotton, that approach isn’t realistic, and even the drug maker acknowledges that “the amount of data supporting this approach is limited,” the Times said.
Scores of lawsuits have now been filed by people who allege they suffered serious and life-threatening episodes of Pradaxa bleeding. If you or a loved one experienced such an injury, you may be eligible to file a Pradaxa lawsuit seeking compensation for your pain and suffering. To learn more, please contact the Pradaxa lawyers at Bernstein Liebhard LLP today by calling 1-877-779-1414.