The American Bar Association (“ABA”) Journal reports that so far, over 100 cases have been filed in federal courts across the nation over bleeding risks associated with the blood thinning medication Pradaxa. According to the Pradaxa website, Pradaxa is a prescription blood-thinner used to resuce the risk of blood clots that cause strokes for persons with atrial fibrillation not caused by a heart valve issue. The Mayo clinic website defines atrial fibrillation as an irregular heartbeat.
The New York Times reports that Pradaxa, a highly successful drug that has generated over $1 billion in sales, has also been linked to over 500 deaths in the United States. Pradaxa, which was introduced in 2010, was the apparent replacement to Warfarin, a similar drug used to prevent strokes. The benefit to Pradaxa was that Warfarin required meticulous monitoring of the patient, including blood tests and dietary restrictions, while Pradaxa requires no such supervision. Many doctors and others in the medical community feel that the approval process was not rigorous enough because it was approved without an antidote in case of catastrophic side effects. Unfortunately, these side effects have caused hundreds of patients to bleed to death without any antidote to cure them. The patients at the highest risk of bleeding to death include those with kidney problems and the elderly and if you do experience internal bleeding due to Pradaxa, there is currently little to nothing doctors can do to save you.
The ABA Journal reports that so far, 131 Pradaxa cases have been filed, with 120 filed in the Southern District of Illinois alone. The lawsuits cite the lack of antidote and inadequate warnings of risk as the cause of wrongful deaths and injury. Due to the lack of antidote, this highly prescribed drug will likely see thousands more cases filed against it in the near future. Boehringer Ingelheim, the manufacturer of Pradaxa, cites in its defense a large clinical trial where patients died at roughly the same rate as patients prescribed Wafarin. The company also cites a Food and Drug Administration report that found that Pradaxa did not cause a higher risk of bleeding than Wafarin. Despite these defenses, it is likely that Pradaxa will at least have to increase its warnings and better inform doctors and patients about the bleeding risks associated with its drug.
The product liability attorneys at our Chicago office have been following these Pradaxa lawsuits closely and understand just how serious the lack of adequate warnings are to thousands of patients that take Pradaxa in Illinois and across the country. If you are currently prescribed Pradaxa, and you have either kidney issues or are elderly, speak with your doctor to make sure that Pradaxa is the right choice for you. Without an antidote, any complication from Pradaxa is life threatening. If you or a loved one has taken Pradaxa and experienced fatal blood thinning or other blood complications from the medication, please contact our offices to better understand your legal rights.