Pradaxa (dabigatran) is a blood thinner produced by Boehringer Ingelheim, was approved by the FDA in 2010 and has been prescribed to over 850,000 patients in the United States. The drug is primarily used for those who have atrial fibrillation, deep vein thrombosis, or pulmonary embolism to prevent the formation of blood clots. The report in question focuses on people suffering from atrial fibrillation, an abnormal heart rhythm that increases the risk of stroke. According to the FDA, over 3 million Americans have this condition.
Prior to the 2010 FDA approval, many atrial fibrillation patients used Warfarin (Coumadin, Jantoven) to thin their blood to lower their risk of stroke. Warfarin requires frequent blood testing to ensure the levels are correct. Pradaxa was approved by the FDA without the need for frequent blood tests after clinical trials involving over 50,000 patients. Pradaxa’s convenience appealed to consumers, who shell out about $300 a month for the medication, compared to $4 a month for a generic version of Warfarin.
However, doctors began reporting a larger number of serious and sometimes fatal bleeding problems in older patients on the drug beginning in 2012. Though the drug manufacturer claimed that Pradaxa required no blood-level monitoring, the company had data showing the amount of anticoagulation (blood thinning) varied from patient to patient. This meant that the same dose of Pradaxa could produce widely varying effects on blood clotting.
The British Medical Journal revealed that Boehringer Ingelheim withheld their findings from U.S. and European regulators. The company maintains that the conclusions drawn from their clinical trials supports their claim that no blood level monitoring is needed. So far, the FDA has not withdrawn their approval of Pradaxa.
Pradaxa has been attributed to 542 deaths and nearly 2,400 hemorrhages in 2011, compared to Warfarin’s 72 deaths in the same year.
If you or a loved one has suffered from taking Pradaxa, please contact us to discuss potential legal claims you may have against the drug manufacturer. In some cases, filing a lawsuit is the only way to recoup money spent on hospital expenses, lost wages, and funeral costs.