Pradaxa was approved by the U.S. Food and Drug Administration (FDA) in October of 2010. However, since that time, medical professionals have become increasingly alarmed about irreversible bleeding that can occur in patients taking the blood thinner Pradaxa (generic name dabigartran). The FDA has been reviewing the drug since December of 2011, because of these concerns of medical professionals.
Pradaxa was expected to replace Coumadin, (generic warfarin), to prevent blood clots in stroke patients with atrial fibrillation or abnormal heart rhythm. However, unlike Pradaxa, medical professionals are able to stop bleeding that may occur in patients taking Coumadin by simple, basic medical measures. Coumadin patients generally are treated with Vitamin K injections to stop bleeding. Because Coumadin requires continual monitoring, Pradaxa has marketed itself as a way of lowering healthcare costs and improving patient lifestyles by not requiring the continual monitoring associated with Coumadin. This kind of continual monitoring requires frequent blood draws and checks-ups with health care providers, and carries with it additional safety risks that raise the cost of healthcare.
Clinical trials of Pradaxa concluded in 2009. Results from these trials showed Pradaxa to be more effective in stroke prevention than Coumadin, and that the risk of hemorrhagic bleeding in patients taking the medications is about the same. However, it is important to understand that there is no antidote for hemorrhagic bleeding in patients taking Pradaxa, and these patients are at a much more serious risk for serious bleeding complications than exists for Coumadin patients.
Why Pradaxa Causes Uncontrollable Bleeding
Pradaxa is included in a class of drugs known as direct thrombin inhibitors. These drugs affect the end of the enzymatic cascade that causes blood to clot. Unlike all other blood thinners, treatment to induce normal clotting is not effective in patients taking Pradaxa. The reason for this is that Pradaxa is filtered out of the body through the kidneys, so the only way to remove the drug from the body is through dialysis. This process takes approximately 2 to 3 hours and only 35% to 50% of the drug can be removed.
Additionally, the difficulty in diagnosing a condition exacerbated by Pradaxa use may result in a delay in implementing a dialysis regimen, which may preclude successful treatment. Furthermore, even once implemented a dialysis regimen may not be able to timely remove sufficient quantities of Pradaxa from the blood to be effective in treating the patient.
The fact that no immediately effective antidote exists to stop hemorrhagic bleeding occurring in patients taking Pradaxa poses a serious health risk to the elderly and any other individual taking this drug. Even minor falls — a common event among the elderly and general population — can cause uncontrolled bleeding or hemorrhages, which could prove fatal.
If you or a loved one has suffered serious bleeding or hemorrhaging while taking Pradaxa, you may have valuable legal rights. To learn how our lawyers can help you file a Lawsuit to recover damages incurred from being a victim of bleeding or hemorrhaging from taking Pradaxa, please fill out our online form or call (877) 444-2929.