Pradaxa is a blood thinning medication prescribed and marketed to patients with a heart condition called non-valvular atrial fibrillation--it is used to reduce the risk of strokes, blood clots and systemic embloisms. Pradaxa is similar to a drug called Coumadin (aka Warfarin) which has been on the market for several decades. The FDA is currently investigating reports of severe bleeding events in patients taking Pradaxa. In fact the FDA Website indicates that it is evaluating post marketing reports of serious bleeding events in patients taking Pradaxa. The FDA website says that the:
FDA is working to determine whether the reprots of cleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.
You can read the entire FDA Safety Review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate) by clicking here.
Pradaxa is being aggressively marketed to doctors and physicans are likely being urged to prescribe Pradaxa instead of Coumadin because, apparently Pradaxa does not require the on-going blood tests/lab monitoring required by Coumadin patients. However, the risks of Coumadin are already well-known and well studied. The risks of Pradaxa seem to be unknown at this time, and the drug has not been on the market for long enough to know the exact level of risk. There is concern from the on-going clinical trials that the risk of bleeding events in older elderly patients may be higher for those taking Pradaxa compared with Coumadin. Despite this, since Pradaxa's approval in October 2010 about 1.1 million Pradaxa prescriptions have been dispensed to about 371,000. patients. It should also be noted that there is an antidote to overcoagulation by Coumadin/Warfarin (vitamin K), yet there is apparently no known well-studied antidote to bleeds caused by Pradaxa.
If you or someone you love has suffered an injury, bleeding event, or death after taking Pradaxa contact Goldberg, Finnegan & Mester, LLC at 888-213-8140.