There is a higher risk of gastrointestinal bleeding with Boehringer Ingelheim’s Pradaxa than with warfarin (Coumadin), a recent study completed by the U.S. Food and Drug Administration (FDA) shows. According to Drug Discovery & Development, the study used information from over 134,000 Medicare patients aged 65 years or older to analyze the risk of ischemic or clot-related stroke, bleeding in the brain, major GI bleeding, myocardial infarction (MI) and death.
The study found that there was an increased risk of major gastrointestinal bleeding with the use of Pradaxa compared to warfarin. The risk of MI, or heart attack, was similar for the two blood thinners. Although there was a lower risk of clot-related stroke, bleeding in the brain and death with Pradaxa, there is no way to stop any bleeding that does occur with this drug. It is important to note that in this study, the patient population was much larger and older than research used in the agency’s earlier review of post-market data. The findings are consistent with the trials used as a basis for the drug’s approval, and the agency has not made any changes to the current label.
Pradaxa and warfarin are both used to reduce risk of blood clots and stroke in patients who have atrial fibrillation (AF), a type of abnormal heart rhythm. Warfarin is a much older drug that has been on the market for decades; users have to undergo blood testing and have certain food restrictions. Pradaxa has been touted as superior to warfarin because it does not require these things, but there have been other safety concerns about this new blood thinner. With Pradaxa, there is no antidote to the reverse the bleeding if it does occur. If bleeding occurs in warfarin users, doctors are able to stop the life-threatening bleed with Vitamin K.
A number of Pradaxa lawsuits have been filed over bleeding-related deaths or injuries. These suits alleged that Boehringer Ingelheim failed to warn about the irreversible bleeding risk associated with Pradaxa.
As of December 31, 2011, the U.S. Food and Drug Administration (FDA) has received more than 500 reports of Pradaxa-related deaths. Additionally, there have 900 reports of gastrointestinal bleeding, 300 reports of rectal bleeding and over 200 reports of cerebrovascular accidents associated with the use of Pradaxa, one lawsuit filed in the U.S. District Court of Philadelphia says.