The results of a recent study indicate that those who use Pradaxa (dabigatran) may face greater risks of internal bleeding than those who used Warfarin (coumadin).

Pradaxa is a common blood thinner that is also known as an anticoagulant.  It is one of what many people refer to as the ‘new generation’ of blood thinners because of how it works.

Warfarin was for years the predominant blood thinning medication used by people like those with atrial fibrillation who needed to make sure that their blood didn’t clot, but it has since been overtaken by newer medications that include Pradaxa because of easier management while taking the drug.  The results of this Pradaxa safety study could only heighten concern about the use of this medication.

Study Finds Greater Pradaxa Bleeding Risk

The Pradaxa bleeding study was done in collaboration between medical researchers in the United States and in Spain.  It was recently published in JAMA Internal Medicine.  The study reviewed medical records for more than 9,400 people who had taken an anticoagulant between 2010 and 2011.  8,100 of these people were using warfarin and the other 1,300 were using Pradaxa (dabigatran).

The researchers found the following as they tracked those patients:

• 9 percent of those taking Pradaxa suffered major internal bleeding
• 33 percent of those taking Pradaxa suffered internal bleeding of any severity
• 17 percent of people taking Pradaxa suffered stomach or intestinal bleeding
• 6 percent of people taking Pradaxa suffered bleeding on or near the brain

These percentages compared to those taking Warfarin as follows:

• 6 percent of patients suffered major internal bleeding
• 27 percent of patients suffered internal bleeding of any severity
• 10 percent of patients suffered stomach or intestinal bleeding
• 8 percent of patients suffered bleeding on or near the brain

What this means in terms of results is that people taking Pradaxa(dabigatran) have a 50 percent higher risk of suffering from major internal bleeding than those using Warfarin (coumadin).  They also faced an 85 percent higher risk of enduring some sort of gastrointestinal bleeding.

Pradaxa Bleeding Concerns

Pradaxa was brought to the market with great fanfare, with its manufacturer touting it as being safer than traditional blood thinners like Warfarin (coumadin). Used primarily by people who suffer from atrial fibrillation, or an irregular heartbeat, Pradaxa is supposed to minimize the risk of suffering from a stroke and other serious problems.

One of the major concerns regarding Pradaxa safety is that if an internal bleed is discovered, there is no known reversal agent as there is for Warfarin.  Since there is no Pradaxa antidote for internal bleeding at this time, the risk of Pradaxa bleeding events are potentially far more deadly.

The results of this study only add to the internal bleeding concerns faced by people who use Pradaxa or other related medications such as Xarelto or Eliquis.

Pradaxa Lawsuits

Pradaxa has caused over 250 deaths worldwide and more and more people are reporting serious internal bleeding after using the new generation anti-coagulant. Many of these people are elderly, suffer from kidney problems, or have impaired renal function. Unfortunately, anyone who uses Pradaxa could suffer from serious and/or fatal internal bleeding.

Since it approved Pradaxa in 2010, the FDA has received numerous reports of Pradaxa complications in patients who were receiving treatment with Pradaxa. These incidents have resulted in a closer FDA examination of Pradaxa as well as the filing of numerous Pradaxa bleeding lawsuits by those who have been injured as a result of taking the anti-clotting drug.

Boehringer Ingelheim Pharmaceuticals, the manufacturer of the medication, has already settled one massive Pradaxa class action lawsuit brought against it for these problems for $650 million.