Boehringer Ingelheim, maker of the increasingly popular anticoagulant drug Pradaxa, has announced that it will establish a new patient registry which will allow the company to track the safety of Pradaxa for patients suffering from a heart rhythm condition known as atrial fibrillation (AF).
The GLORIA(TM)-AF Registry is expected to be completed in 2020 and Boehringer’s goal is to enroll approximately 56,000 patients in the tracking program. The GLORIA-AF Registry will track newly-diagnosed Non-Valvular AF patients in 50 countries around the world. Boehringer’s goal in creating the program is to gather real-world data on patient demographics, disease characteristics, treatment decisions as well as evaluate the safety and efficiency of various antithrombotic treatments. In addition to Pradaxa, these treatments may include warfarin, another blood-thinning agent, acetylsalicylic acid and Xarelto (rivaroxaban).
Pradaxa (dabigatran) was first approved by the U.S. Food and Drug Administration in 2010 as an alternative to warfarin, which has long been associated for use with patients suffering from AF. Atrial fibrillation is a condition that occurs when the heart beats irregularly, potentially causing blood clots to form in the lungs. These clots can potentially lead to stroke or heart attack if not treated. Pradaxa has been touted as a safer alternative to warfarin, with Boehringer making the claim that the drug will prevent as many as 5,000 strokes per year in AF patients.
Since Pradaxa first came on the market, numerous concerns have been raised over the drug’s safety. While Boehringer maintains that the drug is safe, the company has also acknowledged that Pradaxa has been linked to as many as 260 deaths worldwide. A recent article from QuarterWatch, an independent publication that monitors FDA adverse events reporting, suggests that there may be more Pradaxa deaths than previously thought. The deaths have widely been linked to serious bleeding events and it’s also believed that Pradaxa may increase the risk of heart attack.
Several studies have supported a possible link between Pradaxa and serious bleeding events, including a March 2012 case study conducted by a group of Utah researchers. That study involved an elderly man who died of a severe brain hemorrhage after suffering a minor fall. The researchers suggested that Pradaxa users may be at risk for severe complications after experiencing a minor head injury. However, a sub-analysis published last month in the Journal of the American Heart Association indicated that Pradaxa is associated with a lower risk of intracranial hemorrhage compared to warfarin, making it clear that more research is needed.
In the U.S., Boehringer currently faces a handful of lawsuits filed in connection with Pradaxa bleeding deaths. The lawsuits allege that the company was aware of the potential risk but did not adequately warn consumers of the dangers. Individuals who suffered complications after using Pradaxa are encouraged to contact an experienced Pradaxa injury attorney to discuss their legal rights.
NadrichCohenLLP