Pradaxa and Xarelto are promoted for their effectiveness, safety, and ease of use for both the physician and the patient, but these new oral anticoagulants have one drawback in common: There is currently no available antidote to reverse excessive bleeding that can be caused by the drugs. This lack of an antidote is the main difference between these drugs and the anti-coagulant warfarin, from which excessive bleeding can be reversed with a vitamin K injection.
This lack of antidote was the focus of leading clinicians and researchers who attended a “think tank” session hosted by the U.S. Food and Drug Administration and the Cardiac Safety Research Consortium in Maryland to discuss the future of these drugs. The goal of the session was to find a way to obtain approval for antidotes for Pradaxa, manufactured by Boehringer Ingelheim, and Xarelto, manufactured by Johnson & Johnson, as well as several other similar medications.
No Antidote for Pradaxa
According to a cardiologist from Lankenau Heart Institute, six million people are on outpatient anticoagulants in the U.S., and last year, one in 30, or 200,000 patients, were admitted to the hospital for complications with bleeding, including 65,000 patients taking new oral anticoagulants. One doctor attending the session stated that while an antidote was not necessary in order to effectively and safely use these drugs, a reversal agent would improve the uptake of the medications.
Plaintiffs Claim They Were Unaware of a Lack of Antidote
Thousands of Pradaxa lawsuits pending in courts across the U.S. allege that patients suffered from serious problems as a result of Pradaxa use. Bellwether trials have recently been scheduled, and the first is scheduled to begin in September 2014. While Pradaxa was reportedly marketed as being safer and more effective than other comparable medications, it also allegedly came with life-threatening side effects.
One of the most common claims of problems with Pradaxa is that of a lack of an antidote. According to several plaintiffs filing lawsuits alleging problems with Pradaxa, the manufacturer failed to warn patients that they may experience serious bleeding complications and neglected to inform them that there is no known reversal agent should a bleeding episode occur.
Have You Experienced Problems with Pradaxa?
If you or someone you love has suffered from problems with Pradaxa and would like to learn more about pursuing a claim for compensation, Attorney Group provides free case evaluations to patients to determine whether they have a case. We can answer your questions and connect you with an affiliated attorney who can assist you in filing a lawsuit and seeking the compensation to which you may be entitled.