As Lawsuits Mount, Pradaxa Manufacturer Tests Antidote

At the annual meeting for the American Heart Association in Dallas on Monday, scientists announced that an antidote for the anticoagulant Pradaxa is in the making. In light of mounting lawsuits against the drug’s manufacturer Boehringer Ingelheim, the antidote is much-needed.

The experimental antidote comes after nearly 1,600 lawsuits have been filed.

The first phase of a clinical study with 145 healthy males found that the experimental antidote supplied immediate, complete, and sustained reversal of the anticoagulant effect achieved by Pradaxa, according to the manufacturer’s website. The blood-clotting effect lasted for 12 hours after treatment and showed no side effects.

In the study, the antibody was administered in two steps; first, it was injected intravenously in rising doses to test tolerability, and second, it was introduced in three different doses following usage of Pradaxa twice a day for three days.

The antidote has not been approved for clinical use yet, but Boehringer Ingelheim plans to continue studies with the antidote in 2014.

The experimental antidote comes after nearly 1,600 lawsuits have been filed in federal court against Boehringer Ingelheim. Plaintiffs accuse the company of failing to provide an adequate warning on the drug’s label and failing to provide an antidote for Pradaxa. When Pradaxa was first approved by the U.S. Food and Drug Administration in 2010, it was believed to be superior to the anticoagulant warfarin because it had fewer restrictions and required less monitoring, Reuters reported.

Without an antidote, though, Pradaxa’s anti-clotting effects could cause serious and life-threatening consequences in patients should accidental bleeding occur. Patients who have filed lawsuits against Boehringer Ingelheim claim they experienced severe and uncontrollable bleeding in their gastrointestinal tract, brain, or kidneys after taking Pradaxa. In 2012, more than 580 deaths on behalf of patients who took the drug were reported to the FDA Adverse Event Reporting System.