Until The Bleeding Stops, Pradaxa Side Effects Remain a Concern

Walnut Creek, CAWith Pradaxa side effects, it's one step forward, two steps back: while doctors were buoyed by the availability of an alternative to Coumadin (warfarin) for thinning of the blood, the potential for Pradaxa patients to perish from uncontrollable bleeding is a sobering reality.

The San Francisco Chronicle (11/28/12) notes that research is ongoing to come up with an effective antidote capable of reversing bleeding once it starts. Currently, the Chronicle notes, there is no antidote available for Pradaxa. Not surprisingly, Pradaxa lawsuits have emerged from Pradaxa deaths when bleeding from an injury or surgery could not be stopped due to the use of Pradaxa.

Drugs such as Pradaxa are employed for stroke patients, or to prevent Pradaxa heart attack. The anticoagulant works to diminish blood's capacity for clotting. This, in turn, is useful in helping to prevent blood clots that could cause a stroke, or heart attack.

Warfarin remains the most widely-prescribed anticoagulant, and remains effective for the vast majority of patients. Aside from the fact warfarin was originally developed as a rat poison, the primary negative issues with the anticoagulant remain its numerous drug and food interactions, coupled with the need for monthly monitoring.

Dabigatran (Pradaxa) has proven to be much more user-friendly, with fewer limitations and less need for regular monitoring.

The problem with Pradaxa—and the foundation for the most grievous of Pradaxa side effects—is the inability to reverse serious bleeding once it starts. Warfarin can be reversed with the use of Vitamin K, the latter serving as a means to reverse the anti-clotting qualities of warfarin, allowing the blood to resume the clotting necessary to stop uncontrolled bleeding.

Many a Pradaxa lawsuit has claimed that a plaintiff who suffered serious bleeding issues—or even Pradaxa death—was not made aware of the inability to reverse massive bleeding.

Dr. Matthew DeVane, a cardiologist who practices in Walnut Creek, noted the advantages of having the new-age anticoagulants such as Pradaxa available, as a secondary option to warfarin.

"The downside of the new ones," he told the Chronicle, "is we don't have an antidote to reverse the blood thinning effects."

The US Food and Drug Administration (FDA) approved Pradaxa only two years ago. In its first full year of availability, according to the Institute for Safe Medication Practices, there were over 500 deaths associated with Pradaxa use in 2011. That data, which is reported to the FDA, has put the FDA in somewhat of a defensive mode, highlighting recent studies that suggest the risk for bleeding associated with Pradaxa is no greater than those patients taking warfarin.

However, there were 72 deaths associated with warfarin in 2011, v. 542 for Pradaxa. It appears likely, therefore, Pradaxa lawsuits will continue until an effective antidote is found for dabigatran Pradaxa—and the bleeding stops.