The Jury is Still Out on Pradaxa Benefits and Risks

Nashville, TNThe jury is still out, both literally and figuratively, regarding Pradaxa side effects. The blood thinner, a recent-generation drug that was thought to be an improvement over Coumadin for the prevention of blood clots leading to heart attack and stroke, has been bolstered by studies that suggest it is just as effective as the 50-year-old blood thinner, with greater benefits and fewer restrictions.

But plaintiffs having launched Pradaxa lawsuits beg to differ. Aside from Pradaxa heart attack, which has been linked to the new-age thinner, is concern over the potential for Pradaxa bleeding. While plaintiffs admit the potential for bleeding was included in the list for Pradaxa side effects, they claim to have not known or been told that in some cases the bleeding is irreversible.

Bleeding that can't be stopped is a threat to the very life of the patient.

The medical community has been eager to find a more modern alternative to Coumadin, which carries dietary restrictions and is slow to act in some patients. The arrival of Pradaxa—which presents as faster acting and requires fewer restrictions—was initially embraced.

However, according to The Tennessean (8/22/12), that initial embrace has descended into debate over the true merits of Pradaxa v. the risks.

Dr. George Crossley, who heads the cardiology program at Baptist Hospital in Nashville, is an advocate of dabigatran Pradaxa and cites the drug's benefits. The Tennessean notes that Crossley's team of heart specialists were among the first to test Pradaxa before it arrived on the market, and they concluded Pradaxa was an improvement over what has been commonly prescribed for a half-century.

The doctor also cited a study published in the New England Journal of Medicine (NEJM) that found Pradaxa to be equally effective with Coumadin. "The data we have is very, very strong," he said in comments published in the Tennessean. "For both safety and efficacy, Pradaxa is preferred."

However, not everyone in the medical community shares that view.

While Dr. Keith Churchwell, executive director of Vanderbilt's Heart and Vascular Institute, concurs with the therapeutic benefits, and the need for fewer exams and dietary restrictions involving Pradaxa, he remains concerned about the potential for Pradaxa bleeding—and the risk that comes with not being able to stop it.

"The big reason there's been a slow response to putting more patients on Pradaxa is because of the significant bleeding," he said in published comments. "Right now, we don't have a good mechanism to reverse it." He does admit that, however, that "It's too early to tell if Pradaxa is really something we should be worried about."

Meanwhile, there have been numerous reports of Pradaxa deaths—some of which surround the problem associated with inability to stop bleeding once it starts, putting the patient into certain peril.

As for Pradaxa lawsuits, hundreds of cases were consolidated in federal court in Southern Illinois August 8 as Dabigatran Etexilate Products Liability Litigation MDL # 2385. Pradaxa first arrived to the market in October 2010, and has since become an excellent performer for its manufacturer. Last year, according to The Tennessean, sales reached the $1 billion plateau.