Pradaxa Fast Track: No Place for Bleeding Hearts

Nashville, TNThere is little doubt the need was there and has been for some time: a blood thinner that required less monitoring and maintenance than warfarin. Pradaxa appeared to deliver on that end. But grievous Pradaxa side effects, including uncontrollable Pradaxa bleeding, have led to many lawsuits and have caused health advocates to wonder if regulators were prudent to approve it so quickly.

That's a question raised by the Journal of the American Medical Association (JAMA), the prestigious publication which, on September 5, targeted the renewed focus of the US Food and Drug Administration (FDA) to further cut the red tape and get new, promising drugs onto the market sooner in an effort to benefit a greater number if patients, and to give the medical community a boost to its basket of tools to treat an aging population.

However, bleeding has proven to be a real problem. Once it starts, it's very difficult if near impossible to stop it, resulting in Pradaxa deaths. Authors of the JAMA article, upon study and reviews of the safety records of Pradaxa and two other drugs, concluded that said safety records "raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered and with optimal doses not determined."

Television station 7 KLTV in Tyler, Texas (9/23/12) referenced a PRWeb news release summarizing the conclusions of the JAMA-published study. USA Today (8/19/12) also weighed in, noting that the FDA logged no fewer than 3,781 adverse reaction reports in 2011. According to USA Today, that figure eclipses the adverse reaction reports associated with all other monitored drugs for that year.

There were 542 Pradaxa deaths in that time. And those are the reported deaths to the FDA.

A plaintiff in a Pradaxa lawsuit, Charles Jackson began to experience intestinal bleeding three weeks after starting on Pradaxa in the aftermath of a stroke. His doctor, according to The Tennessean (8/17/12), told him to get off Pradaxa.

Since Pradaxa was approved by the FDA in an expedited fashion, sales of Pradaxa has been reported to be as high as $1 billion. The Tennessean reports that millions of people across the US take dabigatran Pradaxa twice per day.

One Pradaxa attorney believes that as Pradaxa lawsuits go, this could be one of the largest mass torts in the history of the nation. For Pradaxa patients, there are plenty of reasons to be wary. Earlier this year a study under the auspices of the renowned Cleveland Clinic found that Pradaxa had the potential to increase risk of Pradaxa Heart attack, along with irreversible bleeding.

Roy Heady of Cookeville, Tennessee switched from Coumadin to Pradaxa last spring, only to be hospitalized for a hemorrhage. No longer taking Pradaxa, Heady still suffers from internal bleeding as a result of Pradaxa, according to the Tennessean.

"I thought it would lessen the headache of being on Coumadin," said Heady, 65. "But it ended up creating more of a headache." Heady is a plaintiff in a Pradaxa lawsuit.