Still Stuck on Pradaxa | Levin Papantonio - Personal Injury Lawyers

Still Stuck on Pradaxa

Despite the fact that Pradaxa can cause uncontrollable, irreversible bleeding that can lead to fatal consequences, prominent heart specialists are still recommending it to their patients. Some, like Dr. Keith Churchwell, who heads up the Heart and Vascular Institute at Vanderbilt University, are a bit more cautious about it. Others, such as Dr. George Crossley, feel that reports of the dangers of Pradaxa have been exaggerated.

Dr. Churchwell appreciates the fact that Pradaxa is faster-acting. There are far fewer interactions with other drugs (an important issue with elderly patients who may be taking many different prescriptions on a routine basis),  meaning that less monitoring and testing is necessary. It's easy to use and highly effective. However, Churchwell acknowledges the danger of “significant bleeding,” pointing out that at present, doctors “don't have a good mechanism to reverse it” (other than emergency dialysis – an uncertain process).

Dr. Crossley, head of Baptist Hospital's cardiology program, is a staunch defender of the drug. He and his staff were among the first medical professionals to prescribe Pradaxa after it was approved by the U.S. Food and Drug Administration. He cites a study that was published in the New England Journal of Medicine in September of 2009, over a year prior to the FDA's approval. The study concluded that at lower dosages “...rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage.” At higher dosages (150 mg), rates of hemorrhage were the same for both medications, however.

Dr. Crossley does not refer to the fact that once a patient on Pradaxa starts to bleed, there is no effective way of stopping it. He was quoted in the Nashville Tennessean however as stating that the  “...data we have is very, very strong. For both safety and efficacy, Pradaxa is preferred.”

It should be mentioned that the NEJM study to which Dr. Crossley refers was based on what was known as the RE-LY Trial – one that was funded by the drugmaker, and was later called into question. (The head researcher in that study also had financial ties to Boehringer-Ingelheim.)

Both Dr. Churchwell  and Dr. Crossley are well respected in their fields and have both received excellent reviews from patients who would not hesitate to recommend their services to others. It light of the latter's staunch defense of Pradaxa however, it is worth noting that when Dr. Crossley was a presenter at  medical conference in Boston this past May, he disclosed that he had received a research grant from Boehringer-Ingelheim.

Sources

Allen, Bobby. “Nashville Doctors React to Pradaxa Reports.” The Tennessean, 22 August 2012.

Connoly, Stuart J. MD, et. al. “Dabigatran versus Warfarin in Patients with Atrial Fibrillation.” New England Journal of Medicine, vol. 361 no. 12 (17 September 2009.)

N/A.  “Presentation Abstract: All ICDs Should be Single Chamber or CRT Devices (AMR).”  Heart Rhythm Society for their 33rd Annual Scientific Sessions, 2012. Document available at  here All ICDs Should be Single Chamber

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