A case report published in the Journal of Clinical Toxicology in April of 2012 calls into question, once again, the safety of Pradaxa (also known dabigatran.) This case report was written by Dr. Leah Kernan of the Fort Hood, Texas Army Medical Center Emergency Medicine Department, and Dr. Farshad Shirazi and Keith Bosen, Pharm.D., both from University of Arizona College of Pharmacy, Arizona Poison and Drug Information Center located in Tucson, Arizona.
The authors reported that a 92-year old patient died after taking Pradaxa for only one day. This particular patient was diagnosed with atrial fibrillation, and Pradaxa was the first medication prescribed to this patient shortly after the diagnosis. The patient was prescribed 150 mg twice daily and took his first dose of Pradaxa before bedtime. This Pradaxa patient reportedly awoke the next morning with profuse rectal bleeding and was transported to the ER, where he was resuscitated with IV fluids, packed red blood cells, vitamin K, and antibiotics. A thorough medical evaluation, including emergency endoscopic examination, identified a bleeding gastric ulcer as the source of the patient’s profound bleeding, which was difficult to stem due to the lack of a reversal agent for Pradaxa. Despite quick identification of the source of the Pradaxa-induced gastric bleeding and aggressive medical care, the patient required intubation, additional units of blood, and ultimately died six days after his admission to the hospital.
The authors made several recommendations to other practitioners who might be faced with the challenges of saving the life of a patient who has suffered a Pradaxa-induced bleed, including use of dialysis, vasopressive agents, blood products, bleeding site repair, and perhaps administration of recombinant activated factor VIIa or activated prothrombin complex concentrate. This case report is also noteworthy as it provides unbiased information about the difficulties in stabilizing a patient with a Pradaxa-induced bleed, as well as the tragedy that befell this particular patient after taking the drug only once. The authors speculated that the patient may have developed toxic levels of Pradaxa in his system so quickly due to a possible drug interaction and/or underlying renal insufficiency. The authors concluded: “In older patients who have renal insufficiency, there is a potential for gastrointestinal bleed; the advantage over warfarin does not outweigh the risk of fatal bleeding and coadministration should be avoided with p-glycoprotein inhibitors.”
Drug safety advocates have been lobbying for the removal of Pradaxa from the market since late 2011 when physicians first started sounding the alarm about catastrophic or fatal bleeding injuries associated with the atrial fibrillation drug, which has been on the market in the United States for less than two years.
Lawsuits filed by Searcy Denney and others focus on several defects in the design of Pradaxa and the warnings which are given to prescribing physicians and patients, which are prominent in the case report written by the Fort Hood medical team. Below is an excerpt of the allegations included by our law firm in an individual lawsuit filed against Boehringer Ingelheim and related entities on behalf of a plaintiff who suffered a near-fatal GI bleed after taking Pradaxa for just a few days:
Pradaxa was unreasonably dangerous to an extent beyond that which could reasonably be contemplated by patients or their prescribing physicians;
Any benefit of Pradaxa over Coumadin (warfarin) and other therapies for non-valvular atrial fibrillation was outweighed by the serious and undisclosed risks that patients face when they ingest Pradaxa as prescribed and in the manner intended by Pradaxa’s manufacturers;
The dosages and/or formulation of Pradaxa sold by the Boehringer Ingelheim was unreasonably dangerous;
There are no patients for whom the benefits of Pradaxa outweigh the risks of ingesting the drug;
Pradaxa was not made in accordance with the Defendants’ own specifications or performance standards;
There are no patients for whom Pradaxa is a safer and more efficacious drug than other drug products in its class that are prescribed for the treatment of atrial fibrillation; and
There are safer alternatives to Pradaxa that do not carry the same risks and dangers as those that have been associated with use of Pradaxa.