Pradaxa Gastrointestinal Bleeding Problems for Elderly with Kidney Impairment

Austin Kirk

By Austin Kirk
Posted April 16, 2012


A recent medical case report published in the Annals of Pharmacotherapy highlights the risk of gastrointestinal bleeding from Pradaxa among elderly patients with kidney impairment, and underlines the impact of the manufacturer’s failure to provide accurate information for medical providers about the need to appropriately select patients to receive this newer drug and monitor renal function among older users.

Our lawyers were previously investigating potential claims for individuals throughout the United States who may be entitled to financial compensation through a Pradaxa lawsuit for gastrointestinal bleeding and other complications caused by this newer anticoagulant.

In the April 10, 2012 issue of the Annals of Pharmacotherapy, a medical case report is presented involving a 66 year-old woman who suffered from acute renal failure and gastrointestinal bleeding after being given Pradaxa for atrial fibrillation. She took Pradaxa 150mg dose twice a day for two months, until she experienced severe gastrointestinal bleeding that resulted in a 47-day hospital stay. Following her hospitalization, she was transfer to a nursing home where she died two months later.

During the six months before she started using Pradaxa, the patient had intermittent renal insufficiency or kidney impairment. Since Pradaxa is eliminated through the kidneys, this may result in a build up of the drug within the system, further increasing the risk of serious and potentially life-threatening bleeding from Pradaxa.

As the case study abstract discusses:

Renally eliminated drugs such as dabigatran (Pradaxa) place elderly patients at increased risk of drug accumulation and adverse drug events due to age-related decline in renal function. In a recent case series dabigatran (Pradaxa) toxicity in the elderly with renal impairment was described with 1 fatal outcome. Recent literature, including package insert, advises intermittent monitoring of renal function in the elderly and those with moderate renal impairment. Consideration should also include the appropriateness of dabigatran (Pradaxa) therapy in patients with fluctuating renal function.

This report and hundreds of similar cases experienced by individuals throughout the United States highlight the critical importance that accurate information be provided by the manufacturer, Boehringer Ingelheim, about the risks associated with using Pradaxa for individuals with impaired kidney function, especially elderly patients who may experience intermittent renal problems. Unfortunately, prior to the January 2012 Pradaxa warning update, the medical community was not provided with indication that they should assess renal function before starting Pradaxa and periodically assess and adjust therapy as needed.

Boehringer Ingelheim aggressively marketed their new anticoagulation therapy as a superior alternative to warfarin (Coumadin), causing many patients to switch from the older, cheaper and just as effective medication for reduction of strokes associated with atrial fibrillation. While marketing this one-size-fits-all anticoagulant, they failed to provide information about the importance of patient selection in the decision to prescribe the medication.


In addition to failing to adequately warn about the risks of using Pradaxa among elderly patients with kidney problems, the drug maker also failed to adequately warn consumers and the medical community about the lack of a reversal agent to stop any gastrointestinal bleeding that may develop while using the medication.

The Pradaxa lawyers at Saiontz & Kirk, P.A. are no longer reviewing potential cases for individuals throughout the United States. All lawsuits were reviewed on a contingency fee basis, which means that there were no fees or expenses unless a recovery is obtained.


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