The Bleeding Truth of Pradaxa

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On March 18, 2008 the world was introduced to the novel anticoagulant dabigatran (compound BIBR 953), more commonly known as Pradaxa®. Originally developed in the 1980s, Pradaxa is a direct thrombin inhibitor. It’s a novel anticoagulant heavily marketed as the anticoagulant of the future because unlike its predecessor, Warfarin, it needs not be monitored with daily and or weekly blood tests; or so positions Boehringer Ingelheim.

Since the 1950s, the tried-and-true and standard anticoagulant of choice has been Warfarin. Originally used in 1948 as rodenticide; Warfarin was approved for human medical use in 1954 as it was found to be an effective therapeutic anticoagulant, preventing both thromboembolism and thrombosis. Due to its potential lethality however, the drug has to be carefully monitored with blood analysis of the international normalized ration (INR) to ensure that patients are therapeutic. Daily titration of the medication initially is crucial in achieving a safe level of anticoagulation, while avoiding hemorrhage.

Now almost half a century after Warfarin came onto the market, Pradaxa has been heavily marketed because it requires no maintenance and is reported to have fewer side effects. Patients now commonly request that their anticoagulation be changed to the newer sexier alternative. Clinging on the fact that no further daily or weekly blood draws are necessary with the novel drug. Largely due to Boehringer Ingelheim’s effective marketing of the drugs; patients often see this as a great benefit. Unfortunately, this perceived benefit comers with a great cost. Unlike Warfarin, Pradaxa has no reliable laboratory test to monitor its level of anticoagulation. Worse yet, unlike its counterpart, there are not effective antidote or reversal agents in the event of hemorrhage. One does not monitor the efficacy of Pradaxa because there are no effective tests and even if one was developed, once a patient is identified as supratherapeutic, the impending hemorrhage is irreversible.

In only two years after its release into the market, of the patient’s prescribed Pradaxa for anticoagulation, 3,781 had adverse events reported to the FDA. Of the reports 2,367 were because of hemorrhage, 644 were because of stroke, 291 were due to the development of kidney failure, and most striking 542 were reported deaths. That same year, the FDA reported a total of 1,105 adverse events from patients prescribed Warfarin.

As a general surgeon my concern with Pradaxa and other novel anticoagulants is the lack of a reliable laboratory test for safety monitoring. Most importantly however, what ails me the most is the inability to effectively reverse the agent. Like it or not, as we age our ability to manage our gait, our ability to minimize clumsiness, and our ability to prevent bodily injury decreases substantially. I fear greatly for each and every patient who are placed by their primary care provider on Pradaxa. I personally feel that the risks of this medication outweighs the inconvenience of having your finger pricked every day or even every week to insure a therapeutic dose of warfarin.

Importantly, not only is Warfarin safer, easily monitored, and reversible its one of the cheapest medication one can buy… even if under or uninsured. An average under or uninsured person spends $200 on Warfarin yearly. An average under or uninsured person spends $3,000 on Pradaxa yearly. Not only is Pradaxa a much riskier alternative, its also fifteen times more costly. Unfortunately the marketing of Pradaxa has been so effective that despite the increased risk and cost patients still consistently ask to be switched over to it.

Perhaps in the future we shall have a safe means of monitoring and even reversing the anticoagulation effects of Pradaxa. In the meantime, I shall continue to be cautious and continue to discourage its use. I recommend to all my patients to carefully weigh out the risk and benefits. When something sounds too good to be true, it often is.

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