Friday, June 8, 2012

A Review of Pradaxa: Part One - Warfarin vs. Pradaxa: Benefits vs. Risks

What is Atrial Fibrillation?

Approved by the FDA in October 2010, Pradaxa is the first anticoagulant drug to be marketed in over half a century. Warfarin was approved for use in 1957 and despite its limitations has been used ever since. Both drugs are used in the treatment of atrial fibrillation which can lead to stroke. Atrial fibrillation occurs when the upper chambers of the heart begin beating irregularly—while often there are no overt symptoms of atrial fibrillation some people may have palpitations, fainting episodes or chest pain.

Atrial fibrillation increases the risk of stroke as much as seven times that of people without the disease and can be higher depending on other risk factors such as high blood pressure. Atrial fibrillation is typically treated with oral medications which get the heart rhythm back to normal although surgical therapies are used in some instances. Most of those with atrial fibrillation will be put on an anticoagulant medication such as Warfarin or Pradaxa to decrease the risk of stroke. A full third of all strokes are caused by atrial fibrillation, therefore it is a very serious disease.

Limitations of Warfarin

Although doctors consider Warfarin the mainstay drug in the treatment of atrial fibrillation it nonetheless has a wide variety of limitations. There are four major clotting factors in the body, and Warfarin works by preventing the activation of those factors which are dependent upon Vitamin K. Because of the way it works, should there be a severe bleeding event as a result of Warfarin the patient can be given a dose of Vitamin K to effectively reverse the anticoagulant effects and stop the bleeding. While Warfarin is well known to reduce the risk of blood clots caused by atrial fibrillation, it can also be responsible for causing excessive bleeding, particularly in the brain.

Additionally, Warfarin has been found to have a wide range of negative interactions not only with other prescription drugs but also with certain foods and even herbal supplements. Grapefruit or grapefruit juice cannot be ingested while taking Warfarin as they can change the way the body metabolizes the drug. Further, foods such as avocados, margarine and mayonnaise should be eaten in small amounts as well as dried basil, thyme and oregano. Those taking Warfarin are also cautioned against drinking alcohol or taking supplements of Vitamins A, E or C. Many herbal supplements have been found to react badly with Warfarin as well, so patients taking Warfarin must be extremely vigilant in monitoring their health. Those taking Warfarin must undergo blood tests as often as once every two to four weeks to monitor the anticoagulation levels in the body. Patient compliance is often as serious issue among those taking Warfarin, a factor the manufacturer of Pradaxa used in their favor.

Benefits and Risks of Pradaxa

After fifty-seven years of using Warfarin as an anticoagulant the medical community was extremely pleased when Pradaxa came on the scene as it appeared at first glance that it had fewer drug and food interactions and worked better in the prevention of strokes due to atrial fibrillation. Pradaxa works as a direct thrombin inhibitor and does not require the frequent INR blood testing. Major studies showed that while Pradaxa was effective in stroke prevention it could also lead to uncontrollable bleeds, particularly in the GI tract, and more commonly in the elderly. Further, the only reversal agent known for Pradaxa-related bleeding is emergency dialysis, and even this is not guaranteed to work.

Therefore the biggest downside to Pradaxa is the inability to stop excessive bleeding while the biggest downside to Warfarin is patient compliance. While Pradaxa is slightly more effective in controlling stroke resulting from atrial fibrillation it should not be used in those with any type of kidney disease or GI troubles. Those over the age of 75 are at a much higher risk of developing kidney disease and GI bleeds and should be thoroughly screened before taking Pradaxa. It has been well-documented that patients who experience any type of GI trouble while taking Pradaxa can be at a three to four times increased risk of developing a gastrointestinal bleed which can be life-threatening or even fatal. Despite this extremely high risk, the patient information which comes with a Pradaxa prescription fails to mention the fact that should any GI issues arise the patient should immediately contact their physician.

It is also believed that Pradaxa may bring an increased heart attack risks in addition to the risks associated with gastrointestinal bleeds. Pradaxa’s risk of serious heart attack is believed to be as much as 33% more than that of patients taking Warfarin although Boehringer claims only the slightest risk in heart attacks for Pradaxa patients. Another potential risk of Pradaxa lies in the fact that a single missed dose of Warfarin has no significant effect on the efficacy while a single missed does of Pradaxa can dramatically lessen the anti-coagulant effect, putting the patient at an extremely high risk of pulmonary embolism. Since most of us have missed a dose of a prescription drug at one time or another in our lives, this can be considered a fairly serious issue in those taking Pradaxa particularly because of the twice-a-day dosage schedule.

Many elderly patients have reported a specific adverse effect of Pradaxa; they fell and bumpted their heads then were later rushed to the hospital where they were found to have severe intracranial bleeding. A New Zealand study noted a significant amount of bleeding episodes among those taking Pradaxa, and the majority of those were in patients over the age of 75. These hematologists believed prescriber error was responsible for at least a quarter of those bleeding complications in that many physicians are not fully aware of the potentially serious side effects associated with Pradaxa and those that are fail to properly warn their patients of those risks. Both Warfarin and Pradaxa have pros and cons and it’s important that the patient taking either of these drugs become fully informed regarding the potential side effects.

Author: Sullo & Sullo Attorneys

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