Thursday, June 14, 2012

Pradaxa Litigation: Pradaxa vs. Warfarin



A group of attorneys interested in the Pradaxa litigation assembled to discuss the issue in a recent seminar. Pradaxa is a drug prescribed primarily for atrial fibrillation, which is essentially an irregular heartbeat. While the heart generally contracts and relaxes to a regular beat, in the case of atrial fibrillation, the upper chambers of the heart don’t beat as they should, depriving the body of oxygen. While people can live with atrial fibrillation, it can lead to chronic fatigue, heart failure or most serious of all, strokes. While Warfarin has been the drug of choice for over a half century in the treatment of atrial fibrillation, Pradaxa was believed at the time of its release to perform better with fewer side effects. 

The first attorney speaker at the seminar noted that Pradaxa has just been named on the FDA’s list of the 16 drugs to watch in April of 2012. While the appearance of a drug on the “watch list” does not mean the FDA has concluded it actually poses a health risk, only that they will continue to study these watched drugs to determine whether there is a causal link. Should the causal link be established, a regulatory response would be likely which could include a revision of the label on the drug or the requirement of a risk evaluation study. The FDA cautions that they are not advocating for doctors to cease issuing prescriptions of these drugs or stating that patients should stop taking them, however more research is necessary.

The Company Who Manufactures Pradaxa

Boehringer Ingelheim was founded in 1885 in Ingelheim, Germany, beginning with only 28 employees who manufactured tartaric acid salts. They are now a global enterprise, employing over 40,000 people in fifty different countries. In 2009 Boehringer boasted net sales of over $17 billion dollars, and currently operates five subsidiaries in the United States with the largest based in Ridgefield Connecticut.

The Downside of Warfarin

Although Warfarin—also known as Coumadin—has been on the market since 1954, and overall has been found to work reasonably well, it does have drawbacks. Warfarin is well-known for producing adverse reactions to other drugs and different foods—a varied diet can lead to variable anticoagulation effects meaning its effects can be unpredictable. Patients who take Warfarin must have their blood drawn every two weeks, therefore the biggest drawback of Warfarin lies in patient compliance as far as eating habits, what other drugs they are taking and whether they will consistently have their blood monitored for adverse effects. Dosage modifications are often necessary in patients taking Warfarin which, once more, demands high patient compliance.

What is Pradaxa and Who is a Good Candidate?

Pradaxa or Dabigatran, was originally discovered in the 1980’s although it was not approved for patient use until much later. The European Commission granted marketing approval for Pradaxa in March, 2008, allowing sales in 27 European countries. Based on a Phase II RE-LY study of Pradaxa, the drug received FDA approval in October of 2010, however scarcely a year later the FDA provided a safety report for Pradaxa after receiving reports of excessive bleeding among Pradaxa patients.  The patient who is not an appropriate candidate for Pradaxa would be one who has consistently positive reports from being on Warfarin, a person with known renal dysfunction or one with a history of GI disease or bleeding. Those with a history of coronary artery disease of myocardial infarction are also not good candidates for Pradaxa.

Good Candidates for Pradaxa

Those patients who have unstable INR’s from Warfarin use—blood work results— or those who have not been particularly compliant with their INR monitoring might be good candidates for Pradaxa. A good renal function is crucial before beginning Pradaxa as well as a history of positive medicine compliance. Finally, there must be no known medication interactions with Pradaxa before starting the prescription drug.

Construction of the Pradaxa Capsules and How it Causes Problems

There are hundreds of Dabigatran pellets within the capsule itself however each pellet is constructed of a tartaric acid core. This makes Pradaxa unique in how it gets into the patient’s system. The active ingredient in Pradaxa is contained in the outer shell of each pellet with the encapsulated portion containing the tartaric acid. Many scientists believe this method of delivery means the drug is much more rapidly absorbed due to the acidity of the digestive tract. The theory is that this delivery system can lead to major GI bleeds causing a fairly minor ulceration to become a serious or fatal bleed out. 

The construction of the Pradaxa capsule has been likened to an M & M—the inside tartaric acid is very low ph and is not particularly soluble. Most especially in the elderly, this delivery system can create a very acidic environment. Patients who may already have unknown small bleeds in the GI tract are as much as four times as likely to develop serious GI bleeds. Those with kidney problems are equally unable to eliminate the drug from their system, and it can build up to dangerous levels.

The Crucial Difference Between Pradaxa and Warfarin

Should Warfarin lead to excessive bleeding, those ill-effects can be safely reversed with the administration of a dose of Vitamin K. Unfortunately, there is no known antidote to the effects of Pradaxa which leaves patients vulnerable to bleeding out. Pradaxa is a direct thrombin inhibitor which has shown promise in reducing the number of strokes and allowing those with atrial fibrillation to lead a healthier life, however ER doctors across the United States agree they universally get a feeling of dread when a patient comes into their ER who is taking Pradaxa. In short, there is no effective antidote for major gastrointestinal bleeds among those taking Pradaxa and in the case of trauma bleeds, the results can be fatal. The drug is active in the gastrointestinal tract on contact, and the renal clearance time is slow, particularly in those with a history of renal impairment. The second part of this Pradaxa litigation article will talk about the RE-LY study as well as the clinical trials performed by Boehringer Ingelheim.
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