Friday, March 30, 2012

The Dangers of Pradaxa (Dabigatran) Part 3 of 3: Serious Vascular Risks

Pradaxa, the drug which less than a couple of years ago seemed like a dream come true for the hundreds of thousands of patients who were taking Warfarin or Coumadin has had its initial glow tarnished by the ever-increasing number of reports of serious side effects from use of the drug. Although Warfarin has been used as a stroke inhibitor and for those suffering from atrial fibrillation since the 1950’s, it comes with certain restrictions and its own set of side effects. Those who are on a Warfarin regimen must have regular blood tests taken, and must also be very careful of foods and other prescription drugs they mix with Warfarin.

However, there is a significant difference in the way Warfarin and Pradaxa work in the body, most notably the fact that in the event Warfarin causes excessive bleeding, the effects can be reversed by administering a dose of Vitamin K. When Pradaxa causes excessive bleeding there is no known antidote, leaving the patient vulnerable to literally bleeding to death. Pradaxa is a direct thrombin inhibitor which, in the initial 18,000 person trial, showed great promise in reducing strokes and helping those patients with atrial fibrillation lead a healthier life. The manufacturer of the drug, Boehringer Ingelheim, has been accused of rushing through the initial trial in order to get their drug on the market before other potential rivals, ignoring some potential risks in the process.

How Does Pradaxa Work?

The simplest explanation as to how Pradaxa works is that it thins the blood in those with atrial fibrillation, lowering their chances of having a life-threatening stroke. When a person’s heart beats irregularly, the blood is not pumped through the body as effectively as it should be which in turn causes blood to pool in the upper chambers of the heart. This pooling of blood then causes clots to form in the heart which can break away and travel to the brain, blocking an artery and causing a stroke.

Pradaxa’s active ingredient works by attaching itself to thrombin which are the blood’s central clotting agencies, reducing the ability of the thrombin to cause a clot and forestalling a possible stroke. Pradaxa was considered a good alternative to those patients with atrial fibrillation who were already on Warfarin yet were having trouble managing the necessary monitoring regimen, or patients who were on no regimen at all but were considered at risk for stroke. Pradaxa was not recommended for those with mechanical heart valves, those with severe valvular disease those on long-term treatment for deep vein thrombosis or patients with renal impairment. Patients who indicated chronic use of NSAIDS or those who were pregnant were also warned not to take Pradaxa, however patients were warned against discontinuing Pradaxa due to the elevated risk of stroke.

Perhaps even more alarming is the fact that one missed does of Warfarin does not significantly affect the efficacy of the drug. One missed dose of Pradaxa, however, significantly decreases the anticoagulant effect, putting the patient at serious risk of stroke, pulmonary embolism and the formation of thrombus. For every person who regularly takes prescription drugs—and who has accidentally missed a dose for a variety of reasons—this fact is a bit frightening particularly remembering the often-prescribed twice-daily dosing regimen.

Serious Vascular Risks Associated With Pradaxa

Less than a year after Pradaxa received FDA approval, reports of adverse effects of the drug started coming in. Of the 260 reported deaths related to Pradaxa, most occurred in older patients and came about through excessive internal bleeding which doctors were unable to reverse or control. Vascular disorders include internal bleeding, pericardial bleeding, intra-articular bleeding, subdural bleeding and in some cases, death. Intracranial bleeding from Pradaxa has also been noted in some patients, especially following a fall resulting in a bump on the head.

Over a period of two months, a group of New Zealand hematologists noted a “cluster” of bleeding episodes—78 to be exact—among patients taking Pradaxa. Over a dozen of these episodes were considered major and severe, while one person died from excessive bleeding. It was noted that a large portion of the bleeding incidents involved patients over the age of 75, or those with impaired renal functions. The New Zealand hematologists also stated that prescriber error accounted for about 25% of the bleeding complications citing a lack of physician awareness of the potentially serious side effects associated with Pradaxa use.

Less Serious Risks of Pradaxa

Even in those who don’t suffer serious bleeding events, they may have diarrheas as a side effect of Pradaxa or nausea and heartburn as a side effect of Pradaxa. Many users will have stomach pain or a very uncomfortable feeling in their stomach commonly known as dyspepsia. The stomach may be bloated, and the user may simply feel a general discomfort in the stomach. Because the active ingredient of Pradaxa is actually located on the outside of the capsule, formed around a shell of Tartaric Acid, the likelihood of gastrointestinal issues is fairly high. Since the active ingredient of Pradaxa needs an acidic environment to work, the manufacturers simply added their own source of acid to the drug which allows much quicker absorption of Pradaxa’s active ingredients.

Pradaxa Lawsuits

The first Pradaxa lawsuit was filed just this month against the manufacturer of Pradaxa, Boehringer Ingelheim, by Bertha Bivens who claims her mother died following a gastrointestinal bleed caused by Pradaxa only three months after beginning a Pradaxa regimen. As of November, 2011, over 260 deaths were attributed to Pradaxa, and all of these centered around unexpected and extreme bleeding. Soon after this first lawsuit was filed, five more quickly followed with many more expected.

If you have experienced the less serious gastrointestinal side effects of Pradaxa, you still should discuss the issue with your doctor. If you have experienced any unusual or prolonged bruising, bleeding gums, notice a pink or brown color to your urine, have experienced unexpected swelling or pain in your joints, have suffered a severe headache lasting much longer than normal, have had dizziness, weakness, red or black stools, recurring nosebleeds or heavier than normal periods, see your doctor immediately as these side effects could indicate internal bleeding.

Author: Sullo & Sullo Attorneys

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