Pradaxa: A Brief Overview

Pradaxa - blood enzyme

For those patients with heart valve problems or atrial fibrillation who are at a significantly elevated risk of stroke, the drug Pradaxa (Dabigatran), approved by the FDA merely twenty-eight months ago appeared to be a good solution to these medical issues.

Pradaxa (Dabigatran) falls under a group of drugs known as direct thrombonin inhibitors which work by limiting the actions of a specific blood enzyme which is crucial to the blood clotting process. Pradaxa (Dabigatran) is indicated for use as an anti-coagulant, along the lines of the drug Warfarin, although the makers of Pradaxa (Dabigatran), Boehringer Ingelhem, claim their drug is at least 35% more effective in reducing the risk of stroke than Warfarin. Since the kidneys are responsible for expelling Pradaxa (Dabigatran) from the body, increased quantities of the drug can remain in the body when kidney function is not optimal, leading to potential bleeding problems.

First Anticoagulant Approved in Half a Century

When Pradaxa (Dabigatran) was approved, it became the first approval by the FDA of a new oral anticoagulant in the U.S. in more than 50 years. The FDA approval was largely based on findings from one of the largest trials completed to date which demonstrated that administering Pradaxa (Dabigatran) in dosages of 150 mg effectively reduced the risk of stroke and embolism by 35% over warfarin, additionally offering reductions in intracranial bleeding.

Based on this particular study, the FDA stated that those taking Pradaxa (Dabigatran) did not require monitoring or related dosage adjustments, and that Pradaxa (Dabigatran) had not been found to be affected by food. This clinical trial also suggested that approximately 16% of all people taking Pradaxa (Dabigatran) could experience some level of internal hemorrhage, and the labeling on the box warns against an increased rate of GI bleeds with dosages of 150 mg. Warfarin users in contrast have only a 6% risk of experiencing internal hemorrhage. The warning on Pradaxa (Dabigatran) also states that the threat of a fatal bleed is significantly higher in those patients who are aged 75 or older.

Negative Reports

As of this date, Europe has reported 21 cases of bleeding deaths related to Pradaxa (Dabigatran), Japan has reported 14 such cases with an additional 225 instances from other countries. Data from Boehringer state these deaths occurred between March of 2009 and October of 2011. The Pradaxa (Dabigatran)-related deaths prompted the FDA to issue a statement in December of 2011 which indicates that Pradaxa (Dabigatran) imparts significant benefits to overall health when used according to a physician’s instructions however reports of fatal hemorrhages were simultaneously being investigated.

Three months prior to the FDA’s statement the European Medicines Agency issued a stronger warning regarding the use of Pradaxa (Dabigatran) to all physicians, stating the necessity of being extremely cautious when prescribing the drug to older patients or those who have prior histories of renal impairment. Also in October of 2011 a letter published in the medical journal, Therapeutics Initiative, pointed out flaws in the trials used by Boehringer to obtain critical FDA approval. Even earlier, in August of 2011, Japanese specialists requested that Boehringer caution physicians and patients regarding using Pradaxa (Dabigatran) in patients older than 75. They issued this request when 14 out of 64,000 elderly patients on the drug died due to excessive hemorrhaging.

Side Effects from Pradaxa (Dabigatran)

Other possible side effects of the drug aside from internal and gastrointestinal bleeding include brain hemorrhages and kidney bleeds. The FDA warns against stopping the drug without consulting a physician, however also states that immediate medical attention should be sought in the case of unusual bleeding of the gums, frequent nose bleeds, unusually heavy menstrual bleeding, urine which is pink or brown colored, unexplained bruising, vomiting blood, or red or black stools which look like tar. If you’ve experienced negative effects from taking Pradaxa (Dabigatran) you may want to consult a personal injury attorney who can evaluate your particular circumstances and discuss the possibility of a lawsuit against the manufacturers of Pradaxa (Dabigatran).

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