Tuesday, March 27, 2012

The Dangers of Pradaxa (Dabigatran): Part 1 of 3: Side Effects and Complications

The newest drug approved for use in the treatment of heart valve problems or atrial fibrillation among patients with an increased risk of stroke is the drug Pradaxa, manufactured by Boehringer Ingelheim. The drug Boehringer is seeking to replace with its newest arrival is Warfarin—a blood-thinning drug which has been used since the early 1950’s. Boehringer claims that Pradaxa is over 30% better in decreasing the risk of a serious stroke than Warfarin. The FDA initially agreed with Boehringer, granting FDA approval of Pradaxa in October of 2010.

What is Atrial Fibrillation and How Does Pradaxa Help?

Atrial fibrillation affects over two million Americans and involves excessively rapid, uncoordinated contractions of the upper two chambers of the heart. Those with atrial fibrillation are at a much higher risk of developing blood clots which in turn can lead to a disabling stroke should the clot travel to the brain. Pradaxa works by inhibiting thrombin, an enzyme in the blood which controls blood clotting.

Excessive Bleeding as a Pradaxa Side Effect?

In the initial trials, Pradaxa users suffered fewer strokes than patients taking Warfarin. Pradaxa also appeared to have other benefits over Warfarin in that Warfarin users must undergo blood test monitoring and must be more cautious in what foods and other medications they take while on Warfarin. Unfortunately, one of the primary issues with either drug involves Warfarin or Pradaxa internal bleeding. When the patient taking Warfarin experiences excessive bleeding, doctors can reverse the effects of the bleeding through injections of Vitamin K, however no such antidote exists to reverse the effects of Pradaxa when excessive bleeding occurs.

Gastrointestinal Dangers of Pradaxa

As with any prescription drug, side effects are possible and even likely. Pradaxa users may have an uncomfortable feeling in their stomach known as dyspepsia, pain in the stomach, excessive heartburn or nausea or bloating in the stomach. It has been suggested that Pradaxa may cause gastrointestinal effects due to the fact that, unlike most drugs, the active ingredient of Pradaxa is actually on the outside of the capsule, forming a shell around a Tartaric Acid Core. This core, once released, creates an acidic environment in the intestinal tract which allows quick absorption of the Pradaxa active ingredients.

More Serious Pradaxa Complications

More serious Pradaxa complications can include uncontrolled bleeding, potentially leading to death. If you are taking Pradaxa and experience any bruising that is unusual or unexpected, notice a pink or brown tinge to your urine, have unexpected swelling or pain in your joints, have a serious headache which lasts a long time, dizziness or weakness or red or black stools you must see your physician immediately as this can indicate internal bleeding. If you have any unusual bleeding in the gums, recurring nosebleeds, or a heavier than normal period you should also seek advice from your doctor. Those patients who are over the age of 75 or have kidney problems or a stomach ulcer should use caution when taking Pradaxa, as these issues make the likelihood of Pradaxa side effects and risks much more likely. Those whose kidney function is less than optimal could experience a greater incidence of Pradaxa side effects since the kidneys are responsible for flushing out excess Pradaxa from the body.

Fatal Effects of Pradaxa

Intra-articular bleeding, pericardial bleeding, subdural bleeds, intracranial hemorrhage and hemorrhagic stroke are all potential fatal effects of taking Pradaxa. The Pradaxa works as a blood clot inhibitor to prevent clots from forming in a different manner than Warfarin or Coumadin. Warfarin is a Vitamin K adversary which prevents the formation of blood clots by intervening in the body’s Vitamin K production. Pradaxa, on the other hand works by inhibiting thrombins which are naturally occurring proteins in the body which encourage clot formation. With no known antidote to the effects of Pradaxa, bleed-outs can happen so swiftly that death occurs before measures can be taken to prevent it. There also currently exists no known method for measuring the anticoagulant effect of Pradaxa, while Warfarin anticoagulant effects can be tested in those taking the older drug.

Negative Reports of Serious Effects of Pradaxa

Agencies outside the United States have taken a harder stance against Pradaxa; in Europe patients whose physicians recommend Pradaxa are advised to first have their kidneys checked since an elderly patient with less-than-optimal kidney function has a much higher risk of suffering from internal bleeding. Europe has reported 21 cases of bleeding deaths related to Pradaxa while Japan has reported 14 cases. Japanese regulators have insisted that the manufacturer of Pradaxa issue strong warnings to physicians regarding the potential for deadly bleeding, especially in older patients.

FDA Stance

A letter which was published in a medical journal, Therapeutics Initiative, stated Boehringer was aware of significant flaws in their initial Pradaxa drug trial but overlooked certain issues in order to gain FDA approval. Despite over 260 deaths worldwide which have been definitively linked to Pradaxa use, the American FDA continues to take a more cautious approach. Although the FDA issued a safety review in December of 2011and is reviewing all reports of serious bleeding in patients using Pradaxa, they continue to state that patients using Pradaxa should continue for now and that Pradaxa offers “an important health benefit when used as directed.”

Lawsuits against Pradaxa Manufacturers

Three lawsuits have been filed against the manufacturers of Pradaxa this month, and it is believed that many more are to come. Many believe that Boehringer should have placed a warning on their “wonder drug,” making physicians and patients aware that there currently exists no quick way to manage a bleed in the body caused by Pradaxa. It is likely that Boehringer will be held responsible for failing to adequately warn those taking Pradaxa of the myriad of potential risks, some of them fatal.

Anyone taking Pradaxa, particularly those who are over the age of 75 or who have a history of kidney problems should be aware of the risks when taking this drug. As more time passes more and more reports are coming in of Pradaxa users who have suffered gastrointestinal bleeding, cerebral bleeds or vascular and cardiovascular health issues. If you have suffered a health issue after using Pradaxa, speak with your physician to determine if Pradaxa was responsible.

Author: Sullo & Sullo Attorneys

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