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 pradaxa 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 issues. 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. Read more