In October of 2010, The United States Food and Drug Administration (FDA) approved clot fighting drug Pradaxa as a method of preventing strokes and blood clots in patients diagnosed with atrial fibrillation, a syndrome responsible for irregular heart rhythms. Recently, however, Pradaxa has been the subject of numerous lawsuits over internal bleeding side effects that question Pradaxa's safety.
Pradaxa is the brand name given to dabigatran etexilate, which is an anti-clotting medication intended to inhibit the clotting enzyme known as thrombin.
Over 2 million Americans suffer from atrial fibrillation. Among the most prevalent heart rhythm irregularities, atrial fibrillation occurs when the two uppermost chambers of the heart fail to synchronize their contractions.
Blood clotting is recognized as one of the most serious dangers posed by atrial fibrillation, and a single clot has the ability to cause a stroke if it reaches the brain. Strokes can result in severe cognitive impairment, paralysis and even death.
In clinical trials, subjects who took Pradaxa experienced fewer strokes than those who were given warfarin, which is an alternative type of anti-clotting drug. Also known by the brand name Coumadin, warfarin is frequently prescribed to patients in the United States.
The trials were meant to assess the safety and potency of Pradaxa, manufactured by Boehringer Ingelheim Pharmaceuticals, and produced seemingly impressive results.
After receiving FDA approval, Boehringer Ingelheim announced plans to manufacture the drug in 75 milligram and 150 milligram capsule forms.
Whereas patients who have been prescribed warfarin must submit to regular blood testing, those taking Pradaxa do not need additional monitoring, according to the FDA.
Common side effects of Pradaxa include bleeding, sometimes of a severe or even fatal nature, though similar effects have also been observed in patients who have taken other anti-clotting drugs.
Given the serious nature of the possible consequences of taking Pradaxa, informative materials advising patients of the potential risk of severe bleeding will accompany the drug every time it is dispensed by a pharmacist. The mandatory warning was a condition of FDA approval.
Among the additional side effects reported by patients taking Pradaxa are heartburn, stomach discomfort, bloating and nausea.
Pradaxa Side Effects Lawsuits: Have You Experienced Internal Bleeding After Taking Pradaxa?
If you have taken Pradaxa and suffered from internal bleeding, you may be entitled to collect significant financial compensation by participating in the Pradaxa lawsuits. To find out if you have a case, contact our expert Pradaxia side effect lawyers for a free no obligation consultation by completing the form on this page or calling 1-800-905-2751.