While lawsuits mount against the anti-clotting drug Pradaxa, the manufacturer is filing for FDA approvals to market the drug for additional purposes. Bloomberg Businessweek reports that the U.S. Food and Drug Administration (FDA) has accepted a marketing application from German pharmaceutical company Boehringer Ingelheim, makers … Full Story
Pradaxa® (Dabigatran Etexilate)
Pradaxa® (generic drug name, dabigatran etexilate) is a prescription medication used for anticoagulation. It was approved for use in the U.S. by the Food and Drug Administration (FDA) in October 2010. By December of 2011, the FDA had started an investigation into the many life-threatening bleeding events linked to Pradaxa®. One month earlier, the maker of Pradaxa® — Boehringer Ingelheim — acknowledged that there had been 260 fatal bleeding events linked to the drug.
What Is Pradaxa® Used For?
Pradaxa® is used for the prevention of strokes in patients who have a cardiac condition called nonvalvular atrial fibrillation. The disorder atrial fibrillation (AF) is a type of irregular heartbeat, and the term "nonvalvular" means that the patient does not have, for example, a prosthetic heart valve or rheumatic mitral valve disease, and has not undergone mitral valve repair.
The prevention of strokes in the population of people with nonvalvular AF is a very important and worthwhile endeavor. A stroke occurs when the supply of blood going to the brain is interrupted. Strokes among individuals the U.S. are the leading cause of adult disability and the second leading cause of death.
Potential Side Effects
Pradaxa® has some very troubling side effects. Although every drug known to humankind has potential side effects (at least for some of the people who take it), one of Pradaxa®'s most dangerous potential side effects is fatal heart attacks.
Other potential side effects of Pradaxa® include:
- bleeding that lasts a long time and/or can't be stopped
- unexpected bleeding
- bleeding that is out of control
- bruises that appear without cause
- bruising more easily
- frequent and unexplained nose bleeds
- heavier-than-normal menstrual bleeding
- coughing up blood clots
- dizziness, headaches
- vomiting blood
- vomit that looks like coffee grounds
- pink or brown urine, red or black stools
- unexpected pain, swelling, or joint pain
Talk with a Pradaxa® Lawyer
Individuals whose health has been damaged by Pradaxa® have the option of taking legal action. If you or a loved one has suffered a heart attack, serious bleeding event, or other side effect you feel is linked to Pradaxa®, contact our Pradaxa® attorneys for help today.
An increasing number of lawsuits, including wrongful deaths, are being filed against Boehringer Ingelheim, makers of the blood thinner Pradaxa, due to internal bleeding. DrugNews.org reports that Brenda Medley has filed a wrongful death lawsuit in the U.S. District Court of Eastern Missouri on behalf … Full Story
Pradaxa® has been linked to life-threatening bleeding events, but the U.S. Food and Drug Administration (FDA) continues to keep the drug on the market. The agency issued a safety announcement last year to notify health care providers and patients of its plan to evaluate reports … Full Story