Pradaxa, an anticoagulant and blood thinner medication prescribed to prevent strokes and atrial fibrillation (also known as abnormal heart rhythm). It works by inhibiting thrombin, an enzyme involved in the blood clotting process, thereby preventing the formation of a blood clot. Often prescribed as an alternative to warfarin, Pradaxa is also known by the generic name dabigatran etexilate mesylate. This medication is manufactured and sold by the German pharmaceutical company Boehringer Ingelheim AG.
Since its FDA approval in October, 2010, Pradaxa has been prescribed to more than 300,000 patients in the United States. However, recent research has linked Pradaxa to excessive bleeding, heart attacks, and other serious complications.
Pradaxa Bleeding / Hemorrhaging Side Effects
Research has shown that Pradaxa use can cause serious and sometimes fatal drug side effects. Recently, the FDA has become concerned that bleeding events associated with Pradaxa may occur more frequently than originally thought.
According to an FDA drug safety warning, published in December 2011, Pradaxa carries a risk of “serious bleeding events.” This can include the following side effects:
- Frequent nose bleeds
- Bleeding in the gums
- Heavier than normal menstrual bleeding
- Blood in urine, stool, or vomit
- Bruises that increase in size or are caused by unknown trauma
In some cases, the side effects of Pradaxa can be fatal. According to the drug manufacturer, Boehringer Ingelheim Pharmaceuticals Inc., at least 260 deaths have been linked to Pradaxa. Deaths linked to Pradaxa include those caused by the following serious complications:
Severe or uncontrollable bleeding (particularly internal bleeding or internal hemorrhaging) is among the most serious side effects of taking Pradaxa. The Randomized Evaluation of Long-Term Anti-coagulation Therapy (RE-LY), a clinical study designed to examine the effects of Pradaxa, up to 16.4% of people taking Pradaxa may experience bleeding. 3.3% experience serious bleeding and 1.5% experience life threatening bleeding.
Gastrointestinal problems are experienced by up to 35% of people prescribed Pradaxa. Such problems include abdominal pain, digestive tract ulcers, gastroesophageal reflux disease, black or tarry stools, indigestion, and more. While some of these side effects are considered minor, others constitute a serious medical emergency.
Heart attacks are another major side effect associated with Pradaxa. This blood-thinning medication is also associated with acute coronary syndrome, in which a plaque in a heart artery ruptures. Several clinical studies have found an elevated risk of heart attacks in people who take Pradaxa. According to one study, the risk of a heart attack or other heart complications rose 33% in patients taking Pradaxa.
Filing a Pradaxa Lawsuit
This drug has raised safety concerns in the United States and numerous other countries. Many patients who have taken Pradaxa and experienced adverse effects have filed lawsuits against the drug manufacturer or are currently considering doing so. If you have taken Pradaxa and believe that it harmed you, or a loved one passed away and you believe their death to be caused by Pradaxa, contact our lawyers to determine whether you should file a lawsuit against the drug manufacturer.
A legal claim against Boehringer Ingelheim can achieve compensation for damages such as medical bills, lost wages, future medical care, and pain and suffering. It also serves to hold the drug manufacturer accountable for the harm caused, and to warn others of the dangers associated with this drug.
Contact our Pradaxa Side Effects Lawyers
If you believe that you or a family member was harmed by taking Pradaxa, contact a lawyer today. Your lawyer can explain the legal process, assist you in filing a legal claim, and guide you through every step of the process of pursuing compensation from the drug manufacturer. Your attorney will be able to help you evaluate the extent of your damages and determine a monetary amount to pursue for compensation. A skilled attorney will also have access to medical experts and others who can help build a strong legal case, and can help you avoid being intimidated by the drug company and their lawyers.