Information regarding Pradaxa and reasons it is prescribed.
Pradaxa (dabigatran etexilate mesylate) is a prescription anticoagulant medication used to prevent strokes and blood clots in people with an irregular heart rhythm known as atrial fibrillation. It belongs to a group of medications known as direct thrombin inhibitors. The prescription drug is made and sold by the German pharmaceutical company Boehringer Ingelheim AG, and is used to treat strokes and systemic embolism in those who suffer from non-valvular atrial fibrillation. The U.S. Food and Drug Administration (FDA) approved the drug in October 2010, and it is sold in 75 mg and 150 mg oral capsules taken twice daily.
According to the FDA’s Pradaxa label, Pradaxa belongs in the “direct thrombin inhibitor” drug class. Thrombin is one of the enzymes involved in the blood clotting process, and it facilitates the conversion of fibrinogen into fibrin, a clotting protein. By inhibiting this process, Pradaxa prevents the formation of a “thrombus,” the medical term for a blood clot.
Potential side effects of Pradaxa.
The FDA has issued two drug safety communications related to Pradaxa. The first, released on March 29, 2011 concerned the storage of the drug. The second, published December 7, 2011 warned the public that Pradaxa might cause “serious bleeding events.”
The Pradaxa label also refers to a study, the Randomized Evaluation of Long-term Anticoagulant Therapy (RE-LY), which determined that life-threatening bleeding events occurred at an annualized rate of 1.5 percent as opposed to 1.8 percent for warfarin, an older, commonly used anticoagulant. More recently, the FDA has become concerned that Pradaxa bleeding events are more common than it originally believed.
The FDA Safety Announcement on December 7, 2011 also stated there is a concern that Pradaxa bleeding side effects include the following:
Bleeding side effects include the following:
- unusual bleeding from the gums
- nose bleeding that happens often
- menstrual or vaginal bleeding that is heavier than normal
- bleeding that is severe or you cannot control
- pink or brown urine
- red or black stools (looks like tar)
- bruises that happen without a known cause or that get larger
- coughing up blood or blood clots
- vomiting blood or vomit that looks like coffee grounds.
These Pradaxa side effects can potentially be FATAL.
Information about Pradaxa class actions and individual lawsuits.
The attorneys at our firm are reviewing potential Pradaxa class action lawsuits and individual injury lawsuits for people throughout the United States. We believe, at this time, it may be more beneficial to file individual lawsuits since every person will have different injuries. To have a case evaluated by one of our Pradaxa lawyers, request a free consultations and case evaluation.
Free Pradaxa case evaluation by our qualified drug injury lawyers.
Our intakes are always confidential. By submitting information to our firm you are not obligated to hire our attorneys to represent you in a potential lawsuit. We handle all cases on a contingency fee basis. In simple terms, this means that you will make no payment for our legal services until after we have succeeded in getting legal compensation for you.