Pradaxa Recall & Warnings (dabigatran etexilate)
Origin and Purpose of Medication
Pradaxa (formerly Pradax) is a blood thinning medication used to lower the risk of stroke and blood clots in some patients.
Pradaxa (dabigatran etexilate) is an anticoagulant drug manufactured by Boehringer-Ingelheim Pharmaceuticals.
It is used to thin the blood in patients who are at risk of stroke from arterioscleroses, and has also been used to prevent blood clots in patients who have undergone surgery and have other risk factors that might lead to clot production.
Pradaxa is usually given to patients who have atrial fibrillation, a condition in which the atria of the heart does not contract as it should.
Pradaxa belongs to a class of drugs known as direct thrombin inhibitors. Thrombin is an enzyme produced by the body to help blood coagulate. Thrombin inhibitors, by suppressing the action of thrombin in the bloodstream, delay the formation of potentially deadly blood clots that can lead to strokes or other problems.
Pradaxa was first marketed as an alternative to warfarin, the drug commonly known as Coumodin, because it did not require the frequent monitoring necessary with other thrombin inhibitors.
Pradaxa was released with the approval of the Food and Drug Administration and promised to allow patients who were taking thrombin inhibitors to achieve a more successful result with fewer complications or frequent blood thrombin level checks.
Doctors were told that Pradaxa was safe for their patients and would lead to decreased incidents of thrombosis, or blood clots. However, problems soon developed with Pradaxa.
Because of the nature of the thrombin inhibitor, some patients developed uncontrolled intracranial bleeding and gastrointestinal bleeding. Worst of all, some patients suffered heart attacks, one of the very things Pradaxa was supposed to help prevent.
Pradaxa may contribute to other health problems as well. Many patients reported uncontrolled external bleeding after suffering a cut or abrasion. Some patients suffered from deep vein thrombosis as well.
Since the drug was released in 2011, the Federal Food and Drug Administration (FDA) has received reports of almost 1,000 serious injuries as a result of Pradaxa use. Over 500 of these patients needed hospitalization for their injuries, and there were a total of 120 serious complications and 25 deaths.
Pradaxa recall attorneys are currently working to assess the likelihood of successful lawsuits against the manufacturer. It is likely that the clinical trials leading to Pradaxa's release for public use may not have addressed all the possibly dangerous side effects or made doctors and patients aware of them. This now includes the FDA warning that patients with prosthetic heart valves not use the drug.
Pradaxa Mass Lawsuits
Pradaxa has been the target of a class action lawsuit started by a man in Tennessee who developed internal bleeding after taking the drug for several weeks. Hundreds have since joined in to take legal action against the drug-maker which saw sales of over $1 billion in 2011. Stories from patients and their loved ones have littered blogs across the Internet with questions of why.
One commenter on the USA Today blog said her mother had fallen down the stairs and received a laceration to the back of her head, but because she had been on Pradaxa for six months, doctors were unable to stop the bleeding. She has since reatained a products liability attorney. She said she is still trying to make sense of why this happened.
If you were injured using Pradaxa, talk to a recall lawyer immediately who specializes in pharmaceutical litigation. It is important that you receive immediate medical help and supervision for your injuries and that you discuss options for thrombin inhibitors with your doctor. There are alternatives to Pradaxa that may have fewer side effects or which your body can tolerate more easily.
Call 949-203-3814 for Immediate Help or request a free case review online.