Florida Pradaxa Lawyer
The Pradaxa lawyers of the Law office of Robert J. Fenstersheib and Associates are accepting extensive bleeding, including gastrointestinal and brain bleed cases resulting in death from Pradaxa.
Helping Victims of Extensive Bleeding From Pradaxa
Pradaxa is a blood thinner with no known antidote, and its use has been linked to extensive bleeding that can result in death. In January of 2012, the FDA reported that it had approved revised product labeling for Pradaxa. The labeling changes, which focused primarily on safety, reflect that at this time, there is no specific agent or medication that will reverse a Pradaxa bleed. Instead, the patient’s body must naturally eliminate Pradaxa by way of the renal (kidneys) system. In addition, the revised label reflects that Pradaxa’s anticoagulant (anti-clotting) activity and half-life are increased in patients with kidney impairment.
It has been suggested that patients older than 70 may need a lower dose of Pradaxa. Currently, the 110mg dose is recommended for patients 80 and older. According to the Reuters international news agency, Boehringer Ingelheim (the drug’s manufacturer) says it’s cooperating with the government on the warning, and that it is in the company’s best interest to have the medicine prescribed within the recommended guidelines.
FDA Safety Announcement For Pradaxa
(12/7/2011) The U.S. Food and Drug Administration (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.
Facts about Pradaxa (dabigatran etexilate mesylate)
What is Pradaxa?
Pradaxa is a blood thinner (anticoagulant) known as a direct thrombin inhibitor. The drug was approved to reduce the risk of stroke and blood clots (systemic embolism) in patients with non-valvular atrial fibrillation, and it is available as 75 mg and 150 mg oral capsules.
From approval in October 2010 through August 2011, a total of approximately 1.1 million Pradaxa prescriptions were dispensed and approximately 371,000 patients received Pradaxa prescriptions from U.S. outpatient retail pharmacies. The most common users of Pradaxa tend to be patients who were previously using Warfarin or Coumadin.
At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.
Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.
Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.
FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa. FDA is working closely with the manufacturer of Pradaxa (Boehringer Ingelheim) to evaluate the post-market reports of bleeding.
FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.
Additional Information for Patients
Pradaxa is an anticoagulant medicine that reduces the risk of blood clots forming in your body and causing a stroke. Having a stroke can cause permanent disability and death. Do not stop taking Pradaxa without talking to your healthcare professional. Stopping use of your blood thinner suddenly can put you at risk of a stroke. Be aware that while taking Pradaxa you may bruise more easily and it may take longer for any bleeding to stop.
Call your healthcare professional and seek immediate care if you develop any signs or symptoms of bleeding such as:
Lawyers at the Law Office of Robert J. Fenstersheib and Associates are accepting Pradaxa injury and wrongful death cases. If you or a loved one has encountered problems or suffered side effects from the use of Pradaxa, including bleeding that required a transfusion, or suffered an accident resulting in bleeding that could not be stopped because the patient was on Pradaxa, call the Pradaxa Lawyer Help Center Attorneys at the Fenstersheib Law Group, P.A. at 800-835-5762 & 954-456-2488 today. Our experienced team of attorneys can help evaluate your claim.