Pradaxa Use
Pradaxa is a blood thinning agent (anticoagulant) that is prescribed to reduce the risk of stroke in patients with non-valvular atrial fibrillation. Pradaxa is manufactured by Boehringer Ingelheim. The U.S. Food and Drug Administration, FDA, approved Pradaxa on October 19, 2010.
FDA Safety Communication Regarding Pradaxa Serious Bleeding Events
In a Safety Communication dated December 7, 2011, the FDA stated that it is currently evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). While bleeding is a known complication of blood thinning medications, the FDA wishes to determine if life threatening bleeding complications occur more commonly with Pradaxa than would be expected.
Because Pradaxa is prescribed to reduce the risk of blood clot formation the FDA advised that patients should not stop taking Pradaxa without talking to their healthcare professional first. The FDA also advised that patients should call their healthcare professional and seek immediate care if they develop any signs or symptoms of bleeding such as:
- Unusual bleeding from the gums
- Nose bleeding that happens often
- Menstrual or vaginal bleeding that is heavier than normal
- Bleeding that is severe or that 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
In addition to the FDA’s efforts, Pradaxa is being monitored for an increased risk of serious or irreversible bleeding by drug regulatory agencies worldwide. According to the European Medicines Agency as of November 6, 2011, a worldwide total of 256 spontaneous case report of serious bleeding resulting in death were recorded in association with the use of Pradaxa.
Pradaxa Bleeding Risks and Irreversible Bleeding
In January of 2012 the FDA posted on its website revised product labeling for Pradaxa. The revised label indicates that at this time, there is no specific agent or medication that will reverse a Pradaxa bleeding event. Instead, the patient’s body must eliminate Pradaxa via the renal (kidney) system. Further complicating this matter is that Pradaxa’s anticoagulant (blood thinning) activity and half-life are increased in patients with kidney impairment.
The FDA site has this information:
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) |
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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 (SeeAdditional Information for Healthcare Professionals).
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.
