Internal bleeding has been suspected of occurring more often in patients taking the blood thinner Pradaxa® than in patients taking another anticoagulant drug warfarin.
Both medications are prescribed to prevent stroke in patients who have atrial fibrillation not associated with heart valve disease. Atrial fibrillation is the extremely rapid contraction of the atria (the two upper chambers of the heart) in an abnormal rhythm and can lead to blood clots and stroke. It is the most common kind of heart rhythm abnormality, according to the U.S. Food and Drug Administration (FDA).
The FDA issued a safety alert Dec. 7, 2011 saying it is evaluating reports of serious bleeding events in patients taking Pradaxa®. The reports are being made by doctors whose patients have experienced the bleeding after the new drug went on the market in October 2010.
The agency said it is working closely with the drug manufacturer Boehringer Ingelheim to assess the post-marketing reports and determine if bleeding is actually occurring more often than would normally be found. In a large clinical trial involving 18,000 patients bleeding caused by Pradaxa® was the same as was caused by warfarin.
For patients who have atrial fibrillation not involving the heart valve (non-valvular AF), the primary alternative to Pradaxa® is warfarin. Warfarin has been on the market for more than 50 years.
The FDA noted in its safety alert that some bleeding is an expected result in some patients taking an anticoagulant.
Patients are advised to be aware of the following signs and symptoms that internal bleeding may be occurring:
- Unusual bleeding from the gums
- Frequent nose bleeds
- Heavier than normal menstrual bleeding
- Pink or brown urine
- Red or black (tar-like) stools
- Bruises that occur without you’re knowing why or that become larger
- Coughing up blood or blood clots
- Vomiting blood that appears like coffee grounds
The FDA warns patients not to discontinue taking Pradaxa® without first talking with their physicians.
Source: FDA
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