Pradaxa Regulatory Histories: Australia and New Zealand, Europe, and Canada.
Below are several resources regarding safety reviews, side effects, related lawsuits, and usage recommendations.
The FDA announced in December 2011 that it was initiating a safety review of Pradaxa. The review was prompted by reports of serious bleeding events in people taking the drug.
An elderly man taking Pradaxa for atrial fibrillation died as a result of brain hemorrhage following a ground-level fall. There are currently no effective reversal agents for use in the event of traumatic bleeding in patients taking Pradaxa.
- Pradaxa Bleeding Death Detailed in Medial Journal Report
- Death Magnifies Pradaxa Hemorrhage Concerns
- New Anticoagulant Drug and Head Injury: Do Not Mix
The U.S. Food and Drug Administration released safety information regarding proper storage and handling of Pradaxa. It advises that Pradaxa be dispensed and stored only in its original bottle or blister package due to the potential for product breakdown from moisture and loss of efficacy.
Side effects of Pradaxa can include serious internal bleeding and hemorrhaging. Symptoms of these life-threatening effects include gum and nose bleeding, bruising, blood in the urine and stool, and dizziness and lethargy among others.