Pradaxa is a prescription drug used to prevent the formation of blood clots that can increase the risk of strokes in patients with atrial fibrillation (nonvalvular).
The U.S. Food and Drug Administration is monitoring Pradaxa for an increased risk of serious or fatal bleeding, as are drug regulatory agencies worldwide.
The European Medicines Agency reported that as of Nov. 6, 2011, a worldwide total of 256 cases of serious bleeding resulting in death was reported in association with Pradaxa therapy.
In December 2011, the FDA stated that it was evaluating reports of serious bleeding and deaths in patients taking Pradaxa. It advised patients who had suffered adverse effects after taking Pradaxa not to stop taking the drug due to the risk of stroke but encouraged them to call their health care professionals immediately.
A Pradaxa injury lawyer should also be consulted to learn about this potentially dangerous drug.
Adverse effects of Pradaxa include:
- Unusual bleeding from the gums
- Heavier than normal menstrual or vaginal bleeding
- Severe or uncontrollable bleeding
- Pink or brown urine
- Coughing up blood or blood clots
- Vomiting blood
- Heart attack
In January 2012, the FDA approved a revised product information label for Pradaxa warning that at this time, there is no specific agent or medication that can reverse bleeding due to Pradaxa and that the body must eliminate it, naturally, by way of the renal system.
In April 2013, the FDA put a black box warning on Pradaxa. This is the strongest warning by the FDA and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.
The Pradaxa black box warning is meant to ensure that patients do not suddenly discontinue use of the drug without consulting their doctor or taking a replacement drug because doing so causes an increased risk of stroke or blood clots.
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If you or a loved one has taken Pradaxa and experienced any of the above reactions, please contact us today.
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