If you are a patient who has been using the popular blood-thinner Pradaxa to ward off strokes or heart attacks there are important warnings from the Food and Drug Administration that may be vital to your health.
The FDA describes Pradaxa and another blood-thinner (warfarin) as important medications used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), the most common heart rhythm abnormality, which causes the heart (upper chambers or atria) to beat rapidly and irregularly.
“Although these drugs reduce the number of strokes in patients with non-valvular AF, they can cause bleeding, potentially leading to serious or even fatal outcomes,” warns the FDA. “The risk of bleeding is a well-recognized risk of anticoagulant drugs.
The agency also confirms that over 1,000 patient deaths have been blamed on Pradaxa bleeding incidents and that officials have received an incredible number of consumer reports of adverse effect from the use of the medication.
There have been so many tragic incidents that relatives and loved ones of people who allegedly died as a result of their use of Pradaxa and others who have suffered life-threatening bleeding problems have now filed nearly 3,000 Pradaxa bleeding lawsuits in our court system.
So, for those using Pradaxa, here is a vital safety checklist provided by the FDA:
Additional Information for Patients
- Pradaxa is an anticoagulant (blood-thinning) medicine that may help prevent blood clots from forming in your body and causing a stroke. Having a stroke, which is when the flow of blood to your brain is decreased or stopped, can cause permanent disability and death.
- Do not stop taking Pradaxa without talking to your healthcare professional first. Stopping use of anticoagulants 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 of the following signs or symptoms:
- unusual bleeding from the gums
- frequent nose bleeding
- heavier-than-normal menstrual or vaginal bleeding during your periods
- severe bleeding or bleeding you cannot control
- pink or brown urine
- red or black stools (may look like tar)
- bruises that happen or get larger without a known cause
- coughing up blood or blood clots
- vomiting blood or vomit that looks like coffee grounds
- Discuss any questions or concerns about Pradaxa with your healthcare professional.
- Report any side effects you experience to your healthcare professional and the FDA MedWatch program using the information in the “Contact Us” box.