According to Medscape, the FDA announced on May 13 that based on the results of a study of 134,000 Medicare patients, Pradaxa was associated with a reduced risk for some conditions compared to warfarin, but an increased risk for major gastrointestinal bleeding resulting from the use of the anticoagulant. The risk of bleeding is typically higher among:
- Patients 75 years old or older
- Those who have had kidney problems
- Patients who suffer from recurrent stomach or intestinal bleeding or stomach ulcers
- Those who take other medications that increase their risk of bleeding (aspirin products and anti-inflammatory drugs) and blood thinners
- Those who have kidney problems and take dronedarone or ketoconazole tablets
What is Pradaxa?
Pradaxa is a prescription blood thinner medication prescribed to lower the risk of blood clots forming in the body. It is used to reduce the risk of stroke and blood clots in people who suffer from atrial fibrillation, a condition in which part of the heart does not beat the way it should, leading to blood clots and an increased risk of stroke. Pradaxa is also used to treat deep vein thrombosis and pulmonary embolism and reduce their risk of occurrence. People should not take Pradaxa if they:
- Currently suffer from abnormal bleeding
- Have ever had an allergic reaction to it
- Have or plan to have a valve in their heart replaced
You should call your doctor immediately if you are experiencing any of the following signs or symptoms:
- Unexpected, severe, uncontrollable, or long-term bleeding
- Unusual or unexpected bruising
- Coughing up or vomiting blood
- Vomit that resembles coffee grounds
- Pink or brown urine
- Red or black stools resembling tar
- Unexpected pain or swelling
- Joint pain
Since its approval in 2010, Pradaxa has been the subject of numerous safety questions and inquiries. According to the FDA, since Pradaxa’s approval, U.S. pharmacies have dispensed about 6.2 million prescriptions of the medication for 934,000 patients. The FDA warns that patients should not stop taking Pradaxa or warfarin without first talking with their healthcare professionals, as abruptly discontinuing use can increase the risk of stroke and lead to permanent disability and death.
According to the German drug maker Boehringer Ingelheim, the manufacturer of Pradaxa, the company is currently facing more than 2,000 lawsuits in the U.S. filed by individuals alleging that the drug caused severe or fatal bleeding.
If you have suffered uncontrollable bleeding or if your loved one lost life due to bleeding after taking Pradaxa we can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation to learn more about your legal rights and options. Our experienced drug injury lawyers will work closely with you and fight for the maximum compensation for your injuries.