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Pradaxa Lawsuits
Pradaxa is a blood thinning medication prescribed by physicians to reduce the risk of strokes in patients with non-valvular atrial fibrillation, the most common type of heart rhythm abnormality. In November of this year, the European Medicines Agency stated that it was aware of 256 cases of serious bleeding resulting in patient deaths. Pradaxa (the generic name of the drug is dabigatran) is made by Boeheringer Ingelheim. Less than a month later, the FDA decided to investigate post marketing reports of serious bleeding in patients in the U.S, and it is reported that the FDA was alerted to 505 cases of hemorrhaging associated with the drug in the first quarter of 2011.
Pradaxa was approved for sale to the U.S. market in October 2010. A total of approximately 1.1 million Pradaxa prescriptions have been dispensed and approximately 371,000 patients have received prescriptions since market approval. It was reported by the Institute for Safe Medicine Practices recently that within weeks of its approval it moved to near the top of their adverse event rankings, with more reports than 98.7% of the drugs that they regularly monitor.
Potential Injuries from Pradaxa
Internal bleeding is the most serious side effect being reported from the usage of Pradaxa. The RE-LY clinical trial found that up to 16.4% of users of the drug may experience bleeding. A recent case report in the March 2012 Journal of Neurosurgery indicates that the bleeding complications brought on by Pradaxa may be irreversible. This is particularly worrisome considering that the patients receiving the drug are often elderly and susceptible to falls. The Journal report related the case of an elderly man on Pradaxa for a month who fell, suffered relatively minor head trauma, which then progressed to serious brain hemorrhaging and death.
It has also been reported that up to 35% of people taking Pradaxa may develop gastrointestinal problems. These problems could include abdominal pain, ulcers, gastroesophageal reflux disease, to name a few.
You may have a higher risk of bleeding if you take PRADAXA and:
• are over 75 years old
• have kidney problems
• have stomach or intestine bleeding that is recent or keeps coming back, or you have a
stomach ulcer
• take other medicines that increase your risk of bleeding, including:
o aspirin or aspirin containing products
o long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
o warfarin sodium (Coumadin®, Jantoven®)
o a medicine that contains heparin
o clopidogrel (Plavix®)
o prasugrel (Effient®)
• have certain kidney problems and also take the medicines dronedarone (Multaq®) or
ketoconazole tablets (Nizoral®)
The FDA recommends that you call your healthcare professional and seek immediate care if you develop any signs or symptoms of bleeding such as:
- unusual bleeding from the gums
- nose bleeding that happens often
- menstrual or vaginal bleeding that is heavier than normal
- bleeding that is severe or you cannot control
- pink or brown urine
- red or black stools (looks like tar)
- bruises that happen without a known cause or that get larger
- coughing up blood or blood clots
- vomiting blood or vomit that looks like coffee grounds.
Contact the Taylor Law Firm
If you have been injured from the use of Pradaxa please contact the Taylor Law Firm. The defective drug attorneys at the Taylor Law Firm are experienced in litigation and Mobile drug recall lawyer, Jerry Taylor has handled thousands of lawsuits against large drug manufacturing companies. You can contact the Taylor Law Firm for a free consultation to discuss your legal options. We represent clients nationwide, including the states of Alabama, Florida and Mississippi, as well as the cities of Mobile, Pensacola, Pascagoula, Biloxi and Gulfport.
