Pradaxa (dabigatran)
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The FDA issued a Safety Communication on December 7, 2011, on the use of Pradaxa to prevent stroke in patients with atrial fibrillation. While the risk of serious bleeding is known to be a side effect of any blood thinner, post market reports indicate that Pradaxa may cause serious bleeding more often than expected.
Pharmaceutical drug manufacturers, including the makers of Pradaxa, Boehringer Ingelheim, may be held liable when their drugs cause injuries to patients. This is especially true where, as in the case of Pradaxa, they do not inform doctors and patients of all the potential risks, side effects and dangers.
The undisclosed increased risk of a Pradaxa heart attack or death from Pradaxa internal bleeding has resulted in numerous Praxa lawsuits being filed. These lawsuits allege that the maker of Pradaxa did not provide adequate warnings to Pradaxa users regarding the increased risks.
The FDA approved warning associated with Pradaxa and used by the manufacturer, lists the the most common signs or symptoms of potential internal bleeding or hemorrhaging associated with the medication. The FDA warning signs are:
- External bleeding (through orifices like the mouth or nose)
- Bruising (not attributable to any external cause)
- Coughing up blood
- Brown or pink tint to urine
- Joint pain
- Joint swelling
- Vomiting (producing an expulsion with consistency of coffee grounds)
- Headaches
- Dizziness
Alone, or in combination, a patient taking Pradaxa must seek prompt medical attention if these symptoms appear. A patient does not need to take the medication for an extended period of time before experiencing adverse side effects according to both the FDA and USA Today.
How Do I Document My Claim
It will speed up the process if you have the following information available before you contact us:
- Consult your doctor immediately if you suspect an injury. Follow the medical instructions of your doctor or a qualified medical professional.
- Keep a notebook detailing the injuries you or a loved one has suffered, with dates and symptoms documented.
- Keep track of your prescriptions for Pradaxa, note the dosage you have taken and the time period over which you took the drug.
- Keep any containers of Pradaxa and make a note of the pharmacies where you had your prescriptions filled.
- If possible, document your injuries with pictures or other evidence.
Our firm works on a contingency basis which means you will not be asked to pay any money out of pocket.
This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.
This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.
Known Pradaxa Side Effects
Pradaxa is a medication prescribed for people over the age of 18 diagnosed with atrial fibrillation not caused by valve disease. In all cases, Pradaxa use must be monitored, and side effects should be reported to the prescribing physician immediately.
Some side effects may be fatal.
- Nausea, indigestion and/or burning sensations in the stomach
- Pain localized to the stomach
- Allergic reactions
- Uncontrollable internal and/or external bleeding
Allergic Reactions to Pradaxa:
Some individuals experience the symptoms of an allergic reaction during their first use of Pradaxa. However, these symptoms can occur at any time. Mild symptoms include skin rashes and itching, hives and itching. These may go away or develop into worse symptoms. Any serious symptom(s) should be reported to the doctor immediately. They include:
- Wheezing and difficulty breathing
- Swelling in the face or tongue
- Fainting or dizziness
- Pain or tightness in the chest
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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