Update from the FDA is Met with Criticism
The FDA has recently announced that following their assessment of the drug, Pradaxa users did not find an increased risk of bleeding in relation to the use of the associated drug, warfarin. While this information is true, theFDA failed to state that the drug warfarin includes a reversal agent which would be critical if a bleeding emergency were to occur. Pradaxa, in contrast, does not include an antidote which would be essential for anti-clotting and the stoppage of severe and perhaps fatal bleeds.
If you or a loved one has suffered from using Pradaxa, do not hesitate to contact the Pradaxa injury lawyers at The Eichholz Law Firm for a free and confidential case evaluation.
Pradaxa was first approved for use in the U.S. in October 2010. It was designed to prevent strokes in patients who suffer from atrial fibrillation, an irregular heartbeat condition common among the elderly. It works by inhibiting the enzyme that is responsible for clotting blood. However, sometimes it works too well. When a patient who is using a drug like Pradaxa suffers a serious bleeding event, their blood fails to clot and can sometimes lead to the patient bleeding to death.
The FDA is not the only one concerned with Pradaxa internal bleedingdeaths. European regulators have recommended that patients who are about to start a Pradaxa regimen should first have their kidneys checked.
An individual with weakened kidneys has a higher risk of suffering internal bleeding. Japanese regulators required Boehringer to issue a strong warning to physicians regarding the potentially deadly bleeding caused by the use of Pradaxa.
Symptoms of Pradaxa Internal Bleeding
Similar to other anti-blood-clotting drugs, Pradaxa’s benefit of reducing the chance of a debilitating or fatal stroke comes with the risk of internal bleeding. If you or a loved one has taken Pradaxa and has experienced any of the following symptoms, contact your doctor immediately:
- Unusual bruising or bleeding
- Red or black tarry stools
- Pink or brown urine
- Vomiting that either looks like coffee grounds or resembles blood
- Coughing up blood
- Frequent nosebleeds
- Joint pain or swelling
- Weakness and swelling of the hands feet, arms, ankles or lower legs
Other Adverse Side Effects of Pradaxa
In addition to the risk of internal bleeding, Pradaxa has been linked to an increased risk of heart attack. Studies have shown that the risk of heart attack for Pradaxa patients with atrial fibrillation is 38 percent higher than those who take comparable anti-blood-clotting drugs.
Other serious side effects associated with Pradaxa include stomach pain, nausea and gastrointestinal symptoms like dyspepsia.
At The Eichholz Law Firm, we believe that when a pharmaceutical company puts patients at risk with their products, they should be held accountable. If you or someone you love has suffered from internal bleeding after taking Pradaxa, contact the Pradaxa lawsuit lawyers as soon as possible. You may be eligible to receive compensation for medical bills, lost wages, pain and suffering. If a loved one has passed away due to Pradaxa side effects, their dependents may be able to collect wrongful death damages.
Recovering from losses caused by dan
gerous drugs is difficult. The last thing you want to worry about while you’re recuperating is your financial stability. Let us help.
Contact our Georgia Pradaxa lawyers today. A member of our team will be able to assess your claim and guide you on your next course of legal action.
Pradaxa Recalled Over Packaging Defect
Boehringer Ingelheim Pharmaceuticals, Inc. is conducting a nationwide voluntary recall of a single manufacturing lot of Pradaxa® (dabigatran etexilate mesylate), 75mg 60 US, NDC 0597- 0149-54, lot 201900, Exp. Jan. 2015. Pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).
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