Pradaxa Side Effects: Internal Bleeding, Cardiovascular Risks Outweigh Benefits
The FDA approved anticoagulant Pradaxa in October 2010. The blood thinner soon became a blockbuster riding on manufacturer Boehringer Ingelheim’s claim that it was 35 percent more effective than its nearest competitor Warfarin. However, within weeks of its approval Pradaxa side effects topped the list of the FDA adverse reporting system. By 2011, the federal regulator had received more than 4,300 Pradaxa side effects complaints, including 542 reports of deaths, according to the Institute of Safe Medication Practices. Pradaxa side effects are linked to irreversible internal bleeding, heart strokes, hemorrhages, kidney dysfunction, and vascular problems that resulted in hundreds of deaths and injuries.
Pradaxa Internal Bleeding Risks
Pradaxa oral anticoagulant leads to inhibition of thrombin enzyme, which plays a key role in clotting blood in the body. As the drug effectively suppresses these enzymes, the human body lacks ability to prevent bleeding in time of need. In 2011, the FDA received 2,367 reports of Pradaxa-induced internal bleeding. Excessive bleeding, internal or external, aggravates and results in death. In case of other blood thinners, Vitamin K is used to check bleeding. However, there is also no medication available that can reverse the anticoagulant effects of Pradaxa.
The most common types of internal bleeding caused by Pradaxa side effects include bleeding from gums, frequent nose bleeding, and blood in urine and stool. Many patients also experience some symptoms, such as vomiting blood, coughing up blood, and unusual bleeding from bruises. According to the Randomized Evaluation of Long-Term Anti-coagulation Therapy test published in the New England Journal, Dabigatran, the main element of Pradaxa, enhances the risk of internal bleeding by 16 percent compared with Warfarin.
Pradaxa leads to severe dyspepsia and gastrointestinal bleeding. Tartaric acid in the drug reduces the pH level for better absorption. This results in stomach ache and mild to severe gastrointestinal bleeding. Patients already using non-steroidal anti-inflammatory medication are more likely to experience severe gastrointestinal problems when prescribed the drug. It has also been found that rectal bleeding caused by Pradaxa side effects puts patients with renal impairment at an enhanced risk of kidney failure.
According to the Journal of Neurosurgery, brain hemorrhage can be fatal for patients using Pradaxa. The drug badly alters the Thrombin Time and International Normalized Ratio or INR that impact the blood clotting activity in the event of hemorrhage. This enables bleeding to quickly spread and push brain injury patients into coma, as no antidote is available to reverse Pradaxa side effects. Intracranial bleeding due to Pradaxa side effects puts senior citizens at a greater risk of death with bumps on the forehead as the most visible symptom.
Pradaxa Cardiovascular Risks
The FDA has received many reports of myocardial infarction in patients taking Pradaxa. According to the European Society of Cardiology, the risk of dyspepsia and gastrointestinal bleeding caused by Pradaxa side effects puts patients at significantly increased danger of myocardial infarction and heart attacks. The findings were supported by a report published in the January 2012 issue of the American Heart Association Journal. A detailed study published in the American College of Cardiology Journal in February 2012 also highlighted that patients treated with Pradaxa therapy could be more susceptible to thromboembolic complications and strokes.
According to WebMD, one of the best online medical resources, Pradaxa is 30 percent more likely to cause stroke and cardiovascular side effects than other blood thinners on the market. Patients with mechanical heart valves, persistent deep vein thrombosis, and valvular diseases must refrain from using the drug, as it may endanger their lives. Researchers have also discovered that suddenly discontinuing or missing Pradaxa doses may cause considerable decrease in the anticoagulant characteristics of blood, which poses a greater risk of pulmonary embolism, thrombosis, and heart stroke. Pericardial and intra-articular bleedings are other common vascular side effects of the drug.
Pradaxa Risks Outweigh Benefits?
Though clinical trials have shown its superior efficacy for patients with atrial fibrillation, Pradaxa seems to be posing severe risk to patients. Pradaxa side effects render it impossible for blood to clot during hemorrhages. The rising number of Pradaxa lawsuits, complaints, and independent studies across the world pose serious questions on the safety of patients treated with the drug. Pradaxa side effect warnings and label changes following investigations by health regulators in Canada, Europe, Japan, New Zealand, and the United States indicate many areas where the dangers outweigh benefits, putting patients at the risk of health hazards.
About Pradaxa
Pradaxa, also known as Dabigatran Etexilate Mesylate, is an anti-coagulant drug commonly prescribed to prevent blood clots and strokes in patients with Atrial Fibrillation, a heart rhythm disorder. Because it is designed to prevent clots from forming, patients taking the drug may have a difficult time stopping bleeding from minor cuts. The drug can also effect bruising in the case of a fall, as it may cause internal bleeding (bruising) that continues to grow.
Benefit vs. Risk
Any anti-coagulant drug runs the risk of causing excessive bleeding, due to its effect on the blood. It is part of a delicate balancing act physicians and drug companies must handle: know when the benefits outweigh the risks. Before any drug is approved, drug companies must show that the benefits of taking the drug outweigh any potential side effects. Physicians must evaluate individual patients conditions and determine if their specific situation merits taking a drug with potential risk. In addition, drug companies and physicians must provide adequate warning of potential risks of any drug.
Specific Risks of Pradaxa
Reading the side effects of any drug can be an eye-opening experience as many medicines designed to benefit also have the potential of causing harm. As with any drug, Pradaxa has a list of possible side effects. What is alarming about Pradaxa is the growing number of reported cases of those “rare” side effects actually taking place. In December, 2011, the Food and Drug Administration (FDA) put the drug under review for safety concerns. Some of the specific concerns include:
- Bleeding Gums
- Vomiting or coughing up blood
- Blood in stool
- Blood in urine
- Severe bleeding
- Excessive menstrual bleeding
- Excessive nose bleeds
However, beyond the scope of these concerns, there are growing reports of side effects from Pradaxa that have been severe enough to require hospital care. Hemorrhage is a common complaint in these cases. In fact, the January issue of the Journal of Neurosurgery discussed the case of an 83 year old patient who died after using Pradaxa for four weeks. His death was caused by a Pradaxa-induced brain injury. The journal warned of the potential for more such cases. Brain hemorrhaging is not the only concern, gastrointestinal hemorrhage is another common complaint in Pradaxa cases.
Getting Help
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