Pradaxa Side Effects Put Patients at Increased Health Risk
Pradaxa side effects have been linked to over 542 deaths caused by excessive internal bleeding and at least 3,781 health-related complaints reported to the FDA’s adverse reporting system over the last two years. The blood thinner, claimed to be more effective compared to similar medications, has surprisingly generated more consumer complaints than any other drug in the US market within a short span of its introduction. Manufacturer Boehringer Ingelheim has been facing hundreds of lawsuits accusing the drug maker of failure to inform users of serious Pradaxa side effects, including cerebral bleeding, hemorrhagic stroke, pericardial bleeding, and renal impairment.
Important Pradaxa side effects
- Internal Bleeding
Life-threatening internal bleeding is the most common of Pradaxa side effects. People prescribed the drug are likely to suffer from coughing up or vomiting blood, frequent nose bleeding, unusual bruising, bleeding from gums, and blood in urine and stool. The external bleeding can also aggravate in patients taking the drug. Intracranial and extracranial bleeding caused by Pradaxa puts seniors at the risk of death. It inhibits thrombin enzyme, responsible for blood clotting, and prevents blood from clot, leading to death in some cases. There is no medicine available to stop hemorrhage caused by Pradaxa side effects.
- Gastrointestinal Bleeding
According to a research, one in every seven Pradaxa users face the risk of gastrointestinal bleeding. While it can be serious in case of 3.3 percent users, 1.5 percent users face the risk of fatal internal bleeding. Tartaric acid in Pradaxa brings down the gastric pH level, which results in dyspepsia or uncomfortable feeling in stomach. Persistent dyspepsia increases the risk of gastrointestinal bleeding. Those already taking non-steroidal anti-inflammatory drugs also face enhanced risk of GI bleeding on administration of Pradaxa.
- Heart Stroke
A meta-analysis published by the American Heart Association in January 2012 confirmed the enhanced risk of heart attacks associated with Pradaxa side effects. The drug increases the risk of myocardial infarction, which results in mild to severe heart strokes. A research report in the American College of Cardiology Journal (Feb, 2012) found that Pradaxa raises thromboembolic complications, strokes, and bleeding risks than other blood thinners. According to WebMD, the risk is as high as 35 percent compared to Warfarin, another popular blood thinner. Intra-articular bleeding and pericardial bleeding are among the most reported vascular disorders caused by the drug. There were at least 644 cases of heart attacks caused by Pradaxa side effects in 2011.
- Brain Hemorrhage
A report published in the Journal of Neurosurgery in March 2012 highlighted death of an 83-year-old man using Pradaxa from brain hemorrhage. He was hospitalized after a minor fall and died within 24 hour, as doctors failed to check bleeding in the brain. He was on Pradaxa therapy for the last one month after suffering from atrial fibrillation. The blood thinner drug left him with far less International Normalized Ratio and Thrombin Time, effectively preventing blood clotting and worsening hemorrhage.
- Kidney Impairment
Pradaxa side effects cause renal impairment and aggravate existing kidney problems. The drug poses serious problems for elderly patients suffering from kidney ailments and results in kidney failure. Persistent rectal bleeding aggravates the problem and as the kidney is unable to process the drug, its rising level puts patients at a greater risk of complications.
The post-marketing reports have also highlighted neurological disorders, such as headache, dizziness, and exhaustion, in patients taking Pradaxa. Bleeding from the gums, swelling of ankles and joints, nose bleeds, and weakness of hands and feet are also common in patients taking the drug. There is no drug that can check the anti-coagulant effects of Pradaxa.
FDA Warnings
In December 2011, the FDA began an investigation into Pradaxa side effects following reports of a high number of deaths and health problems associated with the drug. A month later, it ordered manufacturer Boehringer to update drug label warning to inform consumers about bleeding risks and to start a comprehensive safety review of the drug. Similar actions were soon taken by drug regulators in Canada, Japan, New Zealand, and many European countries. In some European countries, health regulators have advised doctors to screen kidney patients before prescribing them the drug. Research studies and complaints highlighting Pradaxa side effects are pouring and lawsuits by those suffering from its adverse effects continue to rise.
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
If you feel helpless to take your case against a large pharmaceutical company, our skilled lawyers are ready to help. We have been actively monitoring developments in Pradaxa related events and are prepared to assist you. We understand your concerns and will work on your behalf to get the legal recourse you deserve.
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