The exceptionally high number of Pradaxa side effect complaints within months of its market introduction and rising number of Pradaxa lawsuits have effectively blunted the “wonder drug” tag attached to it by manufacturer Boehringer Ingelheim. A number of studies have highlighted the high-rate thromboembolic problems and internal bleeding associated with the anticoagulant, while many have questioned the approval of Pradaxa given by the FDA in the absence of any proven antidote. Warnings by the FDA and European drug regulators have resulted in serious debate over the benefit versus risks of the drug.
Independent Studies Questioning Pradaxa Side Effects
In December 2011, the FDA had acknowledged to have initiated an investigation into post-marketing reports highlighting internal bleeding, brain hemorrhage, gastrointestinal bleeds, and death caused by Pradaxa side effects. The drug was introduced with tall claims about a year ago. The FDA also sought for label updates on the drug by manufacturer Boehringer Ingelheim with immediate effect to apprise users of the irreversible internal bleeding caused by Pradaxa side effects.
According to the Monitoring MedWatch Reports, a meta-analysis of the complaints through to the FDA adverse reporting system by the Institute for Safe Medication Practices and published in October 2011, there were 307 Pradaxa side effect complaints within the first three months of the introduction of the drug in the market, which was higher than any other type of medication monitored. MedWatch received 932 more complaints in the first quarter of 2011. This included at least 120 reports of death and over 500 reports of internal bleeding.
Pradaxa users also face an increased risk of heart strokes, thromboembolic complications, and number of vascular problems, according to the American College of Cardiology Journal. A study published on February 14th, 2012, warned that constant internal bleeding caused by Pradaxa side effects could lead to 16 percent higher incidence of thromboembolic complications or heart attacks when compared to other blood thinners. Researchers interviewed 290 atrial fibrillation patients using various blood thinners. A Reuters report in June 2012 also highlighted the rising concern among the healthcare professionals regarding Pradaxa cardiovascular risks.
In October 2011, Therapeutics medical journal published a study that casted serious questions on the approval of Pradaxa anticoagulant. According to researchers from the University of British Columbia , the clinical safety assessment was fundamentally wrong, biased, and full of errors, as it was based on a comparison between Pradaxa and Warfarin. A September 2012 report in the Journal of the American Medical Association also questioned fast tracking Pradaxa approval without considering unavailability of any antidote.
The Archives of Internal Medicine published a new Pradaxa study by European researchers in September 2012. A meta-analysis of seven studies, it claimed that the latest blood thinners, including Pradaxa, could provide any substantial benefit because of potential health hazards they became. The study took cognizance of more than 30,000 acute coronary syndrome patients treated with anticoagulants at placebo stages, clinical trials, and post-marketing phase. Researchers found that Pradaxa and similar blood thinners moderately reduced the risks of thrombosis and heart problems but tripled the risk of bleeding events.
The British regulatory agency, the Prescription Medicines Code of Practice Authority, PMCPA, accused Boehringer Ingelheim of violating the pharmaceutical code of conduct in December 2011. According to the PMCPA, the manufacturer misled consumers and doctors on Pradaxa safety information and failed to warn them adequately about bleeding hazard caused by it.
Pradaxa Side Effects: What To Do
In 2011, there were 3,781 Pradaxa side effect reports filed with the FDA. This was in additional to 542 reports of death caused by the drug. Internal bleedings, including GI bleeding and brain hemorrhage, topped the list with 2,367 cases, while 644 patients using the drug suffered from heart attacks. At least 291 people reportedly suffered kidney impairment after using the drug. The post-marketing reports also highlighted many patients suffering from adverse effects because of missed doses and unusual bleeding. Pradaxa users must contact doctors immediately if they are experiencing any symptoms, such as bleeding, gastrointestinal problems, or heart problems. A thorough checkup is also advised if they suffer from a sudden fall. Those already suffering from the drug side effects can contact lawyers to evaluate their case for filing a Pradaxa lawsuit.
Do I Have A Lawsuit
Warnings by health regulators worldwide and a number of independent studies affirm that Pradaxa is not a “wonder drug” as claimed by its manufacturers. Lack of any antidote to neutralize its anticoagulant effects puts patients treated with the drug at a greater risk of hemorrhage and death. If you or any of your relatives have suffered from Pradaxa side effects, you have every right to sue the drug maker and seek compensation for the injury, suffering, and medical treatment cost. Contact a Pradaxa lawyer to evaluate your case and file a drug injury lawsuit.
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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