Things To Know About Pradaxa Blood Thinner Drug Side Effect and Lawsuits
Pradaxa, generic name Dabigatran, is an oral anticoagulant drug manufactured by German pharmaceutical Boehringer Ingelheim. The blood thinner drug was introduced in October 2010, with the manufacturer claiming that it was superior to Warfarin, the then most sold drug in the same category. Pradaxa is prescribed to patients with atrial fibrillations or those with hip or knee replacement surgeries to prevent blood clots and strokes. Health regulators in the United States, Canada, Japan, and many European countries are investigating Pradaxa health risks reported in various studies and adverse event reporting systems. Litigations against the manufacturer are gaining momentum following the FDA discloser of investigations into health risks posed by the drug side effects in December 2011.
Studies on Pradaxa Side Effects and Efficacy
A drug safety report published by the Institute of Safe Medication Practices in January 2012 claimed that Pradaxa led to significant increase in hemorrhages, internal bleeding, and consequent death in users. Another study published in the American College of Cardiology Journal, a month later, warned that the drug increases the risk of thromboembolic complications, strokes, and internal bleeding by 16 percent compared to Warfarin. In March, the New England Journal of Medicine published a study highlighting hemorrhage, bleeding, cerebral, and cardiovascular risks associated with the drug in the absence of any effective reversal agent to contain Pradaxa side effects.
Pradaxa Complaints and FDA Warning
The FDA Adverse Event Reporting System received at least 932 Pradaxa side effect complaints, including 120 death reports and 505 reports on internal bleeding, in the first three months of 2011, according to the Institute for Safe Medication Practices. There was a significant increase in the number of Pradaxa complaints to the FDA in 2011 and these far exceeded any other blood thinner-related complaint. By the end of the year, 542 deaths and 3,781 complaints, including 2,367 bleedings, 644 heart attacks, and 291 cases of kidney impairment, had been reported.
In January 2012, the FDA concerned at the rising number of Pradaxa side effect complaints began an investigation into the adverse event reports. A month later, it ordered the manufacturer to update the label warnings on the drug and carry out a safety assessment based on post-marketing reports.
A press release issued by the British Prescription Medicines Code of Practice Authority on March 12, 2012, criticized Boehringer Ingelheim for calling Pradaxa a “wonder drug.” According to the regulatory body, the false efficacy claims by the manufacturer were against the British pharmaceutical industry code of practice. The agency also alleged that the manufacturer knowingly avoid warning people about Pradaxa bleeding side effects earlier.
Public health regulators in Japan, Canada, and many European nations have sought updated labels on the drug warning about potential health risks and advised health practitioners to screen patients for kidney problems prior to prescribing Pradaxa.
Pradaxa Side Effects and Injuries
According to post-marketing reports and independent investigations, Pradaxa side effects led to 260 deaths in the last two years, which is five times higher than reported by the drug manufacturer. The most common Pradaxa side effects include internal bleedings, such as bleeding from the gums, heavy menstrual bleeding, blood coughing, vomiting blood, and blood in urine. It also causes frequent nose bleeds and uncontrolled external bleeding worsening bruises.
Pradaxa lowers the gastric pH level when absorbed. This puts patients at the risk of dyspepsia and gastrointestinal bleeding. Seniors prescribed with the drug are likely to develop extracranial bleeding symptoms. Myocardial infarction associated with Pradaxa side effects result in mild to severe heart attacks and strokes. The conditions of patients with prior renal impairment are likely to deteriorate with the drug side effects. Post-marketing data has also highlighted persistent stomach pain in Pradaxa users.
Pradaxa Lawsuits
Pradaxa has been subject to litigations ever since the FDA ordered an investigation into post-marketing reports highlighting health risks posed by the drug side effects in December 2011. Manufacturer Boehringer Ingelheim has been facing an increasing number of Pradaxa lawsuits filed by US patients suffering from heart problems, internal bleedings, kidney impairment, and other serious side effects of the drug. The personal injury lawsuits have alleged that failure of the manufacturer to adequately research and warn patients of Pradaxa side effects made them to suffer from wrongful death, life-threatening hemorrhages, and other complications.
In August 2012, the MDL panel assigned 120 Pradaxa lawsuits filed in different federal courts to Judge David R. Herndon of Illinois southern district court for consolidated trial. On September 27, the court appointed 27 Pradaxa lawyers to the Plaintiffs’ Leadership Counsel, making it the largest ever in the US legal history. About 15 more Pradaxa lawsuits have been pending in California, Connecticut, and other state courts.
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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