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Manufacture Adds Black Box Warning as Pradaxa Lawsuits Surge
Pradaxa manufacturer Boehringer Ingelheim has amended labels on the anticoagulant to add more warnings on its side effects. The latest change incorporates a black box warning for potential risk of stroke while the number of Pradaxa lawsuits claiming internal bleeding injuries continues to surge. The FDA has received over 5,000 reports of Pradaxa side effects in the last two years. While more than 500 persons have died due to irreversible hemorrhage linked to Pradaxa blood thinner, at least 2,300 have suffered serious internal bleeding injuries. There were also reports of stroke, kidney dysfunction, gastrointestinal bleeding, thromboembolic problems, and vascular complications.
Pradaxa Black Box Warning
The new Pradaxa side effect warning disclosed by Boehringer Ingelheim on April 30, 2013 through a press release informed users about the potential risk of stroke. It proposed to add a black box warning, the highest level of advice for side effects, cautioning users against discontinuing the blood thinner without approval of their doctors. The manufacturer also warned of thrombocytopenia or risk of abnormally low number of blood platelets caused by Pradaxa.
The anticoagulant administered orally prevents blood clots and strokes in patients diagnosed with atrial fibrillation. Pradaxa inhibits thrombin enzyme, the most important catalyst for blood clotting. According to the latest boxed warning, sudden discontinuation of the drug may result in fast thrombin enzyme action putting patients at the risk of stroke. Similarly, the lack of clotting factors enhances the risk of low blood platelet level.
Other Pradaxa Side Effect Warning
Pradaxa topped the list of drugs most reported for adverse events in 2011, says the 2012 data released by the Institute for Safe Medication Practices. According to the QuarterWatch report, the blood thinner led the table with 3,781 report adverse events, which included 542 fatalities. While 644 users had heart attacks, there were at least 644 reports of kidney problems. About 15 users suffered liver damage. The total number of hemorrhage incidents stood at 2,367. In the first quarter of 2012, there were 178 deaths linked to Pradaxa side effects.
The Journal of Neurosurgery has warned patients of fatal brain hemorrhage risk linked to using Pradaxa. According to it, the drug leads to significant changes in INR and pro-thrombin time, which enhances the intracranial bleeding and put those with brain injury at the risk of coma. The New England Journal of Medicine in a study published in March 2012 cautioned Pradaxa users of irreversible bleeding, as there is no antidote of the blood thinner available in the market.
The American College of Cardiology Journal published findings of a research in February 2012 that linked increase of thromboembolic complications and bleeding events in patients to Pradaxa side effects. The study was based on the medical observation of 290 patients treated with the blood thinner. Six months later, a study in the Archives of Internal Medicine warned that the blood thinner could increase the risk of bleeding by three times. Researchers looked into findings of seven studies covering about 30,000 patients.
Pradaxa Lawsuit
Thousands of Pradaxa lawsuits have been filed in various federal and state courts in the United States. The primary claim of product liability by plaintiffs stems from the failure of manufacturer Boehringer Ingelheim to warn about irreversible bleeding risk associated with the blood thinner. Litigations question the aptness of introducing a drug in the market that does not have any reversal or controlling medication. Serious Pardaxa bleeding side effects often leads to fatalities, as there is no therapy in sight to stop the adverse effects.
In July 2013, Judge David R. Herndon of Illinois Southern District Court dismissed a petition for Pradaxa class action, but ruled in favor of individual claims to proceed. About 1,100 Pradaxa lawsuits are centralized in his court under the multidistrict litigation provision. The judge rejected the argument by Boehringer Ingelheim to dismiss Pradaxa lawsuits and permitted individual claims to go forward under necessary product liability laws.
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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