Pradaxa Lawsuit: Complications And Claim
Pradaxa is an anticoagulant manufactured by the German pharmaceutical company Boehringer Ingelheim. It was approved by the FDA in 2010 as a prevention of strokes, but by 2014 there were several death reports linked to the intake of the drug and the company settled 4,000 lawsuits for $650 million.
Pradaxa (dabigatran) helps to prevent platelets in your blood from sticking together and forming a blood clot. Pradaxa is used to reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation. Pradaxa is also used to treat blood clots in the veins of your legs (deep vein thrombosis, or DVT) or lungs (pulmonary embolism, or PE) and reduce the risk of them occurring again.
The drug, however, has caused several complications like gastrointestinal bleeding, kidney bleeding, internal bleeding, pain, brain hemorrhage, hospitalization, suffering and even death. A total of 4,000 pradaxa blood thinner lawsuits have been claimed pointing out the symptoms caused by the drug including several hundred deaths.
Pradaxa or dabigatran is an anticoagulant or blood thinner that is prescribed to reduce the risk of stroke and blood clots in people with atrial fibrillation. The medicine was approved by the FDA in October 2010. The principal side effects listed at the time of approval were dyspepsia (indigestion) and gastritis (inflammation of the lining of the stomach).
In April 2013, the FDA asked Pradaxa to include a “black box warning” that read a warning “Discontinuing Pradaxa in patients without adequate continuous anticoagulation increases risk of stroke”. Later, the label added “thrombocytopenia (abnormally low number of platelets in the blood)” and “Esophageal ulcers” as two more adverse reactions reported by Pradaxa users.
The FDA’s many required revisions to the Pradaxa label implies that the drug’s original labeling failed to provide adequate warning to patients and physicians about Pradaxa’s many serious and life-threatening complications.
Pradaxa is reported to have caused very serious blood clot around the patient’s spinal cord if he has undergone a spinal tap or receive spinal anesthesia (epidural). The risk goes up if the user has a genetic spinal defect, if he has a spinal catheter in place, if he has a history of spinal surgery or repeated spinal taps or if the user is taking other drugs that might affect blood clotting.
The blood clotting might lead to long-term or permanent paralysis. Bleeding is the serious side effect of Pradaxa caused by dabigatran, its most active ingredient. Major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes.
Pradaxa has been linked to thousands of adverse events and over 1,000 fatalities, for which Boehringer Ingelheim has already paid $650 million.
Since its FDA approval in 2010, Pradaxa has been linked to thousands of adverse events and over 1,000 fatalities. These injuries and fatalities resulted in 4,000 lawsuits by August 2012 as filed by Pradaxa patients and consolidated into a multidistrict litigation (MDL).
In May 2014, Boehringer Ingelheim agreed to pay $650 million to settle all of its 4,000 lawsuits. But it wasn’t until October 2015 that the FDA approved an antibody called Praxbind (idarucizumab), which has been shown to reverse the anticoagulation effects of Pradaxa.
That means that for nearly a year and a half, Pradaxa patients did not recover any damages from the drug maker but still had no antidote for the drug’s hemorrhages.
If you or any of the ones you know have suffered from any serious complications and if you didn’t file the pradaxa blood thinner lawsuit during the 2014 settlement, and you took Pradaxa before the antinode hit the market, you are entitled to compensation for the damages caused.