Pradaxa Side Effect Injury Lawsuits
Anticoagulant Pradaxa accounted for the highest number of prescription drug side effect injuries reported in 2011, according to the QuarterWatch report of the Institute for Safe Medication Practices. The FDA received 3,781 Pradaxa adverse event reports, including 542 deaths, 2,367 hemorrhages, 644 heart attacks, 291 kidney impairments, and 15 cases of liver failure, that year, which was almost three times higher than side effect injuries associated with Coumadin, the most reported Warfarin blood thinner.
A meta-analysis of MedWatch adverse event reporting system in 2012 highlighted that internal bleeding caused by Pradaxa side effects could pose a five-fold higher risk of death than any Warfarin-based anticoagulant. Pradaxa led to 956 side effect injury complaints, including 178 deaths, in the second quarter of 2012, which was far higher than 214 adverse events and 14 deaths linked to other Warfarin blood thinners reported during the same period.
Pradaxa Fact File
|Generic Name: Dabigatran|
|Pradaxa Use: Anticoagulant, blood thinner;|
|Manufacturer: Boehringer Ingelheim, based in Ingelheim am Rhein, Germany|
|Year of Approval: October 2010|
|MedWatch Complaints: 817 directly from consumers and doctors and 2,964 from manufacturers|
|Pradaxa Side Effects: Internal hemorrhages, heart attacks, renal impairments, Stomach pain, and liver failure; More than 500 deaths in the last two years|
|Pradaxa Lawsuits: More than 200 product liability lawsuits filed in various federal courts and counting|
History of Pradaxa
The FDA approved anticoagulant Pradaxa in October 2010 to prevent blood clotting in patients who undergo hip or knee replacement surgeries. The blood thinner produced by German drug maker Boehringer Ingelheim contains thrombin inhibitor Dabigatran, which forestalls the blood from coagulating. The drug is also used to treat patients suffering from non-valvular atrial fibrillation and at the risk of heart stroke.
Manufacturer Boehringer Ingelheim claims that Pradaxa is better than other Warfarin-based blood thinners used by patients and that there is no need for frequent tests to keep tab on blood international normalized ratio (INR). However, researchers have found that Pradaxa does not offer any significant benefit for patients already treated with Warfarin and those who have good INR. Rather, the drug has added health risks, such as hypertension, congestive heart failure, liver damage, and kidney disorders, which neutralize its benefits. There is no medication at present that can reverse the effects of Pradaxa in the case of internal bleeding, and this puts patients at the risk of death. In the last two years, Pradaxa caused over 500 deaths and more than 3,000 severe and debilitating injuries, making it one of the most unsafe drugs in the United States.
Pradaxa Side Effects
Boehringer Ingelheim received at least 350 post-marketing reports of fatal Pradaxa side effect injuries within the first three months of its introduction. The subsequent rise in adverse events led to a chorus of complaints across the medical community, criticizing approval of a drug without any proven antidote to reverse its impact. Major Pradaxa side effect injuries reported during clinical trials, post-marketing studies by research scholars and on the FDA MedWatch program include:
- Internal Bleeding: Hemorrhage caused by Pradaxa side effects is irreversible in the absence of any medication to reverse the impact of the blood thinner. It has been linked to intracranial, intraspinal, and retroperitoneal bleeding. Persistent bleeding from nose, mouth, vagina, or rectum once started after the drug taken could prove fatal for patients. Women taking the drug may likely to have heavy menstrual bleeding. Intracranial hemorrhage can cause cerebral stroke and death of patients. The drug can also be fatal for patients requiring prosthetic heart valves.
- Cardiovascular Problems: A meta-analysis of MEDLINE database followed by a Cleveland Clinic study highlighted in 2012 that Pradaxa could increase the risk of heart attacks by 33 percent compared to Warfarin blood thinners. Patients treated with the drug experienced severe chest pain, breathing problem, congestive heart failure, myocardial infarctions, and strokes. More than 600 people had medium to near fatal heart attacks following the drug intake.
- Liver Injury: In 2011, the FDA received at least 15 complaints blaming Pradaxa for liver failure in patients. Dabigatran is known to contraindicate liver problems leading to hepatic conditions.
- Kidney Damage: Patients with renal impairments could face serious troubles, as the drug contraindicated kidney problems.
- Gastrointestinal Injuries: Pradaxa side effects may cause abdominal pain, gastric hemorrhage, ulcer, and erosive gastritis.
- Short-Term Side Effects: The drug consumption leads to face and throat swelling, respiration difficulty, weakness, blood in urine and stool, coughing up, joint pain, stomach pain, skin rash, nausea, and diarrhea.
Pradaxa Side Effects Warnings
- In December 19, 2012, the FDA issued a public health alert warning against use of Pradaxa by patients with mechanical heart valves.
- In May 25, 2012, the European Medicines Agency recommended close surveillance of all patients treated with Pradaxa for the risk of internal bleeding and renal impairment.
- In February 2012, the FDA asked Boehringer Ingelheim to update warning labels on Pradaxa to include the risk of death caused by internal bleeding and cardiovascular disorders.
- In December 7, 2011, the FDA ordered an investigation into the health risks caused by Pradaxa following large number of complaints citing fatal side effect injuries on its MedWatch adverse event reporting system.
- In November 3, 2011, Australia’s Therapeutic Goods Administration warned about 50 percent higher risk of hemorrhage associated with Pradaxa.
- In August 12, 2011, the Japanese Government mandated boxed warning for Pradaxa highlighting the risk of hemorrhage in users.
Pradaxa Research Studies
- A report published by the Medco Health Solutions in 2012 claimed that Pradaxa could lead to a three-fold rise in heart stroke and hemorrhage risk compared to Warfarin blood thinners.
- The American College of Cardiology Journal reported in February 2012 that Pradaxa had significant high risk of internal bleeding and thromboembolic side effects than other anticoagulants in the market. The study based on analysis of 30,470 patients listed on the National Institute of Health database found that the hemorrhage risk associated with Pradaxa is 16 percent high compared to less than 6 percent risk posed by other blood thinners.
- In March 2012, another report on the Archives of Internal Medicine warned that Pradaxa blood thinner could increase the risk of cardiovascular problems by 33 percent. The study carried on by the Cleveland Clinic listed a number of symptoms associated with heart attack as the drug side effects. Six months later, another report based on findings of European scholars claimed that significant risk of hemorrhage outweighs benefits of Pradaxa.
- The New England Journal of Medicine published a research study in March 2012, which claimed that lack of reversal agent make Pradaxa side effect injuries more serious and fatal.
- The 2012 second quarter report published by the QuarterWatch surveillance program of the Institute for Safe Medication Practices found that bleeding side effects of Pradaxa is five-time more likely to end in fatalities than Warfarin-induced hemorrhage risk.
More than 200 Pradaxa product liability lawsuits have been filed in various US federal courts citing serious and fatal injuries caused by the drug. On March 7, 2012, a woman from Tennessee filed the first Pradaxa lawsuit in a federal court citing product liability, side effect injuries, and failure of the manufacturer to warn users adequately about the potential drug side effects. The plaintiff’s mother died following severe gastrointestinal bleeding after treated with Pradaxa blood thinner for two months. This was followed by a spate of product liability lawsuits against Boehringer Ingelheim in Kentucky, Oklahoma, Tennessee, and Louisiana and the number crossed 100 by August 2012. A lawsuit seeking class action status has also been filed in Illinois.
On July 25, 2012, Judge David R. Herndon of Illinois south federal court rejected plea by Boehringer Ingelheim to dismiss Pradaxa lawsuits on the ground that it had issued prior warnings. The judge ruled that warning by the manufacturer about the potential fatal internal bleeding associated with the drug was not enough to educate people and prevail over the allegations by the plaintiffs. The MDL panel ordered for pre-trial consolidation of more than 120 Pradaxa lawsuits at the Illinois south federal court in August 2012. The first trial of federal Pradaxa lawsuits is expected to commence on August 11, 2014 while the first state court hearing is scheduled for September 22, 2014.