Pradaxa is the brand name for dabigatran, a blood thinner prescribed to patients with atrial fibrillation. The drug is designed to prevent blood clots, stroke, and pulmonary embolism. Pradaxa was approved by the FDA in 2010, and is sold by the German drug company Boehringer Ingelheim.
Pradaxa has been linked with serious health risks, such as irreversible internal bleeding, heart attack, and even death.
The popular blood thinning drug Pradaxa has been prescribed to millions of patients with atrial fibrillation to prevent blood clots, stroke, and pulmonary embolism. However, this medication has been linked to dangerous health risks.
Common side effects from using Pradaxa:
Researchers have also linked Pradaxa with these serious conditions:
The drug was approved by the FDA in 2010. According to the FDA database, by 2012, over 17,000 people reported adverse side effects from using Pradaxa. In addition, 6,249 hospitalizations and 1,847 patient deaths were determined to be caused by Pradaxa use.
Problems with Pradaxa were reported immediately after the drug’s release to market. Within six months, the FDA received over 500 reports of internal bleeding or death among patients. Such reports are a rarity with the older drugs, Coumadin and Warfarin.
While all blood thinner medications. including Coumadin and Warfarin, pose the risk of causing internal bleeding, this condition can be effectively treated with “reversal agents.” There are no reversal agents for Pradaxa.
Soon after FDA approval, reports began to show that Pradaxa could cause serious and potentially irreversible internal bleeding. Within the first six months after the drug's release, the FDA received more than 500 reports of internal bleeding and deaths from conditions like brain hemorrhages.
The maker of Pradaxa faces liability because it did not warn patients that there is no reversal agent to stop internal bleeding, a severe side effect of the drug.
The rate of deaths among Pradaxa users was so high in 2011 that the FDA launched an investigation into the drug’s safety. That year, the agency received reports of 542 deaths among users, which led the death rate among all other drugs.
Most deaths related to Pradaxa use have involved internal bleeding in the brain, intestines, or kidneys, as well as heart attacks.
In January of 2013, the Institute for Safe Medication Practices again ranked anticoagulants like Pradaxa among the most dangerous of all outpatient drugs. In addition, it reviewed thousands of adverse event reports submitted to the FDA. SMP concluded that internal bleeding caused by Pradaxa is nearly five times more likely to result in death than with Warfarin.
Pradaxa has been prescribed to millions of patients in more than 70 countries. Soon after FDA approval, however, reports of serious health risks emerged, including uncontrolled internal bleeding.
Pradaxa has been linked to these serious conditions:
At this time, there is no official Pradaxa recall. However, a federal judge recently ruled that those affected by the drug's side effects, or family members who have lost a loved one, can proceed with lawsuits.
Experts still disagree about whether Pradaxa has higher risks for internal bleeding. The FDA recently advised that the drug is as safe as the more common prescribed the blood thinner Warfarin. However, the Institute for Safe Medication Practices has named Pradaxa one of the most dangerous drugs on the market and warned that patients suffering from internal bleeding after taking Pradaxa are nearly five times more likely to die from this condition than those with internal bleeding after taking Coumadin or Warfarin.
Additionally, a study from the University of Illinois at Chicago has suggested that the FDA's data may be flawed, and the risk for bleeding may be higher than the agency thought. Most recently, researchers in Denmark discovered that patients may be using Pradaxa improperly, and there may be higher risks of internal bleeding when switching from other blood thinners.
While all blood thinners can cause internal bleeding, most, like Coumadin or Warfarin, have "reversal agents" that can be used in the case of emergency. Doctors have reported that once Pradaxa causes bleeding, there is little they can do to stop it.
Pradaxa's manufacturer, Boehringer Ingelheim, faces liability for losses and damages to its consumers because it did not warn patients of these risks. Furthermore, the drug maker has a history of negligence.
Boehringer Ingelheim produces a large number of medications to treat abdominal pain, bladder disorders, COPD (chronic obstructive pulmonary disease), respiratory disease, acid reflux, ulcers, cardiovascular disease, Parkinson's disease, HIV, and thromboembolic disease. The company’s more widely known products include Pradaxa, Zantac, Spiriva, Flomax, Dulcolax, and Metacam.
The FDA has issued multiple serious safety violations against this company.
In 2011, the FDA shut down a drug manufacturing plant that was a Boehringer Ingelheim subsidiary. Inspectors noted that the Ohio facility contained mold, rusty tools, and a barrel of urine. The company then spent $300 million to appropriately upgrade the plant.
Most recently, Boehringer’s blockbuster drug Pradaxa has been the center of controversy. Pradaxa is linked to thousands of injuries and hundreds of deaths from uncontrollable internal bleeding.
Within weeks of the FDA’s approval of Pradaxa, further research by MedWatch showed the agency had received more reports of side effects from Pradaxa than 98 percent of any of the other drugs on the market. Complaints included internal bleeding in the brain, intestines, and kidneys, as well as heart attacks.
On December 7, 2011, the FDA launched an investigation into Pradaxa following reports of 3,781 side effects and 542 deaths, the highest number of cases reported for any drug that year.
In the United States, Boehringer Ingelheim faces nearly 1,000 lawsuits from patients affected by this medication. A federal judge recently blocked attempts by the company to dismiss victims’ cases. Due to the number of lawsuits expected by patients, the cases have been consolidated to a special federal multi-district litigation court in Illinois. The case is known as MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois.
For more information on Pradaxa, including the side effects, warnings, and legal action related to the drug, contact us today. A lawyer is available to speak with you 24 hours a day.