Approved by the FDA in 2010, Pradaxa is a blood thinner or anticoagulant that is prescribed to patients with atrial fibrillation in order to lower their risk of stroke. It does this by making it difficult for blood clots to form. Unfortunately, taking any blood thinner increases the patient’s risk of experiencing uncontrolled bleeding – a logical side effect since blood thinner medications are anticoagulants.
Blood thinners that were on the market prior to Pradaxa (warfarin or Coumadin) required monthly blood tests to ensure that the dosage is correct. You also needed to be mindful of how much vitamin K was in your diet because it would interfere with how your medication worked. Pradaxa eliminated these needs and supposedly reduced the risk of uncontrolled bleeding for people with certain types of atrial fibrillation.
What Makes Pradaxa Dangerous?
While Pradaxa held a great deal of promise, problems became apparent almost immediately after Pradaxa hit the market. Patients who were taking Pradaxa began experiencing life-threatening conditions involving uncontrolled bleeding in the GI (gastrointestinal) system, the brain, and the kidneys. There may also be an increased risk of heart attack and other cardiac issues. In addition, the drug has also been linked to less serious side effects such as the following:
- Gastroesophageal reflux disease (GERD)
- Abdominal discomfort and pain
If you believe that Pradaxa has caused health problems for you, you should talk to an experienced Georgia Pradaxa attorney as soon as possible.
The Dangerous Effects of Pradaxa are Irreversible
The main problem with Pradaxa manifests itself when the patient suffers an injury that results in significant bleeding. Because they are on a blood thinner, the blood does not coagulate and clot like it normally would in order to close the wound. For other blood thinners, the doctor or hospital treating the patient can administer an antidote or reversal agent that will allow the blood to clot.
Unfortunately, the reversal agents that work with other blood thinners do not work with Pradaxa. Pradaxa has no known antidote or “cure”, a significant disadvantage to the drug. Patients who are taking Pradaxa may experience uncontrollable and life-threatening bleeding in situations such as the following:
- Ulcers or similar medical conditions
- Bodily injuries that occur in accidents such as lacerations or internal organ damage
- Spontaneous bleeding in the GI tract, brain, or kidneys
- Bleeding that can occur during surgery
The fact that you cannot reverse the effects of Pradaxa is what makes this drug so dangerous. A Georgia Pradaxa attorney can evaluate your case and determine whether you may be entitled to compensation.
Our Pradaxa Lawyer Outlines the Drug’s Risks to the Elderly
For patients on Pradaxa, uncontrolled bleeding can be caused by accidents as simple as a fall. As a result, the elderly are particularly at risk – they often have diminished balance and mobility, and have less fat and fragile blood vessels. As a result, even a minor, ground-level fall for someone who is older can result in uncontrolled bleeding that cannot be stopped due to the effects of Pradaxa. Injuries that result in internal bleeding or brain hemorrhages can be especially deadly.
Early Warning Signs Associated with Pradaxa
Within a month of its approval in 2010, it was reported that Pradaxa patients were experiencing more adverse reactions than 98% of the other drugs monitored by the FDA. A month after that, the FDA had received 120 reports of Pradaxa-related drugs. By 2011, Pradaxa had been linked to almost 4,000 injuries and more than 500 deaths in the United States, surpassing other drugs for risk of hemorrhaging, stroke, and acute kidney failure.
In 2012, medical researchers were reporting that Pradaxa users were 33% more likely to suffer a heart attack. In Europe, the manufacturer was ordered to provide clearer guidance to physicians for managing risks associated with the drug.
A Georgia Pradaxa attorney can evaluate your case, contact our firm today.
Why a Manufacturer May Be at Fault for Pradaxa’s Dangerous Side Effects
Experts believe that Pradaxa’s manufacturer, Boehringer Ingelheim, rushed through the testing process when developing the drug in order to beat other manufacturers to the market. Along the way, Boehringer Ingelheim ignored obvious risks and endangered the health and safety of consumers who would later take the drug. In addition, those who have pursued claims allege that the manufacturer failed to warn the FDA, doctors, and patients of the risks of uncontrolled bleeding as well as the increased risk of a heart attack.