Pradaxa is a drug used to reduce the risk of blood clots and stroke due to atrial fibrillation that are not caused by heart valve problems. It was introduced in 2010 as an alternative to the popular anticoagulant drug warfarin. Warfarin is known to be extremely effective, but it requires a great deal of monitoring. Patients must test their blood on a daily basis, and adjust their dosage as needed. Dietary changes are also needed when using warfarin. None of these requirements is an issue with Pradaxa, but the drug does feature side effects that are not a concern for warfarin users.
Research has shown that Pradaxa is more effective for reducing the risk of stroke than warfarin. It is more expensive than warfarin, but considered a better option by doctors and patients because it requires no dietary changes or daily monitoring.
Warfarin works by affecting vitamin K activity in the blood, while Pradaxa reduces the actions of thrombin, a clotting protein in the blood. Research shows this lessens the risk of blood clots even more than warfarin.
Like many drugs, Pradaxa is given to patients for reasons not originally intended for use. In addition to prescribing the drug to prevent blood clots not caused by heart valve problems, Pradaxa is also given by doctors to patients to prevent venous thromboembolism, a blood clot that occurs deep in a vein that travels to the lung, resulting in a pulmonary embolism. This can be especially problematic when a person is unable to get regular physical activity, as the case may be after surgery while a patient heals. This is not yet an FDA-approved use of the drug.
Common Side Effects of Pradaxa
Pradaxa is known to trigger a number of minor side effects, many of which resolve after a person’s body has adjusted to the drug. These side effects include:
- Stomach pain
Users of Pradaxa might also experience increased bleeding or bruising from minor injuries.
Serious Side Effects of Pradaxa
In addition to the minor side effects, especially those related to bleeding, Pradaxa puts patients at risk because of its blood thinning capabilities. Patients with intestinal or stomach bleeding, or kidney problems, or those who are older patients or undergoing certain medical procedures and surgery must be especially careful to monitor bleeding and ensure Pradaxa does not trigger a serious medical emergency.
Pradaxa features a variety of additional serious side effects that include:
- Uncontrollable or unusual bleeding
- Liver failure
- Heart attack
- Brain hemorrhage
- Central nervous system hemorrhages
- Cough that includes blood
- Brown or pink urine
- Vomit that resembles coffee grounds
- Weakness or dizziness
Pradaxa was mentioned in the FDA’s adverse reporting database in 2011 more than any other drug with 817 mentions. The drug has been linked to more than 3700 adverse event reports filed by health professionals, manufacturers, and other databases.
An additional study of Pradaxa showed a 33 percent increase compared to warfarin users in the risk for heart disease and heart attack.
The drug has also been linked to more than 500 deaths caused by uncontrollable bleeding and hemorrhaging. This has been the case for other blood thinning warfarin alternatives, as well. However, a November 2012 report by the FDA concluded the risks associated with Pradaxa for uncontrolled are no more serious than they are with warfarin.
The report stated Pradaxa users do not face a greater risk for suffering bleeding events than warfarin users, but are at a greater risk than warfarin users because there is no antidote. Bleeding events caused by warfarin can be stopped with a vitamin K antidote, while no antidote exists to stop bleeding for Pradaxa users.
Pradaxa Users Take Legal Action
As a result of more than 4000 claims related to uncontrollable bleeding events and Pradaxa use, many of which resulted in death, the company paid $650 million to settle claims in 2014. The company continues to claim its product is safe and its benefits outweigh the risks associated with it.
Our goal is to ensure Pradaxa users and anyone using a blood thinning medication understands the risks associated with the drugs. It’s important patients be informed and receive factual information needed to make the best decisions for their health. If you or a loved one suffered a severe bleeding event or other injuries after using Pradaxa, compensation might be available.