Did you or a loved one suffer from a serious bleeding event while taking Pradaxa?
In 2010, Boehringer Ingelheim Pharmaceuticals released the blockbuster blood thinner Pradaxa that was seen as one of the biggest pharmaceutical advances of its time. Shortly after, however, reports of serious injury and allegations of wrongful deaths ensued.
Despite more than 1,000 deaths having been reported as a result of Pradaxa use, the drug is still widely used while many continue to question its safety.
If you or a loved one suffered from life-threatening bleeding while taking Pradaxa, you may qualify to file a Pradaxa lawsuit. Contact the attorneys at McDonald Worley today for a FREE case evaluation.
WHAT IS PRADAXA?
Pradaxa (dabigatran) was the first of several new blood thinners known as new generation oral anticoagulants, or NOACs. These blo were designed as an alternative medication to warfarin, the industry standard blood thinner for the previous 60 years.
Pradaxa was initially seen as a huge improvement over warfarin due to its apparent ease of use. Unlike warfarin, Pradaxa did not require continual blood monitoring of patients, and standardized dosing was available. Also, patients taking Pradaxa did not have to conform to a specific diet while they were taking the drug, in contrast to warfarin users who had to avoid certain foods that could potentially interfere with the drug’s effectiveness.
Pradaxa was initially approved to treat patients who suffered from atrial fibrillation. Atrial fibrillation is an abnormal heart condition that causes the chambers of the heart to contract at different times, causing the upper chambers of the heart to be out of sync with the rhythm of the heart chambers below. This abnormal heartbeat can cause blood to pool and lead to the development of clots.
Later, the drug was approved to treat and prevent deep vein thrombosis, a condition where blood clots develop in the deep veins of the lower extremities. These clots can travel to the heart and lungs and cause heart attacks, strokes, and other major problems.
Pradaxa was also approved to treat a related condition, pulmonary embolism. A pulmonary embolism results when blood clots formed in the lower extremities travel to the lung. A blood clot in the lungs will restrict blood flow and decrease oxygen levels. Large blood clots, as well as multiple blood clots found in the lungs, can prove to be fatal.
It wasn’t long until Pradaxa became a top-selling drug due to its apparent advantages over warfarin. But not long after that, reports of serious injuries linked to the drug also began flowing in, and its popularity decreased. Other new-generation oral anticoagulant medications began gaining ground after the safety of Pradaxa started being questioned.
PRADAXA SIDE EFFECTS
There are several Pradaxa side effects, but most are mild and may diminish or disappear after the body gets used to the drug. These include easy bruising or minor bleeding events, such as nosebleeds or longer bleeding from small cuts, stomach pain or indigestion, heartburn, nausea, or itching. They are typically mild enough that they do not severely affect a patient.
The most severe side effect linked with Pradaxa use is the increased risk of uncontrollable bleeding. This risk is common with any anticoagulant drug, including warfarin. The bleeding side effect is directly linked to the way the drug works. The drug blocks an enzyme responsible for clotting, and therefore reduces the chance that clots will form.
In order to prevent issues like deep vein thrombosis, pulmonary embolism and blood clots due to abnormal heart rhythm, it is essential that the blood is thinned so it does not produce clots. However, there are situations where blood clots actually save lives. When a person has internal bleeding, the body naturally forms a clot to stop the bleeding to begin healing the body.
If internal bleeding develops for a person taking Pradaxa, the body cannot make the necessary clot to stop the bleeding, and the uncontrollable bleeding becomes an emergency situation. Patients experiencing uncontrollable bleeding must be rushed to the hospital for stabilization. This is the point where Pradaxa showed a huge disadvantage when compared with warfarin, during its first five years on the market.
Unlike warfarin, there was no antidote to reverse the blood thinning effects of Pradaxa to restore the body’s natural clotting abilities. Emergency room personnel had to just “wait it out” as Pradaxa processed through a patient’s system and hoped that the bleeding did not progress to a level that was severe or fatal.
When patients on warfarin developed an uncontrollable bleed, the hospital staff could administer fresh frozen plasma or intravenous vitamin K to reverse the anti-clotting mechanisms of warfarin. According to statements made in lawsuits, it was not widely known among physicians and patients that there wasn’t a reversal agent available for Pradaxa users from the time it was released until about five years later.
In the fall of 2015, Boehringer Ingelheim introduced Praxbind, a reversal agent to be used for patients suffering uncontrollable bleeding on Pradaxa. Before then, however, critics claimed that it was irresponsible of the manufacturer to have released a drug that did not have an antidote like its predecessor, warfarin.
Pradaxa Reaches Large Settlement in 2014, Drug Maker Denies Wrongdoing
Thousands of patients began to file lawsuits against Pradaxa’s manufacturer alleging that they had developed severe bleeding complications as a result of using the medication. The most common types of injuries were gastrointestinal bleeds and brain bleeds. These lawsuits sought to hold the manufacturer accountable and to recover damages related to injuries sustained after using the drug.
In 2014, Pradaxa’s manufacturer agreed to a $650 million settlement to resolve claims raised in more than 4,000 lawsuits that were pending at the time. However, Boehringer Ingelheim maintained that it had not engaged in any wrongdoing but agreed to settle the claims to avoid further costs and uncertainty of continuing with the litigation.
Taking Legal Action over Pradaxa Complications is Still Possible
Many Pradaxa lawsuits were filed after 2014 and continue to be filed as patients and their loved ones discover more information surrounding the safety issues at hand prior to the release of the Pradaxa antidote.
If you or a loved one was injured after taking Pradaxa, you may be eligible to take legal action against the manufacturer to recover economic and noneconomic damages suffered. An experienced Pradaxa attorney can provide you with a free, no-obligation case review and can discuss your options for pursuing litigation.