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Dallas Pradaxa Bleeding: Why is Pradaxa More Dangerous than Warfarin?

Recent reports of fatal Pradaxa bleeding events have come to the attention of the U.S. Food and Drug Administration (FDA). With as many as 260 Pradaxa deaths reported, many patients question why this new drug is more dangerous than Warfarin.

The Dangers of Pradaxa

Anticoagulants, used to prevent the clotting of blood, are used for the prevention of deep vein thrombosis, pulmonary embolism, heart attacks, stroke, and atrial fibrillation. Several types of anticoagulants fall into the classes of medications known as vitamin K antagonists and direct thrombin inhibitors. Warfarin is considered a vitamin K antagonist. Dabigatran, manufactured as Pradaxa, is a direct thrombin inhibitor.

Warfarin, a synthetic derivative of a mycotoxin anticoagulant, is primarily used to prevent blood clots from forming in blood vessels and traveling through the body. Warfarin can take anywhere from 24 to 36 hours after oral administration to achieve an anticoagulant effect. When taken with certain other medications, such as antibiotics, antidepressants, or food substances, it can cause adverse gastrointestinal side effects. The use of warfarin has been linked to life-threatening complications, including massive internal bleeding and intracranial hemorrhage.

Warfarin therapy requires periodic blood level monitoring to determine the blood clotting time relative to titrated doses. The antidote for warfarin is vitamin K. In cases of massive bleeding, rapid reversal can be achieved through an immediate infusion of a combination of prothrombin complex concentrate (PCC), fresh frozen plasma and vitamin K.

Pradaxa is the first direct thrombin inhibitor approved by the FDA since the late 1950s. Unlike warfarin, Pradaxa becomes effective immediately after oral administration, usually within two to three hours. Pradaxa has not been shown to have adverse effects when administered in combination with other medications or food substances. Unlike Warfarin, the use of Pradaxa does not necessitate blood monitoring.

Similar to warfarin, Pradaxa has been associated with potentially fatal adverse complications, the most serious being massive bleeding, including internal bleeding and intracranial hemorrhage. Unfortunately, the FDA approved Pradaxa without a medical antidote or reversal agent.

Urgent treatment for serious bleeding events caused by Pradaxa involves attempts to remove accumulated blood from internal body cavities through emergency dialysis and blood transfusions. Lacking an antidote, the prognosis for a patient suffering from massive bleeding due to Pradaxa is guarded.

Pradaxa Adverse Effects

Catastrophic bleeding events have been associated with warfarin and Pradaxa. Internal bleeding can cause heart failure, coma, and death. The effects of anticoagulants can cause blood vessels to leak and lose small amounts of blood, which begins accumulating in body cavities, compressing organs, and causing irreversible damage. Blood accumulation in the abdominal cavity can result in massive organ failure. Blood accumulation in the chest cavity can cause shock, respiratory failure and stroke.

An intracranial hemorrhage, also known as a cerebral hemorrhage, involves the rupture of blood vessels within the brain. Spontaneous bleeding into the brain can lead to coma and death. The mortality rate for intracranial hemorrhage is estimated at 40 percent. A patient who survives a massive intracranial hemorrhage may suffer from irreversible brain damage or may lapse into a permanent vegetative state.

Pradaxa Has No Known Antidote

Massive bleeding caused by anticoagulants is normally counteracted with an antidote or reversal agent. The immediate intravenous administration of mannitol, fresh frozen plasma, and vitamin K is typically supplemented with platelet transfusions. Surgical procedures may be performed to aspirate accumulated blood from body cavities. In the event of an intracranial hemorrhage, a catheter may be inserted into the brain in an attempt to repair or close leaking blood vessels.

Given the life-threatening risks associated with anticoagulant therapy, healthcare professionals should provide comprehensive information to patients before prescribing any anticoagulant medication. Periodic blood monitoring should be performed, regardless of the type of anticoagulant prescribed. Patients should contact their physicians immediately if they are experiencing any of the signs and symptoms that may be a precursor to a serious bleeding event:

  • unusual, sudden, or extensive bruises occurring for no known reason;

  • blood in the urine or stool;

  • frequent or unusual nosebleeds or bleeding from the gums;

  • excessive bleeding from minor cuts;

  • heavy menstrual flow or abnormal vaginal bleeding;

  • vomiting blood with the consistency of coffee grounds;

  • gastrointestinal pain or upset stomach associated with nausea and vomiting;

  • coughing or sneezing blood;

  • low blood pressure;

  • fatigue, lethargy, weakness; and

  • severe headaches associated with excessive vomiting.

New Anticoagulants Pose Bleeding Risk

Several anticoagulants are currently undergoing clinical trials and preliminary submission for FDA marketing approval. Merck Pharmaceuticals has recently completed clinical trials for its new anticoagulant, Vorapaxar, a direct thrombin inhibitor. It is currently being investigated as an experimental anticoagulant for the management of symptoms associated with coronary artery disease.

Clinical trials conducted by Merck were abruptly halted by the FDA due to the enrollment of patient participants with a history of stroke or heart conditions. The randomized, double-blind clinical study compared the effectiveness of Vorapaxar with standard anticoagulants and placebo. Reports from the preliminary stages of the clinical study revealed an alarmingly high risk of internal bleeding and intracranial hemorrhages. If the drug is approved by the FDA, experts anticipate its uses will be strictly restricted pending further studies to determine its safety and efficacy. Hopefully, an antidote will be identified prior to the release of Vorapaxar or any other new anticoagulants slated for clinical trials and approval.
In the opinion of many professionals, with whom we agree, Pradaxa is a bad drug which should not be prescribed. Patients who are currently on Pradaxa therapy should contact their healthcare provider to discuss whether a safer anticoagulant is a viable alternative.

For more information about Pradaxa bleeding, read our article “Blood Thinner Pradaxa Linked to Serious Bleeding Events.” Van Wey Law will be providing up-to-date information regarding Pradaxa lawsuits at www.vanweylaw.com. If you or a loved one suffered from Pradaxa bleeding, call Dallas drug injury attorney Kay Van Wey today at (214) 329-1350 or (800) 489-5082.


Kay Van Wey
Board Certified in Personal Injury Trial Law by the Texas Board of Legal Specialization

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