Pradaxa Related Deaths

Pradaxa is an oral anticoagulent, or blood thinner, designed to prevent dangerous blood clots and stroke in certain high-risk patients. The drug is marketed as an alternative to warfarin that requires less monitoring and has fewer food and drug interactions. However, since Pradaxa was approved by the FDA in late 2010, thousands of serious adverse events have been reported in which Pradaxa was implicated as the primary cause, including over 600 alleged Pradaxa related deaths.

While the FDA has not issued a Pradaxa recall, stating that the benefits of stroke prevention outweigh the dangers from blood thinner side effects, Pradaxa victims and their families say that doctors and patients were never adequately warned about the risks of taking the drug, and doctors complain that the lack of an antidote means that patients who present with bleeding from Pradaxa often cannot be saved.

Fatal Pradaxa side effects

Pradaxa related deaths are usually caused by uncontrollable bleeding. Like other anti-coagulents, Pradaxa works by preventing the blood from clotting, which reduces the risk of stroke and other conditions caused by abnormal clotting. Unfortunately, blood thinners like Pradaxa also prevent the body from forming clots when they are needed, which can turn even a minor injury into a fatal bleeding event. Minor slips and falls, muscle strains, or even high-impact activities can cause uncontrolled internal bleeding, and Pradaxa is also thought to cause an increased risk of gastrointestinal bleeding. Uncontrolled blood loss over time can contribute to severe anemia, heart attack, and death.

The effects of some other blood thinners, like warfarin, can be reversed using a dose of Vitamin K. However, Pradaxa has no known antidote, and while Boehringer Ingelheim, makers of Pradaxa, recommend blood dialysis to remove Pradaxa, doctors say this is not a viable option for many of their patients and there is no clinical study to back up the efficacy of this method. Emergency room doctors report watching helplessly as patients fail to respond to treatment and die despite having access to emergency medical care.

The following are symptoms of potentially deadly blood thinner side effects.

If you experience any of the following while taking Pradaxa, seek emergency medical care immediately:

• Any unexpected, severe, or uncontrollable bleeding
• Bleeding that lasts a long time
• Unusual bleeding from the gums
• Frequent nose bleeding
• Unusual or unexpected bruising
• Bruises that get larger without a known cause
• Coughing up blood or blood clots
• Vomiting blood (vomit that looks like coffee grounds)
• Pink or brown urine
• Red or black stools (may look like tar)
• Unexpected pain, swelling, or joint pain
• Headaches and feeling dizzy or weak
• Heavier-than-normal menstrual or vaginal bleeding during your periods

Conditions that increase the risk of death

The FDA has issued a boxed warning, the most severe type of FDA warning, that patients who discontinue Pradaxa without moving to alternative blood thinner therapy are at an increased risk of developing blood clots and stroke. The FDA also warns that patients with prosthetic heart valves are at an increased risk of clots and bleeding from Pradaxa and are advised not to take Pradaxa at all.

The FDA also provides a list of risk factors that may increase the chance of severe or fatal bleeding events while on Pradaxa.

According to the FDA, patients with the following conditions face an increased risk of Pradaxa deaths:

• Advanced age (75 years old or older)
• Kidney problems
• Recent, or chronic, stomach or intestinal bleeding
• Stomach ulcer
• Taking other medicines that increase the risk of bleeding, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs), and other blood thinners
• Kidney impairment combined with certain other medications

FDA warnings about deaths linked with use of Pradaxa

In January 2012, the FDA label for Pradaxa was updated to include several new warnings based on post-marketing reports of serious adverse events and further clinical studies of the drug. The FDA issued a warning that patients with kidney problems may face an increased risk of blood thinner side effects because their kidneys may be unable to eliminate the drugs from the blood stream, effectively causing an overdose.

The FDA also warned doctors that Pradaxa’s anti-clotting effects cannot be reversed by Vitamin K, or any other known mechanism, in case of emergency.

Patients were warned at this time that discontinuing Pradaxa could cause an increased risk of stroke, which could cause severe brain damage and death, and that patients should talk to their doctors before discontinuing the drug. Patients were also warned to call their doctor immediately in case of any kind of fall or injury, especially a head injury.

In December 2012, the FDA updated their warning to include information from studies that showed that Pradaxa caused an increase in the risk of strokes, heart attacks, blood clots, and excessive bleeding in patients with prosthetic heart valves.

In April 2013, reports of thrombocytopenia, a condition in which platelet levels in the blood are lower than usual, were included in the Pradaxa label, and the warning about the danger of discontinuing Pradaxa was changed into a black box warning, indicating the seriousness of the danger and the potential number of deaths it could cause.

Pradaxa deaths spur lawsuits

Wrongful death suits from family members of Pradaxa victims are pouring into the federal court system. There are currently over 800 lawsuits alleging injury or death from Pradaxa pending in the U.S. District Court for the Southern District of Illinois, where they have been brought together for a process called multidistrict litigation, or MDL. Multidistrict litigation allows the quick and efficient resolution of large numbers of lawsuits making similar factual allegations.

Pradaxa lawyers representing the plaintiffs are currently engaged in the discovery process, in which the parties share information and attempt to reach settlement without trial, and presiding judge David R. Herndon has scheduled the first Pradaxa trial for August 11th, 2014, in case a settlement is not reached.

Among the lawsuits currently pending are the following Pradaxa wrongful death suits:

• Robert Lesnick died of brain bleeding less than two months after starting Pradaxa.
• Louise Newcomer died from gastrointestinal bleeding less than two months after taking Pradaxa.
• Charles Wagaman died from heart failure brought on by anemia caused by internal bleeding less than three months after starting Pradaxa.
• Carl Lutz died from a massive brain hemorrhage which occurred one month into his treatment with Pradaxa.
• Philip McNamar died from an aortic aneurysm less than ten days after being prescribed Pradaxa.
• Sidney Walter Denham died from gastrointestinal bleeding one week after beginning Pradaxa treatment.