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Pradaxa is an oral medication that comes in capsule form. Commonly known as a blood thinner or anticoagulant, the drug carries the generic name of dabigatran. The drug, manufactured by Boehringer Ingelheim Pharmaceuticals, belongs to the drug class thrombin inhibitors – unlike its predecessor, warfarin.
Pradaxa was approved by the United States Food and Drug Administration in October 2010, and the drug helps in preventing strokes and blood clots in patients suffering from atrial fibrillation. In addition, dabigatran also helps treat blood clots from forming in the veins of either the leg (deep vein thrombosis) or the lungs (pulmonary embolism).
Warfarin works by decreasing the activity of vitamin K (an essential element in blood clotting), while dabigatran works by inhibiting the action of thrombin, which is a blood clotting protein. Although the two anticoagulants deliver the same results, Pradaxa does not have an antidote, unlike warfarin.
Dabigatran is similar to its counterpart successor, Xarelto, another anticoagulant. Both have the same adverse side effects, with the most reported one as irreversible bleeding. The two drugs are currently facing a growing number of lawsuits from patients who have experienced the adverse and life threatening side effects of the drug.
Plaintiffs have filed personal injury and product liability lawsuits against Boehringer Ingelheim Pharmaceuticals for failure to warn of the adverse side effects from the use of the drug, in addition to failing to warn about the absence of an antidote.
Over 2,000 cases have also been consolidated into a multidistrict litigation in the U.S. District Court for the Southern District of Illinois. The cases were to be presided over by U.S. District Court Judge David Herndon.
However, in May 2014, Boehringer Ingelheim settled over 4,000 lawsuits for $650 million. In spite of the settlement, the drug manufacturer has denied the validity of the plaintiffs’ claims and continues to stand by the effectivity of the drug.
What is Pradaxa?
Pradaxa is a prescription oral medication, commonly known as a blood thinner. Carrying the generic name dabigatran, the anticoagulant prevents the blood platelets from clotting.
Dabigatran is prescribed to:
- Reduce the risk of stroke and blood clots in patients who have atrial fibrillation
- Treat blood clots in the veins of the legs, (also known as deep vein thrombosis), or lungs (also called a pulmonary embolism) and reduce the risk of these conditions from recurring.
The drug — manufactured by Boehringer Ingelheim Pharmaceuticals – belongs to a drug class called thrombin inhibitors and was considered a better alternative than its predecessor, warfarin, because of its ability to limit stokes.
Approved by the United States Food and Drug Administration in October 2010, the drug aids in preventing strokes, in addition to being a lower maintenance blood thinner as compared to warfarin. Warfarin requires regular check ups with the doctor, regular blood tests, as well as diet restrictions, unlike dabigatran.
This drug comes in 75 and 150 mg doses in capsule form, although most patients take a 150 mg dose twice a day. However, patients with kidney problems typically take lower doses of the drug. In addition, patients who abruptly stop taking the anticoagulant or miss any dosages can heighten the risk of stoke.
Before the drug’s entrance into the market, warfarin – with brand name versions Coumadin and Jantoven – was the anticoagulant treatment of choice for patients at risk of stroke, among other diseases, which are caused by blood clots.
Both dabigatran and warfarin are intended to treat patients with atrial fibrillation that do not have any heart diseases but are at risk for stroke and blood clots. During clinical trials, the Boehringer Ingelheim anticoagulant had more effective results as compared to its predecessor.
The two anticoagulants both deliver the same results – prevention of blood clots – but work in different ways. While warfarin decreases the activity of vitamin K (which is essential in blood clot formation), dabigatran suppresses the action of thrombin (a blood clotting protein).
Drug interactions may occur in patients taking other medications like anticoagulants, aspirins, or nonsteroidal anti-inflammatory drugs (NSAIDs). Similar to its counterpart Xarelto, the Boehringer Ingelheim anticoagulant has no antidote.
Symptoms and Side Effects
Common side effects of dabigatran include acid or sour stomach, belching, black/tarry stools, constipation, diarrhea, heartburn, indigestion, nausea, pain or burning in the throat, stomach discomfort, upset, heartburn, burning or pain, vomiting, and vomiting of blood or other materials that look like coffee grounds.
The following symptoms are rare but may still occur in patients using the drug: cough, difficulty swallowing, dizziness, fainting or loss of consciousness, fast heartbeats, fast or irregular breathing, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, redness of the skin, skin rash, hives, welts, or itchy skin, tightness in the chest, trouble breathing, and unusual tiredness or weakness.
Just like other anticoagulants in the market, the drug could cause bruising and bleeding from small cuts in patients using the drug. In fact, risks of bleeding are highest in patients taking the drug who are either (1) aged 75 or older; (2) suffering from kidney problems; and (3) suffering from stomach or intestine bleeding that is recent or recurring because of a stomach ulcer.
In spite of its several common side effects, Pradaxa has a number of adverse side effects like uncontrolled bleeding, heart attacks, liver failure, and death. However, the most reported side effect from using the drug is bleeding, which can cause death. Because the drug is intended to stop blood clot formation, patients taking the drug can suffer from various types of bleeding, even minor ones.
In addition, brain and central nervous system hemorrhages is just as dangerous as stroke, which dabigatran is intended to prevent. Patients who experience the following symptoms must immediately seek a doctor for potential medical treatment:
- Coughing of blood
- Pink or brown urine
- Headaches, dizziness, or weakness
- Unusual bruising
- Vomit which looks like coffee grounds
- Swelling or joint pain
Lawsuits and Litigation
Two years after its release into the market, the anticoagulant was allegedly the cause of over 500 deaths in patients using the drug. Patients and their families have reported occurrences of hemorrhaging as well as uncontrollable bleeding. Many of these patients and families have filed personal injury and product liability lawsuits against Boehringer Ingelheim.
Just like its counterpart, Xarelto, Pradaxa has been linked to numerous adverse side effects, which are potentially fatal in patients. The manufacturers of both drugs have been facing thousands of lawsuits.
Over 2,000 cases linked to this drug have been consolidated into a multidistrict litigation in the U.S. District Court for the Southern District of Illinois. U.S. District Court Judge David Herndon was supposedly going to preside over the bellwether trials. Lawsuits claim that the drug manufacturer failed to properly warn patients regarding the risks of bleeding, in addition to the inexistence of an antidote.
In May 2014, Boehringer Ingelheim settled over 4,000 lawsuits for $650 million. As part of the settlement agreement, the drug manufacturer denied any faults from the drug, claiming that the benefits of the medication compensate for its side effects.
“We continue to stand resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked any merit,” said Andreas Neumann, head of the Legal Department and general counsel for Boehringer Ingelheim worldwide.
In March 2012, Berth Bivens filed a lawsuit in the U.S. District Court for the Eastern District of Tennessee against the drug manufacturer. The lawsuit claims that the company’s marketing of the drug did not “take into account patient safety.”
Also in the same month, Helen and John Hawkins filed a lawsuit in the U.S. District Court for the Eastern District of Kentucky against the drug manufacturer. Helen was hospitalized in March 2011 due to gastrointestinal bleeding after taking the drug to treat her atrial fibrillation.
Atrial fibrillation is found in over 2 million Americans. The condition “is an abnormal heart rhythm characterized by rapid and irregular beating,” which could potentially result in blood pools in the upper chamber of the heart.
Furthermore, the condition can cause chest pains, heart failure, or stroke, which happens when blood clots are relocated to the brain. Patients suffering from atrial fibrillation are five times more at risk of suffering from stroke as compared to those who do not have the condition.
Atrial fibrillation is a condition that varies from person to person. Some patients suffering from this condition may only experience it on certain occasions, and are not disruptive. On the other hand, others may experience the condition as a long-term heart problem with adverse effects.
Most episodes of atrial fibrillation show no symptoms, although it could occasionally cause heart palpitations, fainting, shortness of breath, or chest pain. This condition can also increase the risk of heart failure, dementia, and stroke.
Venous Thromboembolism (VTE)
While dabigatran is not approved in the United States to prevent venous thromboembolism, it is approved for such use in Europe and other countries for patients who have undergone knee or hip replacement surgery – who are at the highest risk of developing this disorder.
Venous thromboembolism is a potentially fatal blood clot that takes form within a vein and its most common kind is a deep vein thrombosis, which is a blood clot that has formed in a vein found in the leg. In the case of the blood clot traveling towards the lungs, the condition becomes a life threatening disease, called a pulmonary embolism. Annually, venous thromboembolism affects 1.5 million and causes the death of 500,000 more patients.
It was in 2012 when the American Heart Association Scientific Sessions showed proof that dabigatran is a safe and effective medication for venous thromboembolism. However, the United States Food and Drug Administration has not yet approved the drug for this use.
Boehringer Ingelheim is currently in the process of conducting clinical trials to show how the drug could be an effective treatment for the disease. If and when the United States FDA approves the drug for this indication, prescriptions for the drug are expected to grow significantly.
FDA Recalls, Reports and Warnings
The Pradaxa label currently carries a black box warning. It states that abrupt discontinuation of drug usage can increase the risk of thrombotic occurrences. This is in addition to the risk of contracting epidural or spinal hematomas in patients receiving neuraxial anesthesia or are undergoing spinal puncture.
In 2011, dabigatran was one of the most mentioned drugs in the United States Food and Drug Administration’s database of adverse event reports, as per QuarterWatch. The FDA received 817 reports linked to the drug in that year alone.
After QuarterWatch – a publication of nonprofit organization Institute of Safe Medication Practices – gathered supplementary reports from manufacturers, databases, and health professionals, it was found that 3,781 adverse side effects related to the drug were reported in 2011, where 542 of which were fatal.
By 2012, at least eight patients have died in United States hospitals from irreparable bleeding linked to the drug. In November the same year, the FDA released a report stating that the drug does not have a higher risk of bleeding as compared to warfarin.
On December 2012, the FDA issued a Drug Safety Communication informing the public that the drug should not be used to prevent stroke or blood clots in patients who have mechanical heart valves, due to its adverse side effects such as increased risks of stroke, heart attack, and blood clots forming in the mechanical heart valves.
On May 2014, the FDA issued yet another Drug Safety Communication regarding the drug. It stated that a study conducted on Medicare patients found that the drug heightened the risk of major gastrointestinal bleeding.
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