Pradaxa (Dabigatran Etexilate)
Pradaxa is an anticoagulant, or blood thinner, most often prescribed to treat and prevent blood clots in patients with atrial fibrillation (without heart valve issues), deep vein thrombosis (DVT), or pulmonary embolism (PE). Pradaxa is also used to reduce the risk of stroke, and to prevent DVT or PE following hip replacement surgery.
Pradaxa is known as a direct thrombin inhibitor, which is a class of anticoagulants. Direct thrombin inhibitors like Pradaxa are so named because they work by inhibiting thrombin, which is a blood-clotting enzyme.
According to its manufacturer, Boehringer Ingelheim, Pradaxa has been growing exponentially in popularity since the U.S. Food and Drug Administration (FDA) approved it in 2010, and has proven to be more effective than the anticoagulant warfarin in reducing certain types of stroke.
However, some studies show Pradaxa carries with it a higher bleeding risk which can turn fatal, and the FDA now warns that there is also an increased risk of blood clots and stroke if you stop taking the medication.
Pradaxa Side Effects and Adverse Reactions
Pradaxa may cause serious side effects, including uncontrolled bleeding which can turn fatal. While internal bleeding is a common risk among blood thinners like Xarelto, it’s the leading cause of death in Pradaxa patients.
The FDA has issued a blackbox warning about stopping the use of Pradaxa, which can increase the risk of bleeding and stroke. Pradaxa can also cause a very serious blood clot in your spinal cord, which can lead to paralysis, if you have a spinal tap or an epidural.
If you’re currently taking Pradaxa, consult your physician before discontinuing use.
Boehringer initially released Pradaxa without an antidote, which caused many patients to suffer from uncontrolled bleeding, which sometimes became fatal. Later, in October 2015, the FDA approved a Pradaxa antidote called Praxbind (idarucizumab), which can reverse the blood thinner’s effects in emergent situations. Of the most recent blood-thinner medications, Pradaxa is the only one with an antidote.
Some experts, however, still advise patients to proceed with caution when considering relatively new blood thinners like Pradaxa and Xarelto.
Pradaxa Drug Interactions
As with any new drug or supplement, it’s important to be aware of any potential interactions it may have with your current prescription or OTC medications. Blood thinners like Pradaxa should not be taken with other medications or supplements that have blood thinning properties, including aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
More than 379 drugs may interact with Pradaxa. Those that are most commonly checked warned against include the following. This list is not all-inclusive, so be sure tell your doctor about any and all medications and supplements you may be taking.
Drugs That Interact with Pradaxa
Pradaxa Deaths and Injuries
A study found that when compared to warfarin, Pradaxa poses an increased risk of severe gastrointestinal bleeding. Pradaxa has also been cited as the cause of rectal and brain bleeding, all leading to more than 4,000 lawsuits.
Approved by the FDA in 2010, Pradaxa didn’t have an antidote to stop its blood-thinning effects until 2015. Doris Daumler of Wisconsin suffered hemorrhaging while on the drug, which ultimately led to her death. Her brother, Walter Daumler, is among those who have filed a lawsuit against Pradaxa’s manufacturer.
According to a New York Times report, 542 patients deaths linked to Pradaxa were reported to the FDA in 2011, and was cited on more report of injury or death than any drug monitored by the Institute for Safe Medication Practices.
In 2012, The FDA warned that Pradaxa should not be used to prevent stroke or blood clots in patients with mechanical heart valves (mechanical prosthetic heart valves) after it was found that Pradaxa patients with these valves were at an increased risk of stroke, heart attack, and blood clots than patients using warfarin.
Prior to the contraindication, Pradaxa was cited as the cause of hemorrhaging and uncontrollable bleeding that led to more than 500 deaths.
Pradaxa Uses & Medical Information
Pradaxa was approved by the FDA in 2010 for stroke prevention in atrial fibrillation in patients without other heart valve issues.
Pradaxa Drug Details
Blood clots, deep vein thrombosis (DVT), traveling blood clots (systemic embolism), pulmonary embolism (PE), stroke
Boehringer Ingelheim Pharmaceuticals, Inc.
Thrombin is a protein found in the blood responsible for clotting, and Pradaxa, an oral anticoagulant, works by blocking its action, keeping the blood flowing smoothly. Other blood thinners known as antiplatelets work by preventing the blood cells known as platelets from clumping together.
Other Approved Pradaxa Uses
Since Pradaxa’s first 2010 approval, the FDA has approved the drug for two additional uses. Then in 2014, Pradaxa was approved for deep vein thrombosis (DVT) and pulmonary embolism (PE), and then for prophylaxis of DVT and PE following hip replacement surgery in 2015.
Clinical Trials: Pradaxa vs Warfarin
RE-COVER I and RE-LY are the earliest Pradaxa clinical trials which ran in 2009. Respectively, their purpose was to compare the safety of Pradaxa to warfarin in treating patients with DVT and PE, and how well Pradaxa works relative to warfarin at mitigating the risk of stroke in patients with atrial fibrillation not caused by a heart valve problem. Traditionally, blood clots have been prevented by taking warfarin.
These trials are said to have shown that Pradaxa is as effective as warfarin for preventing blood clots that lead to stroke, while potentially causing fewer side effects and being easier to use. The makers of Pradaxa claim that it doesn’t require frequent blood tests (warfarin does) and isn’t affected by food (warfarin is).
These head-to-head trials catalyzed Pradaxa’s 2010 FDA approval, but studies since then have shown contradictory results. For example, a University of Pittsburgh survey of 9,400 men and women with atrial fibrillation covered by Medicare showed that among those taking Pradaxa, 9% suffered a major bleed compared to 6% taking warfarin.
Clinical trials are still ongoing and include RE-SPECT ESUS, which is currently recruiting participants with recent embolic stroke of unknown source (ESUS) to study Pradaxa’s ability to prevent a second episode.
Because Pradaxa was sold for five years without an approved antidote, thousands of patients have experienced severe, uncontrollable bleeding and hemorrhaging. This led to more than 4,000 personal-injury and product-liability lawsuits against Boehringer Ingelheim, who settled in May 2014 for $650 million.